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Davidson, J. R., Waisberg, J. L., Brundage, M. D., & MacLean, A. W. (2001). Nonpharmacologic group treatment of insomnia: a preliminary study with cancer survivors. Psycho-oncology, 10, 389–397.

Intervention Characteristics/Basic Study Process

Participants received multimodal cognitive-behavioral group therapy in six 1- to 1.5-hour sessions, given weekly x5 and then repeated in four weeks. Therapy included stimulus control therapy, relaxation training, sleep consolidation strategies, and strategies to reduce cognitive-emotional arousal.

Sample Characteristics

  • Fourteen patients, including 11 women, were included, and 12 completed the study.
  • Mean age was 54.7 years. 
  • Median time from diagnosis was 33.6 months.

Setting

Outpatient clinics at Major Cancer Center in Central Canada and the community serving the Cancer Center, Midwestern Canada

Study Design

This was a repeated measure, single-group design with no control group.

Measurement Instruments/Methods

  • Fatigue subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Sleep
  • Anxiety
  • Depression

Results

Fatigue significantly decreased at week eight in comparison to baseline. Values of sleep, mood, and functioning improved from baseline, to four weeks, and to eight weeks after the intervention. Improved sleep measures included

  • Number of awakenings
  • Wake after sleep onset
  • Sleep efficiency
  • Sleep Impairment Index.

Limitations

  • The study had a small sample size.
  • Participants were relatively healthy.
  • Only self-reports were used.
  • There was no placebo control group.
  • The duration of the effects after eight weeks is unknown.
  • Space to provide intervention.
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Das, A., Chattopadhyay, S., Mandal, D., Chhaule, S., Mitra, T., Mukherjee, A., . . . & Chattopadhyay, S. (2015). Does the preoperative administration of tranexamic acid reduce perioperative blood loss and transfusion requirements after head neck cancer surgery? A randomized, controlled trial. Anesthesia, Essays and Researches, 9, 384–390. 

Study Purpose

To determine the effectiveness of a preoperative bolus dose of tranexamic acid on the amount of blood loss and transfusions required during surgery for patients with head and neck cancer

Intervention Characteristics/Basic Study Process

The study participants were randomly selected into two groups. One group received 25 ml of normal saline only (control group) over five minutes through the IV route. The second group received 20 mg/kg dose of tranexamic acid diluted in 25 ml of normal saline over five minutes through the IV route. Both groups received the intervention 15 minutes prior to the initiation of anesthesia prior to surgery. Labs were done preoperatively, and in the first 6 and 24 hours postoperatively.

Sample Characteristics

  • N = 80
  • AGE = 35–55 years
  • CURRENT TREATMENT: Surgery
  • KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer having surgery
  • OTHER KEY SAMPLE CHARACTERISTICS: No significant results
 

 

Setting

  • SITE: Single site
  • SETTING TYPE: Tertiary care hospital
  • LOCATION: India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

 

Study Design

  • Double-blind randomized, controlled trial (RCT)

Measurement Instruments/Methods

  • Student’s t test
  • Chi-squared test

Results

Total blood loss was significantly higher in the control group when compared to the treatment group (p = 0.0001), requiring more blood transfusions both during the operation and at 24 hours post-procedure points. Even after transfusions, the control group’s hemoglobin remained significantly lower at 6 and 24 hours post-procedure (p < 0.05).

Conclusions

The use of tranexamic acid infusion prior to surgery for patients with head and neck cancer has shown significant reduction in blood loss during and following the procedure. With no reported adverse side effects with the use of this medication, the benefits outweigh any potential risks. The intervention will need to be studied in other disease state procedures to recommend use prior to all cancer surgeries.

Limitations

  • Small sample (less than 100)
  • Optimal dose of tranexamic acid would need to be tested with a larger study.
  • Study done in developing country limited the types of biochemical parameters of bleeding episodes measured.

Nursing Implications

Nurses practicing in the surgical oncology field will be interested in these findings, as they can help them improve patients' quality of life during and after surgery for head and neck cancer. By reducing the amount of allogeneic red blood cell transfusions patients receive, The use of tranexamic acid prior to surgery is improving lives by reducing the amount of allogeneic red blood cell transfusions patients need.

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Daniele, B., Perrone, F., Gallo, C., Pignata, S., De Martino, S., De Vivo, R., … D'Agostino, L. (2001). Oral glutamine in the prevention of fluorouracil induced intestinal toxicity: A double blind, placebo controlled, randomised trial. Gut, 48(1), 28–33.

Study Purpose

To evaluate the effect of glutamine on intestinal absorption and permeability in patients with colorectal cancer

Intervention Characteristics/Basic Study Process

Patients receiving their first cycle of chemotherapy with 5-fluorouracil (5-FU) and folinic acid (FA) for five days were randomly assigned to receive either 18 g glutamine or placebo for 15 consecutive days, beginning 5 days before chemotherapy initiation. The experimental dose (18 g) was much greater than the normal dietary intake (1 g).
 

Sample Characteristics

This study reported on 70 patients with colorectal cancer who were chemotherapy naïve. 

Study Design

This was a randomized, double blind, placebo-controlled, two armed, parallel trial.

Measurement Instruments/Methods

Intestinal absorption (IA) was measured using d-xylose absorption test and intestinal permeability (IP) using cellobiose-mannitol permeability test.  Both of these tests have been confirmed to be reliable and sensitive in clinical conditions characterized by disruption of the normal small intestinal mucosa (e.g., celiac disease, Crohn’s disease).

Results

  • For both groups, chemotherapy induced worsening of IA and IP. When pretreatment IA was compared to post-treatment IA, reduction in IA was significantly greater in the placebo group (p = 0.02).
  • The placebo group experienced a higher incidence of diarrhea, but this was not statistically significant (p = 0.09).
  • The placebo group used significantly more loperamide (p = 0.002). No differences were found in episodes of nausea, vomiting, or hematologic toxicity.
     

Conclusions

Glutamine was shown to reduce changes in IA and IP during 5-FU chemotherapy and may have a protective effect against diarrhea by enhancing the barrier function of the intestine.

Limitations

  • The sample size needed for statistical analysis was 70, but only 62 patients were included in the final analysis.
  • The findings are applicable to chemotherapy using 5-FU and FA only.

Nursing Implications

This study used sensitive and reliable tests to evaluate the morphological changes to the intestine that are casually related to diarrhea incidence. The results are consistent with previous studies that have demonstrated the protective effects of glutamine on the intestinal mucosa.

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Danhauer, S. C., Tooze, J. A., Holder, P., Miller, C., & Jesse, M. T. (2008). Healing touch as a supportive intervention for adult acute leukemia patients: a pilot investigation of effects on distress and symptoms. Journal of the Society for Integrative Oncology, 6, 89–97.

Study Purpose

To determine the feasibility of conducting a randomized, clinical trial testing the effectiveness of healing touch (HT) for patients undergoing induction for acute leukemia and to obtain preliminary data to determine the effect size.

 

Intervention Characteristics/Basic Study Process

A prospective cohort of patients was selected to participate in the intervention trial. They completed self-report questionnaires and rated fatigue, nausea, pain, and distress at baseline, within seven days of hospital admission. Follow-up data collection was performed during the fifth week of hospitalization or prior to discharge. The HT intervention consisted of nine 30-minute sessions during weeks 2, 3, and 4. Family members were allowed to stay or leave during the session, depending on patient preference. All who provided the sessions were certified and had at least two years of experience with HT. All sessions were provided to the patient by the same practitioner. Sessions were standardized and included (1) the practitioner setting an intention for the patients’ highest good and (2) a standardized sequence of hand positions progressing from the ankles upward to the top of the head, with the hands placed either touching the patient or several inches above the body for one minute.

Sample Characteristics

  • The sample was comprised of 12 patients (33.3% male, 66.7% female).    
  • Mean age was 59.8 years (standard deviation = 10.7 years).
  • Of the patients, 91.7% had acute myeloid leukemia (AML), 8.3% had acute lymphoblastic leukemia (ALL), and 66.7% were in relapse.
  • Of the patients, 75% had at least some college level education, 50% were employed, and 100% were white.

Setting

  • Single site  
  • Inpatient 

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a prospective trial.

Measurement Instruments/Methods

  • MD Anderson Symptom Inventory (MDASI):  13 symptoms rated from 0 (not present) to 10 (as bad as you can imagine) for severity; six items rate the degree to which symptoms interfered with functioning on the same type of 11-point scale
  • Women’s Health Initiative Insomnia Rating Scale (WHIIRS):  five-item measure of sleep quality
  • Profile of Mood States Short Form (POMS-SF):  37 items on a five-point Likert scale
  • Distress Thermometer
  • Self-rating of symptoms on a 0- to 10-point scale
  • Questionnaire to obtain general feedback on the HT intervention
     

Results

Of the individuals approached for study participation, 48% declined (66% due to lack of interest and 34% due to medical issues or feeling too ill). Three patients who initially entered withdrew, one due to family request and concerns about interference with medical treatment, one due to medical complications, and one after speaking with his minister who had religious objections to participation.

There were no significant changes from baseline to the five-week follow-up measurement on the MDASI, sleep quality measures, or POMS.

There were significant improvements on the patient self-report scale for fatigue (–1.8 change; p < 0.01) and nausea (–0.5 change; p < 0.01). Changes in distress were not significant. There were no changes in pain, and baseline values for pain were low (median = 1), although patient feedback suggested short-term pain reduction and improved sleep.

Of the patients, 91% liked HT “very much,” and most stated they felt more calm and relaxed during and after the sessions. All said they would recommend HT to others, and eight patients (73%) wanted to continue using HT.

Patients suggested improvements of providing a better explanation of HT, offering longer and more frequent sessions, and offering 30 minutes of protected quiet time for patients in addition to HT sessions.

Conclusions

The study demonstrated that use of HT in the acute setting is feasible and may benefit patients.

Limitations

  • The study had a very small sample size. 
  • No comparison group was included. 
  • Because patients suggested protected quiet time, it is not clear if the benefits seen were from the HT or from the fact that the sessions provided such uninterrupted time.

Nursing Implications

The study findings suggest that a simple intervention of providing protected, uninterrupted quiet time to patients can be helpful to patients. This is something that could be readily incorporated into nursing care. Findings suggest that further research in this area is feasible in acutely ill patients. Findings suggest that provision of quiet time control in further research would be a viable approach, as well as comparison to other strategies to elicit a relaxation response. Information regarding drop-out reasons suggest that more extensive explanation of HT and mechanisms of effects is warranted with use of HT.

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Damstra, R.J., Voesten, H.G., van Schelven, W.D., & van der Lei, B. (2009). Lymphatic venous anastomosis (LVA) for treatment of secondary arm lymphedema. A prospective study of 11 LVA procedures in 10 patients with breast cancer related lymphedema and a critical review of the literature. Breast Cancer Research and Treatment, 113(2), 199–206.

Study Purpose

To evaluate the effectiveness of lymphatic venous anastomosis (LVA) in the treatment of one-sided, breast cancer-related lymphedema

Intervention Characteristics/Basic Study Process

Unilateral lymphoscintigraphy was done with attention to liver uptake, and methylene blue was used to outline the lymphatic system. An experienced microvascular surgeon did the LVA procedures doing end-to-side anastomoses with micro instruments. Antibitoitics were used preoperatively, and the extremity was bandaged and elevated at night. Patients were followed at three months, six months, one year, and beyond. The mean final follow up was eight years.

Sample Characteristics

  • The study sample was comprised of 10 female patients.
  • Mean age was 58.7 years, with a range of 46-68 years.
  • All patients were postmastectomy and had persistent lymphedema that had not responded to more conservative interventions.
  • Lymphedema was present for a mean of 5.3 years before LVA.

Setting

The study took place at a single site in the Netherlands.

Study Design

The study used a prospective descriptive design.

Measurement Instruments/Methods

  • Arm volume was measured using inverse water volumetry method.
  • The SF-36 measured quality of life. 
  • Indirect circumferential measurement of limbs was taken.
  • Patients underwent lymphoscintigraphy. 

Results

After six months, 5 of 10 patients had subjective relief according to SF-36 results. After one year, the mean volume difference between limbs was 1,075 cc, with a range of 500-1856, and the circumferential measurement demonstrated improvement of 4.8%. An initial postoperative volume reduction seen at 16% was lost in one year, at which time no more than a 2% difference between limbs was observed.

Conclusions

No significant improvements were found over the long term after an initial period of symptom relief and volume reduction.

Limitations

  • The study sample was small, with less than 30 patients.
  • The study did not have a comparison or control group. 

Nursing Implications

The small prospective study suggests there is no long-term benefit of LVA surgery for management of lymphedema associated with breast cancer.

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Damstra, R.J., & Partsch, H. (2009). Compression therapy in breast cancer-related lymphedema: A randomized, controlled comparative study of relation between volume and interface pressure changes. Journal of Vascular Surgery: Official Publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter, 49(5), 1256–1263.

Study Purpose

To determine whether there is a difference between low- and high-pressure bandaging in intended volume reduction

Intervention Characteristics/Basic Study Process

Bilateral arm volume was measured before, two hours post-bandage placement, and after 24 hours. The amount of edema was calculated. Sub-bandage pressure was measured after bandage application and two hours later. Bandages were re-applied and pressure measurements were repeated. After 24 hours, pressure measurement was recorded and bandages were removed for final volumetry. Primary outcome measures were reduction of arm volume and edema in both study groups. Secondary outcomes were changes in sub-bandage pressure and patient comfort later. Patients were randomized into two groups: group A received low pressure bandages (20–30 mm Hg) and group B received high pressure bandages (44–58 mm Hg). 

Sample Characteristics

  • The sample (N = 36) was comprised of female patients aged 45–84 years.
  • All patients had unilateral breast cancer-related lymphedema (moderate-to-severe edema [volume difference 20%–40% and greater than 40%, respectively).
  • Patients were included in the study if they were at least 18 years of age, a minimum of 12 months post-treatment for breast cancer without signs of recurrence, and hospitalized because outpatient treatment was not successful.
  • Patients with allergies to any of the materials, severe systemic diseases, acute superficial or deep vein thrombosis arterial occlusive disease, or confirmed thrombophilia were excluded.

Setting

The study took place at Nij Smellinghe Hospital in Drachten, Netherlands.

Study Design

The study used a randomized, controlled comparative design.

Measurement Instruments/Methods

  • Bilateral arm volume was measured by inverse water volumetry.
  • Sub-bandage pressure was measured after bandage application and two hours.
  • The main outcome measures were reduction of arm volume and edema volume in the affected arm in both study groups.
  • Secondary outcome parameters were changes in sub-bandage pressure and patient comfort.
  • Air-filled pressure transducer with a large probe was used to measure sub-bandage pressure.
  • Accuracy and variability of this method was referenced.

Results

Median arm volume reduction after two and 24 hours was 104.5 ml (95% confidence interval [CI], 51.2–184.2) (–2.5%) (p < 0.0001) and 217 ml (95% CI, 143.9–280.2) (–5.2%) (p < 0.01) for group A and 56.5 ml (95% CI, 2.7–123.1) (not significant) and 167.5 ml (95% CI, 105.2–316.1) (–4.2%) (p < 0.01) for group B, respectively. There was no statistically significant difference between the volume changes in group A and group B. Bandages in group A were better tolerated. The sub-bandage pressure drop in the first two hours was between 41% and 48% in both treatment groups at both measuring sites. After 24 hours, the pressure drop was between 55% and 63%. No proximal swelling above the bandage was observed.

Conclusions

Inelastic, multi-layer, multi-component compression bandages with lower pressure (20–30 mm Hg) were better tolerated and achieved the same amount of arm volume reduction as bandages applied with higher pressure (44–58mm Hg) in the first 24 hours.

Limitations

The sample size was small (N < 100).

Nursing Implications

More studies are needed to evaluate efficacy of lower pressure to better understand optimal treatment and tolerability, which will impact compliance.

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Damstra, R.J., Brouwer, E.R., & Partsch, H. (2008). Controlled, comparative study of relation between volume changes and interface pressure under short-stretch bandages in leg lymphedema patients. Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [Et Al.], 34(6), 773–779.

Study Purpose

To demonstrate that therapeutically intended volume reduction of the compressed leg is the most important cause for the loss of bandage pressure

Intervention Characteristics/Basic Study Process

All patients and control group volunteers were treated with the same bandages by trained staff. The bandages started at the base of the toes and covered the leg up to the capitulum fibulae in all cases. The bandages were removed after two hours, and new bandages were applied for the next 24 hours. On the first day, all patients were encouraged to walk and treated exclusively with compression therapy of the whole leg. No other therapeutic interventions were performed.

Sample Characteristics

  • The sample size (N = 29) was comprised of 20 patients (75% female and 25% male) for the study group and 9 healthy volunteers for the control group. 
  • Mean age of the study group only was 51.1 years with a range of 20–78 years. Mean age for the control group was not available. 
  • The study group consisted of patients who had been hospitalized for extensive lymphedema of the lower extremities.

Setting

  • Single site
  • Inpatient unit
  • Netherlands

Study Design

The study used an experimental, controlled comparative design.

Measurement Instruments/Methods

  • Sub-bandage pressure was measured by an air-filled pressure transducer.
  • A water displacement device was used to measure leg volumetry.

Results

A significant reduction of leg volume was achieved two hours after bandage application in both groups. A further volume decrease of the lymphedematous legs was observed in the following 24 hours after application of a new bandage. The volume reduction was associated with a significant loss of bandage pressure.

Conclusions

Volume reduction is the most important cause of loss of pressure and effectiveness, supporting the need for proper materials, technique, and compliance.

Limitations

  • The sample size was small (N < 30). 
  • The study was conducted at a single site.

Nursing Implications

More frequent bandage changes, in the initial phase of edema reduction in patients with venous diseases, with compression treatment using short-stretch bandages appears to be necessary.

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Damian, S., Celio, L., De Benedictis, E., Mariani, P., Agustoni, F., Ricchini, F., & De Braud, F. (2013). Is a dexamethasone-sparing strategy capable of preventing acute and delayed emesis caused by combined doxorubicin and paclitaxel for breast cancer? Analysis of a phase II trial. Oncology, 84(6), 371–377. 

Study Purpose

To evaluate the effectiveness of palonosetron without delayed dexamethasone in breast cancer patients receiving doxorubicin and paclitaxel (AT) for three cycles

Intervention Characteristics/Basic Study Process

Palonosetron 0.25 mg IV was given as a premedication in combination with prednisone 25 mg PO the night before chemotherapy and hydrocortisone 250 mg IV just prior to paclitaxel. Patients were then asked to record their nausea, vomiting, and use of antiemetics on a home record. The severity of nausea was graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for the first five days of each cycle.
 
The primary endpoint of the study was to evaluate complete control of chemotherapy-induced nausea and vomiting (CINV) during the first five days of the first cycle. If patients completed the first cycle satisfactorily, they had the option to continue in the study with this premedication regimen for two additional cycles (up to three cycles) of AT.

Sample Characteristics

  • N = 76
  • MEDIAN AGE = 50 years (range = 23–74 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Chemotherapy-naïve, female patients with breast cancer receiving doxorubicin and paclitaxel
  • OTHER KEY SAMPLE CHARACTERISTICS: 59.2% were age 50 or older and 40.8% were under age of 50; 51.3% of the women drank no alcohol and 48.7% reported drinking one or two glasses of wine per day.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Italy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

Phase II, nonrandomized, single-arm feasible study

Measurement Instruments/Methods

The Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 was given as a card to patients in order to grade the severity of nausea experienced. Patients also were asked to record emetic episodes and any antiemetic use.

Results

56 of 76 patients, or 74%, achieved overall complete control (CC, defined as no vomiting, no rescue anti-emetics, and no more than mild nausea) during the overall phase, days 1–5 of the first cycle of treatment. Specifically, 78% of patients achieved CC during the acute phase and 74% achieved CC during the delayed phase. All 76 patients were evaluable for efficacy in cycle 1. 13 of the 76 patients who entered cycle 1 did not continue the study due to antiemetic failure.
 
More than 80% of patients were vomiting-free during the overall phase, and more than 50% were nausea-free. Of the patients that continued on study for cycles 2 and 3, 70% and 66% achieved CC, respectively.

Conclusions

74% of the patients achieved CC in the first cycle, but there was a small reduction in CC as treatment continued to subsequent cycles. Authors even mentioned that delayed dexamethasone can be added in to the regimen if more optimal CINV control is needed. It is challenging to see the relevance of the proposed regimen if delayed dexamethasone would still be needed and steroids are still a part of the premeds, even if delayed dexamethasone is not required.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement validity/reliability questionable

Nursing Implications

Data have shown that dexamethasone can be decreased to day 1 only in combination with palonosetron with comparable nausea control. Data also have shown that CINV control with dexamethasone/palonosetron is superior than palonosetron as a single agent. Further investigation is required to determine if dexamethasone can be successfully replaced by other steroids in a premedication regimen.

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Damholdt, M.F., Mehlsen, M., O'Toole, M.S., Andreasen, R. ., Pedersen, A.D., & Zachariae, R. (2016). Web-based cognitive training for breast cancer survivors with cognitive complaints—A randomized controlled trial. Psycho-Oncology, 25, 1293–1300. 

Study Purpose

To investigate the use of a web-based cognitive training intervention for subjective and objective cognitive complaints in breast cancer survivors

Intervention Characteristics/Basic Study Process

HAPPYneuron Pro© (Scientific Brain Training, Villeurbanne Cedex, France) is a customized 12-task training program of 6 cognitive domains (attention, processing speed, learning, memory, working memory, problem solving) involving 10 levels of difficulty. The program required a minimum commitment of 30 minutes a day for 5 days a week for 6 weeks.

Sample Characteristics

  • N = 157   
  • MEAN AGE = 54.77 years (SD = 8.62)
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Recruited from existing cohort of 682 breast cancer survivors with subjective cognitive complaints and Internet access

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Aarhus University Hospital, Denmark

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Randomized, waitlist controlled, pretest–post-test design

Measurement Instruments/Methods

  • Paced Auditory Serial Addition Test (PASAT)-primary outcome working memory 
  • Cognitive Failures Questionnaire (CFQ)-secondary outcome perceived cognitive function
  • Neuropsychologic battery for other cognitive outcomes: Rey Auditory Verbal Learning Test (RAVLT) (verbal memory and learning), Digit Span Forward and Backward (working memory), letter fluency test
  • 20 Question Test, and cognitive estimation task (CET) (executive function)
  • Wechsler Adult Intelligence Scale (WAIS) (premorbid intelligence estimate)
  • Beck Depression Inventory (depression)
  • Whiteley-7 subscale from Common Mental Disorders Questionnaire (somatization, illness worrying, and conviction)
  • SCL-ANX4 from Symptoms Checklist-92 of the Common Mental Disorders–Screening Questionnaire (anxiety)
  • Likert-type scale rating of self-reported benefit from the intervention

Results

Web-based cognitive training did not improve function for the PASAT-measured domain of working memory or the CFQ-measured secondary outcome of perceived cognitive function. Improvement was demonstrated for cognitive function on two other neuropsychologic measures for verbal learning (RAVLT) (F [2, 272.1] = 3.2, p = 0.043) and working memory (digit span backward) (F [2, 272.6] = 3.3, p = 0.04).

Conclusions

Primary and secondary outcomes were not achieved, but web-based cognitive training was associated with improvement onone test of verbal learning and one test of working memory. Further study with instruments validated for phone administration may be warranted.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement validity/reliability questionable
  • Not all measures were validated for phone administration.
  • No webcam access to assure no cheating by participants

Nursing Implications

The web-based cognitive training intervention was well received by participants and not burdensome to administer in terms of costs. Small improvements were noted for some cognitive measures in the intervention group, and further study may be warranted.

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Dalton, J. A., Keefe, F. J., Carlson, J. & Youngblood, R. (2004). Tailoring cognitive-behavioral treatment for cancer pain. Pain Management Nursing, 5, 3–18.

Study Purpose

To determine whether a profile-tailored cognitive-behavioral therapy (CBT) treatment program was more effective than either standard CBT or usual care in changing outcomes for patients with cancer-related pain.

Intervention Characteristics/Basic Study Process

Patients received standard CBT, profile-tailored CBT, or usual care. Therapy group sessions ranged from 5 to 50 minutes.

Standard CBT is comprehensive CBT that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship among pain, suffering, and emotions; to use symptom-coping skills, problem solving, relaxation, and self control; and to modify cognitive distortions associated with emotional distress.

Profile-tailored CBT matches patients’ scores on the Biobehavioral Pain Profile (BPP) to specific CBT modules, environmental influences, loss of control, healthcare avoidance, past and current experience, physiologic responsivity, and thoughts of disease progression.

RNs received a two-day training course to deliver the intervention.

Sample Characteristics

  • The study was comprised of 131 patients who were experiencing cancer-related chronic pain for more than six weeks that was associated with disease progression, adjuvant therapy, or surgical exploration.
  • Mean patient age was 52 years.
  • Of the patients, 72% were female, 63% were Caucasian, and 35% were African American.
  • Patients had at least one elevated score on the BPP.
  • The most common diagnoses were lymphoma and breast, colon, and lung cancers.

 

Setting

The study was conducted at one inpatient and three outpatient cancer centers in the southeastern United States.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

 

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Brief Pain Inventory (BPI)
  • Profile of Mood States (POMS)
  • Karnofsky Performance Status Score (KPS)
  • Medical Outcomes Study–Short Form Health Survey (MOS-SF)
  • Katz Index of Independence in Activities of Daily Living (ADL)

Results

Short-term outcome:  Based on the BPI, interference with sleep improved from baseline to immediately postintervention for the profile-tailored CBT group.

Between-group comparison of the treatment effect over the entire study found treatment effects for interference of pain with mood and sleep. Response to the intervention decreased with time.

Limitations

  • Poor retention was noted, with only 28 patients completing the study.
  • The final sample size was very small.
  • Other concepts were measured, such as fatigue, pain, bowel patterns, symptom distress, quality of life (QOL), and better KPS.
  • RNs required a two-day training course to deliver the intervention.
  • Space is needed to provide the intervention.

 

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