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Can, G., Erol, O., Aydiner, A., & Topuz, E. (2011). Non-pharmacological interventions used by cancer patients during chemotherapy in Turkey. European Journal of Oncology Nursing, 15, 178-184. 

Study Purpose

To determine the kind of nonpharmacological interventions used by Turkish patients with cancer for symptom management during chemotherapy, whether a relationship exists between symptom experience and nonpharmacological intervention use, and what personal and illness-related variables predict the symptom experience and nonpharmacological interventions use in this population

Intervention Characteristics/Basic Study Process

Patients completed the following. If patients were unable to complete the tools themselves, a friend or relative verbally asked the patient the questions.

  • Patient Characteristics Form
  • Eastern Cooperative Oncology Group (ECOG) Performance Status scale
  • Nightingale Symptom Assessment Scale (N-SAS)
  • Use and perceived effectiveness of nonpharmacological interventions used during chemotherapy using dichotomous responses (0 = not effective, 1 = yes, effective)

Sample Characteristics

  • The study reported on 202 pages with a mean age of 48.82 years (SD = 1.44 years).
  • The sample was 41.6% male and 58.4% female.
  • Cancer diagnoses were breast (27.2%), colorectal (16.8%), gynecologic (14.4%), lung (13.4%), lymphoma (7.4%), urologic (6.4%), gastric (5.4%), bone (4.5%), head and neck (2.5%), skin and sarcomas (2.0%).
  • Other key sample characteristics include that 66.8% of patients had primary disease and 33.2% had metastatic disease; 58.4% had ECOG performance status of 0 (fully active), 29.7% had ECOG performance status of 1, and 11.9 % had ECOG performance state of 2.

Setting

The study was conducted at a single site, outpatient setting at the Istanbul University Institute of Oncology in Turkey.

Phase of Care and Clinical Applications

Patients were undergoing the active phase of treatment care.

Study Design

This was a descriptive study.

Measurement Instruments/Methods

  • The Patient Characteristics Form had 17 items that addressed demographic, disease, and treatment characteristics at the time of initial diagnosis. 
  • The Eastern Cooperative Oncology Group (ECOG) Performance Status assesses performance status of patients with cancer using six possible number responses.
  • The Nightingale Symptom Assessment Scale (N-SAS) is a Likert -type, quality-of-life scale that includes 38 items addressing symptom experience of patients with cancer during chemotherapy. Three subscales (psychological well-being, social well-being, and physical well-being) are used. The original study using this author-developed scale reported that the subscales have high internal reliability and Cronbach’s alpha values between 0.81 and 0.87 and 0.93 for the overall tool. This study reported Cronbach’s alpha reliability for the subscales as follows.
    • Psychological, 0.88
    • Social, 0.80
    • Physical, 0.85
  • Effective nonpharmacological interventions were identified from the literature and grouped into three subgroups based on the scale’s subgroups of psychological, social, and physical.

Results

  • Physical symptom distress was higher than psychological and social symptom distress.  The most frequent symptoms reported were fatigue (85.1%), nausea (70.8%), alopecia (68.3%), dry mouth (64.4%), and impaired sleep habits (62.9%).  Nonpharmacological interventions used to relieve physical distress included resting (38.2%) and sleeping (12.9%) for fatigue; drinking liquids (9%) and oral care (15.9%) for dry mouth; and exercise (8%) and massage (5.5%) for other physical symptoms. Most subjects (72.5%) preferred pharmacological interventions for physical symptoms.
  • Psychological symptom distress was most frequently addressed by support (7.5%), resting (6.5%), and exercise (1.5%). Only 3% of patients preferred pharmacological interventions for psychological symptoms. Social interventions included pomades for skin and nail changes (19.4%) and berets, scarves and wigs for alopecia (6.5%).  An increase in symptoms “enhanced” the use of the physical and all nonpharmacological interventions in general.  The well-being of women and younger patients and patients who had metastatic disease, surgery, and high ECOG performance scores were low for all subgroups and overall (p < 0.05).
  • Social well-being was lower in patients with breast cancer, patients who received taxane-based therapy, and those who were housewives. Social interventions were more frequently used by university graduates (p = 0.024). Psychological interventions were more often used by students compared to housewives, retired, self-employed people, and working people (p = 0.028). Patients below the age of 50 preferred to use psychological interventions using logistic regression (overall response [OR] = 3.06 [95% confidence interval (CI) = 1.17–7.96]).

Conclusions

Most patients with cancer in Turkey preferred pharmacologic interventions for symptom management.  Exercise, as a recognized evidence-based intervention, was only reported to be used by a few patients. The authors recommended that oncology nurses teach patients more about the side effects of chemotherapy and associated nonpharmacological interventions. Although other studies have produced such evidence-based recommendations, they were not developed from this study of self-reported symptoms and interventions of Turkish people receiving chemotherapy. The authors did not report if or how teaching occurred from the perspective of the nurse or the patient or family.

Limitations

  • No appropriate control group was included.
  • Only patient survey data was used.
  • Data was exclusively from a Turkish patient population at one point in time (which differed among patients) and with various diagnoses and treatments . 
  • No discussion was included comparing these results to results from similar symptom and intervention surveys in other countries and cultures.

Nursing Implications

An individualized assessment of each patient's knowledge and preferences is important to all cultures and practices.

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Campone, M., Berton-Rigaud, D., Joly-Lobbedez, F., Baurain, J.-F., Rolland, F., Stenzl, A., . . . Pautier, P. (2013). A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist, 18, 1190–1191. 

Study Purpose

To investigate if the addition of acetyl-L-carnitine (ALC) to sagopilone (SAG) in patients with ovarian cancer (OC) and castration-resistant prostate cancer (CRPC) reduced the overall incidence of SAG-induced peripheral neuropathy (PN) compared to SAG and placebo, and to evaluate the safety and efficacy of ALC-SAG compared to SAG-placebo

Intervention Characteristics/Basic Study Process

Patients were randomized to treatment and placebo-controlled arms. All patients received a three-hour infusion every three weeks of SAG 16 mg/m2 either with oral ALC (1000 mg) three times a day or oral placebo three times a day for six treatment cycles. ALC or placebo was continued for 30–33 days after the last SAG treatment. Patients with CRPC received oral prednisone 5 mg every two days as standard of care for quality of life.

Sample Characteristics

  • N = 111 completed study (n = 53 [ALC-SAG arm], n = 58 [SAG-placebo arm]) 
  • MEDIAN AGE = 62 years
  • AGE RANGE = 29–82 years
  • MALES 35%, FEMALES 65% (out of total N = 150 enrolled) 
  • KEY DISEASE CHARACTERISTICS: Metastatic/advanced Disease; OC and CRPC patients had no evidence of PN at enrollment.
  • OTHER KEY SAMPLE CHARACTERISTICS: Ovarian cancer International Federation of Gynecology and Obstetrics (FIGO) grades IV (18%), III (69%), II (6%), I (7%); the CRPC median Gleason total score was 8; patients with CRPC taking prednisone 5 mg

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Unknown  
  • LOCATION: Europe

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Phase-II, prospective, placebo-controlled, double-blind, randomized trial

Measurement Instruments/Methods

  • PN was evaluated for time to incidence, time to recovery, and grade of neuropathy within six or fewer cycles.
  • Measurement tools/instruments for evaluation of PN not described
  • Modified Response Evaluation Criteria in Solid Tumors was used to evaluate tumor size.
  • CA-125 blood test
  • Prostate-specific antigen (PSA) blood test

Results

No difference in the incidence or median duration of PN existed in either arm. No difference existed in best overall response, tumor markers, time-to-event variables (progression free survival or time to progression), or discontinuations because of adverse events in either arm. Slightly more serious adverse events and grade 3–4 adverse events were reported in the SAG-placebo arm. ALC reduced the incidence of grade 3–4 PN in patients in the SAG-ALC arm compared to patients in the the SAG-placebo arm; however, actual statistical results were not reported.

Conclusions

ALC given concurrently with SAG in patients with advanced OC was reported to reduce the incidence of grade 3–4 PN after six cycles of treatment; however, no results showing statistical significance were provided.

Limitations

  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10% (26%)
  • Study methods poorly described
  • PN evaluation tool not provided
  • Number of cycles and types of prior regimens in sample not described
  • Inclusion/exclusion criteria not described
  • Statistical methods for analysis of data and significance not described but depicted in tables
  • Patient with CRPC on prednisone could potentially confound results
  • No report of grades or types/frequencies of adverse events in either group
  • No information on what was used as the placebo
 

 

Nursing Implications

ALC concurrently with SAG after six cycles reduced the incidence of grade 3–4 PN in patients with advanced OC. No benefit was observed in patients with CRPC or in reducing the incidence of grade 1–2 for either patients with OC or CRPC. Further randomized, controlled trials are needed to determine the benefits, duration of benefits, and quality of life for ALC-SAG or other neurotoxic regimens in diverse tumor types.

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Campo, R.A., Agarwal, N., Lastayo, P.C., O'Connor, K., Pappas, L., Boucher, K.M., . . . Kinney, A.Y. (2013). Levels of fatigue and distress in senior prostate cancer survivors enrolled in a 12-week randomized controlled trial of Qigong. Journal of Cancer Survivorship, Research and Practice, 8, 60-69.

Study Purpose

To examine the feasibility and efficacy of a Qigong intervention for improving older prostate cancer survivors’ levels of fatigue and distress

Intervention Characteristics/Basic Study Process

Qigong intervention twice weekly sessions for 12 weeks led by Qigong master for one hour with DVD provided for home practice. Qigong incorporated standing and sitting exercise, with increased standing exercise with each session. Exercises included five minutes of meditative breath at the beginning and end of each session, opening of the nine gates, muscle change, cavity presses, collecting energy of heaven and earth, rocking chair, Tai Chi ruler, hands skimming the water, pushing and pulling space, cloud hands, body weight resistance

Stretching intervention led by instructors from the exercise and sport science department twice weekly for one hour for 12 weeks. Avoided movement similar to meditation; used sitting and standing that increased intensity with each session. A DVD also was provided for home practice.

Sample Characteristics

  • N = 29    
  • MEAN AGE = 72 years
  • MALES: 100
  • KEY DISEASE CHARACTERISTICS: Prostate cancer, five-year median diagnosis, 48% on ADT
  • OTHER KEY SAMPLE CHARACTERISTICS: No significant difference was noted between those who completed and those who withdrew from intervention.

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Survivorship and wellness center as well as and home practice

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care 

Study Design

  • Non-blinded RCT, active control

Measurement Instruments/Methods

  • FACIT–Fatigue
  • Brief Symptom Inventory
  • Borg scale
  • Self-report
  • Class attendance and retention

Results

Baseline fatigue between groups was not statistically different. Change in fatigue from baseline was statistically improved in the Qigong group compared to the stretch group (p = .02). Home practice reports were not significantly different. Sixty-nine percent in the Qigong arm had a minimally important difference of 3 or more points compared to 38% in stretching. BSI score between groups was significantly different for somatization (p = .048), anxiety (p = .003), and global severity index (p = .002).

Conclusions

Fatigue and distress were improved in the Qigong group compared to stretching. High attrition was noted in both groups.

Limitations

  • Small sample (< 30)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Subject withdrawals ≥ 10%

Nursing Implications

Qigong as an intervention is a low-risk option for treating fatigue in patients with prostate cancer. Larger RCTs are needed.

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Campeau, M.P., Gaboriault, R., Drapeau, M., Van Nguyen, T., Roy, I., Fortin, B., . . . Nguyen-Tan, P.F. (2007). Impact of massage therapy on anxiety levels in patients undergoing radiation therapy: Randomized controlled trial. Journal of the Society for Integrative Oncology, 5(4), 133–138.

Study Purpose

To assess the impact of massage therapy on intermediate-term anxiety in patients undergoing radiation therapy

Intervention Characteristics/Basic Study Process

Patients were randomized to massage therapy and control groups. Patients in the massage therapy group rated anxiety before and after massage sessions, and control patients rated their anxiety 15 minutes before radiation treatment. All massage sessions took place before the radiation treatment over 10 consecutive days. Massage consisted of a 15-minute chair massage with a combination of effleurage and petrissage. Patients did not disrobe for the therapy, and no lotion was used. Massage therapists participated in a training course specifically targeting the care of patients with cancer. All therapy was standardized, but was adapted as necessary to avoid any massage to the treatment field. The massage therapist assessed anxiety in all patients using a visual analog scale (VAS) every day during the study.

Sample Characteristics

  • The sample included 100 participants.
  • Mean age in the control group was 58 years; mean age in the massage group was 60 years (range = 35–85 years).
  • The sample was 68% females and 32% male.
  • Most participants had breast or head and neck cancers.

Setting

  • Single site
  • Outpatient setting
  • Montreal, Quebec, Canada

Phase of Care and Clinical Applications

Active treatment phase

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Visual Analog Scale (VAS): Ranges from 0 (not anxious at all) to 10 (the most anxious I have ever been), using a 10 cm ruler with a slide bar
  • Spielberger State-Trait Anxiety Inventory (STAI)

Results

The mean VAS score before massage was 4.0 and after massage was 2.2, which was a 45% decrease in anxiety (p < 0.001). Patients in the massage group showed a 15% decrease in anxiety scores from the first to the last session, and patients in the control group experienced a 19% decrease over the same time interval. Both groups had similar scores for state and trait anxiety at baseline. There were no differences in state anxiety between groups at the last session, indicating no intermediate effects on anxiety. VAS scores declined over time for both groups.

Conclusions

Massage therapy as used in this study was associated with a significant immediate reduction in anxiety, but appears to have little or no effect on intermediate-term anxiety. Anxiety over the course of radiation treatment declined for both groups.

Limitations

  • The study had no appropriate control group.
  • The type of massage given was limited (only 15-minute chair massage), which could have influenced results.
  • The control group met with the massage therapist for anxiety assessment, but it is not clear whether this provided an adequate attentional control.
  • Bias may have been present since the massage therapist was the person who administered the VAS assessment to all patients.
  • The study concluded after a 10-day period.
  • The duration of therapy for participants was not described, so it is not clear how this reflected an intermediate point in therapy.
  • The sample size was not sufficient to allow for subgroup analysis to determine potential differences in effect by diagnosis or other subject groups.
  • Baseline VAS scores were relatively low on average in both study groups and was lower in the control group (3.2), which likely influenced effect sizes that could be seen.

Nursing Implications

Findings suggest that a brief chair massage can be effective for immediate reduction in anxiety, and this may be helpful for certain patients who are very anxious in beginning treatments. Because anxiety in all patients declined over time, and all subjects were seen by a massage therapist prior to each treatment, it may suggest that regular attention to anxiety in interaction with patients may be helpful for anxiety reduction over the course of treatment. This is an area that could be studied. The length and type of massage could influence findings, suggesting that further research in this area should incorporate evaluation of various types and duration of massage.

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Campbell, L.C., Keefe, F.J., Scipio, C., McKee, D.C., Edwards, C.L., Herman, S.H., . . . Donatucci, C. (2007). Facilitating research participation and improving quality of life for African American prostate cancer survivors and their intimate partners. A pilot study of telephone-based coping skills training. Cancer, 109(Suppl. 2), 414–424.

Study Purpose

To examine the feasibility and effect of a telephonic cognitive behavioral intervention to facilitate research participation and enhance quality of life among African American prostate cancer survivors and their partners

Intervention Characteristics/Basic Study Process

Consenting patients and their partners provided pretreatment measures and then were randomly assigned to either partner-assisted coping skills training (CST) or usual care (control condition). In the control group, individuals received routine care provided through their medical outpatient program. The CST intervention was designed to train survivors and partners in skills for managing symptoms, including provision of information about prostate cancer and possible long-term side effects, teaching problem solving skills and training in cognitive and behavioral coping skills such as communication, relaxation, and activity pacing. CST was provided in six one-hour telephone calls approximately once a week. Sessions were audiotaped and reviewed for protocol adherence. All subjects completed post-treatment study measures at the end of the six-week period.

Sample Characteristics

  • The sample included 30 patient participants and 30 spouse participants.
  • The mean age was 62.1 ± 8.9 for patients and 58.7 ± 9.8 for partners.
  • Females: Partner gender was not stated, so it is assumed that all partners were female (n = 30).
  • Males: All patients were male (n = 30).
  • All patients had prostate cancer.
  • Time since treatment ranged from 1 week to 4 years, with an average of 18 months.
  • 86% of patients and 93% of partners had completed at least a high school education, 53% of survivors were working full-time, and 37% were retired.
  • Among partners, 46% were working full-time, and 46% were retired.
  • Annual income was $30,000 or greater in 67% of the sample.

Setting

  • Multi-site
  • Outpatient setting
  • Multiple practices and clinics in North Carolina

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Self-Efficacy for Symptom Control Efficacy (SESCI) patient and partner versions
  • Expanded Prostate Cancer Index Composite (EPIC)
  • Short Form 36 (SF-36) physical function and mental health scales
  • Profile of Mood States Short Form (POMS - SF)
  • Caregiver Strain Index (CSI)

Results

Seven couples initially randomized to the treatment group withdrew (approximately 30%) primarily because of difficulties in scheduling treatment sessions.

Men who participated in the CST reported significantly higher quality of life related to bowel symptoms (p = 0.042). There were no significant differences between groups in general health, negative mood among partners, caregiver strain, or caregiver self-efficacy. Within the CST group, pre-post treatment measurement demonstrated significant improvement in reported bowel symptoms (p < 0.05), hormonal symptoms (p < 0.05) and self-efficacy (p < 0.05). There were no significant differences between pre and post-treatment measures among the partners (no effect on caregivers).

Conclusions

The telephone intervention was able to be delivered to the majority of participants, suggesting that this approach may be feasible for the delivery of coping skills training. Significant effects to improve caregiver self-efficacy and experience were not seen. This type of intervention appears to be helpful to patients in the area of managing side effects of prostate cancer.

Limitations

  • The sample had less than 30 participants.
  • Eligible patients had good performance scores for inclusion, and the majority were working full-time. This suggests that the sample was relatively healthy and caregiving needs may have been low. This may have influenced the lack of significant findings among intimate partners related to the intervention.
  • There is no information about what was included in the usual care group in terms of any education, frequency of follow-up, etc.
  • There was no attentional control provided in this study. Although the study demonstrated that the telephonic intervention was feasible for the majority of subjects, there was a 30% attrition rate. This points to practical difficulties in provision of such interventions and suggests that those who completed the study may have been those who were biased in terms of their expectations of effect or were most highly motivated to participate.
  • This is not generalizable to all patients with prostate cancer because the majority of survivors in this study underwent surgical treatment, and the population included only African Americans.

Nursing Implications

Telephonic approaches to provide education, counseling, and CST is a promising approach for the provision of patient care, but scheduling sessions, particularly when patients and caregivers are working full-time, is a challenge. This type of intervention appears to be effective in terms of symptom and side-effect management among patients who are receptive to this type of approach, but the impact on caregiver strain and burden is unclear.

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Campbell, I.R., & Illingworth, M.H. (1992). Can patients wash during radiotherapy to the breast or chest wall? A randomized controlled trial. Clinical Oncology, 4, 78–82.

Study Purpose

To examine the controversy regarding washing the skin during or after a course of radiation therapy (RT)

Intervention Characteristics/Basic Study Process

Participants were randomized to one of three washing policies: (a) not washing, (b) washing with water alone, or (c) washing with soap and water. Assessment of skin reactions was weekly during treatment and at two and four weeks after treatment was completed.

Sample Characteristics

  • The study sample (N = 95) was comprised of female patients.
  • Age ranged from 33–75 years.
  • All patients were receiving postoperative RT following breast local excision or mastectomy.
  • Prescribed doses were 4,500 cGy or 4,700 cGy in 20 fractions in 28 days.

Setting

The study took place at Mercy Clatterbridge Hospital in Bebington, Mercyside, United Kingdom.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • Patients graded their symptoms or itching and pain in the treated skin as none (0) to severe (3).
  • Skin was graded according to the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (EORTC/RTOG) Scale from 0 (none) to 3 (severe).
  • Desquamation was scored as none (0), dryness of the skin (1), moderate flaking (2), severe flaking (3) or patchy moist desquamation (4).

Results

Itching was the main local symptom experienced; it was present at some point in 77% of the patients. In all groups the average itching score rose progressively during treatment, with a maximum at four weeks after starting treatment. Participants randomized to washing had itching scores either similar to or less than those not washing. Several of the comparisons showed a statistically significant reduction in itching at p < 0.05 with washing. Pain in the treated skin was reported by 31% of participants during the observation period. No clear trends were observed in the different washing policy groups. The average scores for erythema rose progressively during observation with a maximum at four to six weeks. There was little difference between washing groups, and a small trend for the non-washing groups to have the highest reactions. Several comparisons showed a statistically significant reduction in erythema associated with washing (p < 0.05). Average scores for desquamation showed maximum reactions at six to eight weeks after starting treatment. Patients who were washing had markedly lower scores than patients who were not washing, with some comparisons reaching statistical significance (p < 0.05 washing compared with p < 0.01 not washing).

Conclusions

Findings support allowing patients to wash during RT with either soap and water or water alone.

Limitations

  • Generalization of findings is not completely clear.
  • Approximately half of the participants were prescribed a topical cream for their skin reaction (n = 45), and whether the cream had any effect on study findings is not clear.
  • No restriction was placed on the frequency of washing in any of the groups.
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Campbell, M.L., Yarandi, H., & Dove-Medows, E. (2012). Oxygen is nonbeneficial for most patients who are near death. Journal of Pain and Symptom Management, 45(3), 517-523.

Study Purpose

The objective of the study is to determine if routine application of oxygen in patients who were near death would be beneficial as measured by relief of distress.

Intervention Characteristics/Basic Study Process

At baseline, a trained observer who was blinded to the current type of NC flow (oxygen or medical air) of the patient collected data about the respiratory status of each patient. Patients not in respiratory distress were then randomly alternated through low-flow oxygen, medical air, or room air on an NC on a 10-minute washout rotation. Each patient received each type of air twice for a total of six rotations per patient.

Sample Characteristics

  • The study reported on a sample of 32 patients who ranged in age from 56-97 years.
  • The sample was 34% males and 66% females.
  • Included in the study were patients who were referred for palliative care consultation, enrolled in hospice, near death, at risk for respiratory distress, and institutionalized.
  • The study reported on a limited number of patients with cancer (9% lung cancer, N = 3).

Setting

The multi-site study was conducted in a university hospital or free-standing hospice facility in the Midwestern United States.

Phase of Care and Clinical Applications

  • Patients were undergoing end-of-life care.
  • The study has clinical applicability for palliative care.

Study Design

The double-blind study repeated measures with patient as own control.

Measurement Instruments/Methods

  • Respiratory distress observation scale (RDOS) - observation of respiratory distress symptoms
  • Palliative performance scale (PPS) - nearness to death
  • Reaction Level Scale (RLS85) to assess consciousness
  • Oxygen saturation and end tidal carbon dioxide via Nellcor N-85 capnograph/oximeter (Covidien, Mansfield, MA)

Results

Most patients (84%) had oxygen flowing at baseline. Three patients did not tolerate switching from oxygen to no flow and were restored to baseline with no further rotations. One patient died during the fourth gas/flow encounter without increased distress. No oxygen adverse effects (e.g., nosebleeds) occurred during the study. Average baseline respiratory distress was 1.47 (scale 0-4), with no difference over the study period. Baseline oxygen saturation and RDOS were inversely related. Neither consciousness nor nearness to death correlated to baseline RDOS, but consciousness was significantly correlated to nearness of death.

Conclusions

Routine application of oxygen does not reduce dyspnea at the end of life and should be used as an n of one trial in patients near death with observed dyspnea.

 

Limitations

  • The study had a small sample size of less than 100.
  • The study had a risk of bias due to sample characteristics and no blinding.
  • Key sample group differences could influence results.
  • This small sample size with different medical diagnoses may not account for different types of airway/respiratory compromise and the potential variance in benefit from oxygen (e.g., heart failure, secretions, airway obstruction).

Nursing Implications

Oxygen administration near the end of life for management of observed dyspnea is scientifically logical, but this study suggests no proven clinical benefit. Costs to bring oxygen into the home and train caregivers in its administration may not be necessary based upon this study’s findings. In addition, the addition of the oxygen delivery device may be uncomfortable or produce unwanted adverse effects. The limited number of patients with cancer in this study limits generalizability to this population.

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Cameron, J.I., Shin, J.L., Williams, D., & Stewart, D.E. (2004). A brief problem-solving intervention for family caregivers to individuals with advanced cancer. Journal of Psychosomatic Research, 57, 137–143.

Study Purpose

To evaluate an intervention that was designed to improve the problem-solving abilities of family caregivers* of patients with advanced cancer**. Authors tested whether the intervention (a) enhanced positive problem-solving skills and decreased negative problem solving, (b) enhanced confidence in caregivers’ ability to perform caregiving activities, and (c) decreased caregivers’ emotional distress.

* Caregivers were defined as those unpaid family members assuming responsibility for homecare needs of an individual with advanced cancer.
** Advanced cancer was defined as patients with estimated survival prognosis of three to six months.

Intervention Characteristics/Basic Study Process

A one-hour intervention used explanations and a slide presentation or flip charts of problem solving. The intervention was given to caregivers only once, at the time of recruitment. The intervention involved:

  1. Introducing examples of problem-solving techniques from a Home Care Guide  for Advanced Cancer, which was developed by the American College of Physicians to help caregivers COPE (be Creative, Optimistic, Plan, and obtain Expert information).
  2. Encouraging the caregivers to use a five-step approach to address problems. These steps were to (a) define the problem, (b) identify when to seek professional help with the problem, (c) identify what they (caregivers) could do to help, (d) consider possible obstacles to their caregiving plan, and (e) carry out and adjust the plan.

Sample Characteristics

  • The sample included 34 family caregiver participants.
  • Mean age of caregivers was 53.6 years. No SD or range was mentioned.
  • Caregivers were 67.6% (n = 23) female and 32.4% (n = 11) male.
  • Caregivers had to be those giving care to patients diagnosed with advanced cancer, defined as having an estimated survival prognosis of three to six months.
  • To be included in the study, participants had to be 18 years or older, be able to speak and read English, be able to give written consent, and be clear of severe visual, hearing, or cognitive impairments that would interfere with their ability to participate.

Setting

  • Single site
  • Inpatient setting
  • Teaching hospital (University Health Network in Toronto, Ontario, Canada): While the patient attended a clinical visit, the research assistant met separately with the caregiver.

Phase of Care and Clinical Applications

  • End-of-life care phase
  • Elder care; palliative care

 

Study Design

A one-sample pretest/post-test design was used. There was no control group. Survey data were collected at baseline (recruitment) and then by phone four weeks after the intervention was done.

Measurement Instruments/Methods

  • Social Problem-Solving Inventory–short form (SPSI-SF): Used to assess caregivers’ ability to problem-solve. The scale has five subscales representing: (a) positive problem-solving orientation, (b) negative problem-solving orientation, (c) rational problem-solving orientation, (d) impulsivity/carelessness scale, and (e) avoidance style scale.
  • Profile of Mood States–short form: Used to assess emotional well-being. This was an established and reliable tool. The scale includes six subscales: (a) tension-anxiety, (b) depression-dejection, (c) anger-hostility, (d) fatigue-inertia, (e) vigor-activity, and (f) confusion-bewilderment.
  • Caregiver Assistance Scale (CAS): Used to assess the level of assistance provided by caregivers to patients in activities of daily living, instrumental activities of daily living, and treatment-related activities. This was an established and reliable scale.
  • Caregiver Self-Efficacy Scale: Developed by the authors to assess caregivers’ confidence in their ability to perform each of the caregiving activities. The seven-point scale has ratings ranging from one (not very confident) to seven (very confident). The authors averaged the scores, yielding an overall confidence score ranging between one and seven, with higher scores indicating greater confidence. They calculated an excellent internal consistency of this developed scale in the sample (α = 0.90).

Results

The authors provided a good description of how the original sample went from 112 to 34 caregivers, and the basis for attrition or exclusion were reviewed clearly, giving good insight into factors to consider when researching this group of caregivers of patients with advanced cancer. Reasons that led to shrinking of the sample included (a) some patients who were identified with advanced cancer did not need assistance at home, thus they did not have caregivers (n = 7), (b) some caregivers declined participation (n = 34), (c) some participating caregivers did not complete baseline survey because they changed their mind, their patient died, they were not coming back to the hospital in time to complete the intervention, or they had English language difficulty (n = 13), (d) some caregivers who completed the baseline data did not come back later to receive the intervention (n = 11), (e) some caregivers completing the baseline data and the intervention did not complete the follow-up survey (n = 6), and (f) some caregivers were wrongly identified (patients had advanced cancer but responded to curative treatments, or patients were outliers in terms of the length of time they had been diagnosed with advanced cancer) (n = 7).

Other significant findings include the following.

  • One significant difference was identified between participant and nonparticipant characteristics: Participants gave care to patients who had cancer for a shorter period of time.
  • The mean time between baseline assessment and follow-up assessment was 4.8 weeks (1.28).
  • Caregivers showed significant improvement in their positive problem-solving (mean score at baseline [pretest] was 12.3 [3.56] and at follow-up was 13.7 [3.80], p = 0.054); the authors used a p level of 0.06 to judge significance for this finding.
  • Caregivers showed significant improvement in their confidence in caregiving activities (mean at baseline [pretest] was 6.1 [0.65] and at follow-up was 6.3 [0.60], p = 0.059); the authors used a p level of 0.06 to judge significance for this finding.
  • Caregivers showed significant improvement in emotional tension (mean at baseline was 1.5 [0.97] and at follow-up was 1.2 (0.85), p = 0.024).
  • There was a significant positive correlation between caregivers’ reported levels of fatigue at baseline and their level of impulsivity/carelessness problem-solving subscale score (SPSI-SF) at follow-up (r = 0.40, p < 0.02).

Conclusions

Overall, the findings clearly show potential evidence that the intervention affected caregivers positively. Given that improvements were noted even though participants already showed that they have good levels of confidence in their abilities and problem-solving skills at baseline, the findings strongly suggest that the intervention might have even greater potential among those with lower levels of confidence in their caregiving and problem-solving abilities. The intervention influenced one aspect of emotional well-being (tension subscale) and one aspect of problem-solving (positive problem-solving subscale), suggesting that a modified or more comprehensive or frequent intervention may improve other aspects of emotional well-being or problem-solving. Researchers of caregivers of patients with advanced cancer should consider and address the serious challenges that they may encounter in recruiting this group of caregivers.

Limitations

  • The sample was small, with less than 100 participants.      
  • Baseline sample and group differences existed.  
  • Risk of bias existed due to no control group, no blinding, and no random assignment.
  • Key sample group differences existed that could influence results.*
  • Subject withdrawals were 10% or greater.
  • No information was provided about whether the research assistant who conducted the intervention with participating caregivers had received or had training or expertise in training others in problem-solving. This is an important piece of information because the value or influence of the intervention would be as good as the training that the caregivers received. 
  • The study sample was reduced by 50% of caregivers consented to the study.
  • * The findings regarding significant improvements in caregivers' confidence and positive problem-solving are borderline, and one can argue that p levels of 0.059 and 0.054 are bordering significance but not significant as the authors interpreted them. The customary p level is < 0.05; with no correlations shown, it is hard to accept the interpretation as significant as the authors relaxed the p level to 0.06.

Nursing Implications

Nursing care of patients with advanced cancer should be extended to include care of their caregivers, as they are key in providing care at home. This brief problem-solving intervention significantly improved the emotional tension in caregiver participants, suggesting the value of its use in palliative care settings. The fact that a significant difference existed between participants and nonparticipants in relation to the length of time their patients were diagnosed with cancer suggests that the longer caregivers provide care, the less likely they would be to participate in interventions. This suggests that they (a) may have figured out on their own how to manage the caregiving burden, or that they are too exhausted to participate, or (b) need different types of interventions that meet them where they are, either at home or in their locale, rather than require them to drive to where interventions would be conducted. This findings suggest that researchers may need to focus on caregivers of patients with new onset of disease or those who have had the disease for a short period. Any interventions with these caregivers should be set up in a way that decreases the demand on their time and meet them where they are. Thus, there is a need not only to develop short and effective interventions but also to find ways in which such interventions can be delivered/conducted with caregivers at home.

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Cameron, L.D., Booth, R.J., Schlatter, M., Ziginskas, D., & Harman, J.E. (2007). Changes in emotion regulation and psychological adjustment following use of a group psychosocial support program for women recently diagnosed with breast cancer. Psycho-Oncology, 16, 171–180.

Intervention Characteristics/Basic Study Process

A 12-week structured psychosocial support group of weekly two-hour sessions was led by two facilitators using an adapted form of Cunningham’s “Healing Journey” program. The intervention included training in relaxation, guided imagery, meditation, emotional expression, and exercises promoting control beliefs and benefit-finding. The prospective design included 10 phases to recruit, and 8–11 women were recruited for each group. Data were collected at baseline and at 4 months (corresponding to the end of the intervention), 6 months, and 12 months.

Sample Characteristics

  • The study reported on a sample of women newly diagnosed with breast cancer.
  • Women participated in one of three conditions: intervention group (n = 54), standard care group (n = 44), and decliner group who refused the intervention (n = 56).

Setting

New Zealand

Study Design

A quasi-experimental study design was used.

Measurement Instruments/Methods

  • Cortauld Emotional Control Scale: emotional suppression
  • Illness Perceptions Questionnaire–Revised: perceived control
  • Perceived Risk of Recurrence: two items, 1–10 scale
  • Benefit-Finding Scale for Breast Cancer
  • Functional Assessment of Cancer Therapy (FACT): emotional well-being subscale
  • Cancer Worry: two items, 1–10 scale
  • State-Trait Anxiety Inventory: state anxiety
  • Coping Efficacy: measured five items

Results

Repeated measures ANOVAs revealed group differences in state anxiety over the first four months. Scores decreased for intervention participants, but not the standard care or decliner participants. Anxiety decreased overall from baseline to 6 months and from baseline to 12 months. Longitudinal follow-up occurred over 12 months.

Limitations

  • The study had no randomization.
  • The study had a high level of decliners.
  • The intervention required special training of facilitators to use the program.
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Callow, C.R., Swindell, R., Randall, W., & Chopra, R. (2002). The frequency of bleeding complications in patients with haematological malignancy following the introduction of a stringent prophylactic platelet transfusion policy. British Journal of Haematology, 118, 677–682.

Study Purpose

Prophylactic platelet transfusion policy

Intervention Characteristics/Basic Study Process

Comparison of platelet usage to nine months preceding intervention

Sample Characteristics

  • N = 98
  • KEY DISEASE CHARACTERISTICS: Inpatients with hematologic malignancy; all had prolonged pancytopenia; some patients had undergone transplant

Study Design

  • Intervention trial that was nonexperimental, not randomized

Measurement Instruments/Methods

  • Protocol: less than 10–all, 10–20—bone marrow biopsy, pyrexia greater than 38, coagulation disorder, major bleed; 20–50—major bleed, soft tissue bleed, fresh retinal hem, disseminated intravascular coagulation (DIC), hemorrhagic cystitis; greater than 50—surgery
  • Bleeding defined by World Health Organization (WHO) criteria (grade 0: no bleeding; grade 1: petechiae; grade 2: mild blood loss; grade 3: gross blood loss; grade 4: debilitating blood loss)
     

Results

  • Less than 10k—13 bleeds
  • 10–20k—27 bleeds
  • Greater than 20k—117 bleeds (18 DIC and 54 hemorrhagic cystitis); one death with DIC
  • Transfusion trigger less than 10k in absence of fresh bleeding and sepsis is safe.
     

Limitations

  • Type of chemotherapy not controlled
  • Fifty-four episodes of bleeding were hemorrhagic cystitis
  • Bleeding episodes not separated by patient (one patient with 32 episodes)
  • Platelet usage was compared, but bleeding was not.
  • Rubella et al. (1997) with further support of 10k platelet level
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