Homsi, J., Walsh, D., Lasheen, W., Nelson, K.A., Rybicki, L.A., Bast, J., & LeGrand, S.B. (2010). A comparative study of 2 sustained-release morphine preparations for pain in advanced cancer. The American Journal of Hospice & Palliative Care, 27(2), 99–105.
To compare the efficacy, side effects, and use of rescue medication associated with two two-hour sustained-release morphine preparations: SR1 (MS Contin, Purdue Frederick Co., CN) and SR2 (Oramorph SR, Roxane Laboratories, Columbus, Ohio)
Patients' pain had been stabilized prior to treatment-group random assignment. Stabilization was defined as pain requiring fewer than four rescue doses in the previous 24 hours and pain rated as moderate or less for 48 consecutive hours. Patients were randomly assigned to SR1 or SR2 medication every 12 hours for five days. Investigators gathered data about side effects and compliance by means of daily telephone calls. Investigators assessed the acceptability of the medications at the end of the study, by asking patients if they wanted to continue taking the drug they were receiving.
Randomized open-label, parallel-group trial
Five-point rating scale (0 = none, 4 = severe), to measure pain
Authors noted an overall trend toward lower pain rating scores in the SR2 group. This difference was statistically significant (p = 0.05) on day 3 only. The total accumulative rescue dose over the study period was significantly higher for SR1 (p = 0.03). Authors noted no significant differences in side effects between the two groups. All patients taking SR2 elected to remain on that medication; 75% of patients preferred to continue taking SR1. Median morphine dose overall was higher in the SR1 group. The sample size was determined by power analysis.
The study suggests that, compared to SR1, SR2 may provide better analgesic efficacy, resulting in less overall need for rescue medication.
Findings suggest that the efficacy of various formulations of controlled- and sustained-release oral morphine preparations can be different. Nurses should be aware of this in the context of managing chronic pain. Researchers should undertake long-term studies to provide clinically relevant data in this regard.
Homsi, J., Nelson, K.A., Sarhill, N., Rybicki, L., LeGrand, S.B., Davis, M.P., & Walsh, D. (2001). A phase II study of methylphenidate for depression in advanced cancer. American Journal of Hospice and Palliative Care, 18, 403–407.
A phase II study of methylphenidate for depression in patients with advanced cancer
Patients who were identified as being depressed by a palliative medicine attending physician were treated with methylphenidate twice daily. Doses were titrated per regimen until response was obtained. Patients were assessed during a telephone call or bedside interview. The study timeframe was seven days.
Depression was resolved in all patients, most on day three. The maximum daily dose needed was 20 mg. Other symptoms also improved, mean pain scores significantly decreased, and all who responded to treatment were satisfied with therapy.
Holm, M., Arestedt, K., Carlander, I., Furst, C.J., Wengstrom, Y., Ohlen, J., & Alvariza, A. (2015). Short-term and long-term effects of a psycho-educational group intervention for family caregivers in palliative home care: Results from a randomized control trial. Psycho-Oncology. Advance online publication.
To measure the long- and short-term effects of a group family cancer caregiver psychoeducational intervention delivered in palliative home care settings on caregiver preparedness, health perception, anxiety, reward, burden, and depression
Study caregivers meeting inclusion criteria received random assignments to the psychoeducational or control group, which received standard care support. The former group participated in theoretically based, weekly afternoon group sessions delivered by an interdisciplinary team in a palliative care setting to increase caregiver preparedness for family member palliative care needs. Each session lasted two hours per week over a three-week period. The use of a session manual ensured consistent structure and content presentation to all groups. Content included patient symptom management, daily nutritional care, caregiver support, and existential issues related to family member diagnoses. Both control and intervention groups received standard care from patient palliative care settings. Data collection occurred for both groups at baseline, the end of the intervention, and two months after the intervention.
Randomized, unblided, controlled trial consistent with the Consolidated Standards of Reporting Trials
The study had 21 intervention sessions programs with an average of four caregivers per session. The mean age of the 175 patients in the study was 72 years, and greater than half of the sample was female and enrolled in Swedish palliative homecare for a median time of four months. In the first caregiver follow-up, the intervention group had significant increases in preparedness (p = 0.041) and caregiving competency (p = 0.001) from baseline as compared to control group (p = 0.041 by simple linear regression analysis). The second follow-up showed significantly higher intervention group scores on caregiver preparedness as compared to the control group (p = 0.12). No other significant findings for caregiving competency, rewards, burden, health, anxiety, or depression were found.
This study’s psychoeducational intervention showed significant improvements in caregivers’ preparedness in short- and long-term measurements and in caregivers’ perceived competency in the short-term. The nature of the intervention (three weeks) may have minimized significant effects on caregiver preparedness, competence, and rewards of caregiving compared to longer, previously published, six-session interventions that found such effects. No negative intervention effects occurred although other caregiver variables did not improve under investigation. Baseline data indicated that caregivers had low to moderate levels of burden, depression, and anxiety, and they had positive health perceptions that may have indicated that a short-term intervention would have a limited effect.
There is a need for diverse cultural randomized, controlled studies defining successful interventions that improve caregiver quality of life during palliative care. This Swedish study reflected high rates of caregiver attrition because of patient deaths or health deterioration. This suggests a critical need for innovative, personalized, short-term interdisciplinary healthcare interventions housed within the context of healthcare systems to meet caregiver needs.
Holmes, F.A., Jones, S.E., O'Shaughnessy, J., Vukelja, S., George, T., Savin, M., . . . Liang, B.C. (2002). Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: A multicenter dose-finding study in women with breast cancer. Annals of Oncology, 13, 903–909.
The purpose of the study was to investigate the efficacy, safety, and pharmacokinetics of various single doses of pegfilgrastim per chemotherapy cycle in women receiving chemotherapy with doxorubicin and docetaxel.
On day 2 of each chemotherapy cycle, 24 hours after chemotherapy completion, patients either received a single subcutaneous injection of pegfilgrastim or began daily injections of filgrastim for 14 days or until absolute neutrophil count (ANC) recovery to 10 x 109/L after nadir. Within the pegfilgrastim group, patients received 30, 60 or 100 mcg/kg. Filgastrim was given at 5 mcg/kg per day. Patients were randomly assigned to treatment group. Treatment was repeated for each cycle, up to four cycles. Blood samples were collected at screening, before each chemotherapy cycle, and once weekly during cycle 1. Findings were evaluated regarding duration of grade 4 neutropenia and rates of febrile neutropenia.
Multiple sites in the United States
Active antitumor treatment
Randomized dose finding phase II. Analysis also included open-label phase data.
Mean duration of grade 4 neutropenia in patients on filgastrim during cycle 1 was 2.5, and was 2.0 in patients receiving 30 mcg/kg pegfilgastrim (95% CI [0.35,1.93]). There was not a statistically significant difference in cycle 1 with the other pegfilgastrim dosage groups. Mean time to ANC recovery for cycle 1 was 9.4 days with filgastrim, 9.5 with 100 mcg pegfilgastrim (p = 0.05), 10.3 with 60 mcg (p = 0.05) pegfilgastrim, and 11 with 30 mcg doses (not significant). There were no significant differences across groups in any other outcome measure. There were no significant differences in adverse events. A single dose of pegilfrastim produced a sustained serum concentration, with maximum concentration at about 24 hours, and was sustained until ANC nadir.
Pegfilgastrim at a single dose per chemotherapy cycle was similar to daily filgastrim in efficacy and adverse effects.
Findings suggest that single dose of pegfilgastrim per chemotherapy cycle is similar to daily filgastrim dosing in terms of safety and efficacy. The need for fewer subcutaneous injections with single dosing may be beneficial to patients.
Holma, R., Hongisto, S.M., Saxelin, M., & Korpela, R. (2010). Constipation is relieved more by rye bread than wheat bread or laxatives without increased adverse gastrointestinal effects. Journal of Nutrition, 140, 534–541.
To investigate the effects of rye bread and cultured buttermilk on bowel function, colon metabolism, and gastrointestinal symptoms in adults with constipation.
For three weeks before the beginning of the study, participants were instructed not to use products containing Lactobacillus rhamnosus GG (LGG). At the end of the baseline period, participants were randomized into one of five groups.
Foods considered to have laxative effects (e.g., prunes, flax, fiber products) were only allowed for the laxative group. All participants were permitted laxative use as necessary after first contacting the principal investigator. Participants were to exclude products containing other lactic acid bacteria.
Participants collected all feces for five days during the baseline week, one day during week 1, and five days during week 3. The samples were kept frozen until taken to the study center. Sitzmarks® Radiopaque capsules were used to determine total intestinal transit time (TITT) measurements.
A metropolitan area in Helsinki, Finland
This study had a randomized, unblended, 2 x 2 factorial design (LGG given, LGG not given, rye bread given, rye bread not given).
Patients self-reported the following.
In adults with constipation, bowel function and colonic metabolism may improve more with rye bread consumption than with wheat bread consumption or common laxative use without causing adverse abdominal symptoms. Cultured buttermilk with LGG did not significantly improve bowel function or affect colonic metabolism in this population.
Rye bread consumption may be more effective in relieving constipation than wheat bread or commonly used laxatives in adults. However, the convenience sample of volunteers was small, comprised predominately men, and did not include patients with cancer. Additional study is warranted in a larger population that includes patients with cancer, as well as a balanced number of women and men.
Holland, J.C., Morrow, G., Schmale, A., Derogatis, L., Stefanek, M., Berenson, S., . . . Feldstein, M. (1991). A randomized clinical trial of alprazolam versus progressive muscle relaxation in cancer patients with anxiety and depressive symptoms. Journal of Clinical Oncology, 9, 1004–1011.
The 10-day study had two arms: alprazolam 0.5 mg three times a day or progressive muscle relaxation three times a day.
A randomized controlled trial (nonblinded) design was used.
There was significant decrease in anxiety (HARS, ABS, SCL-90 subscale) and depression (SCL-90 subscale) in both treatment arms (p < 0.001). There was minimal change in pulse and blood pressure.
Hökkä, M., Kaakinen, P., & Pölkki, T. (2014). A systematic review: Non-pharmacological interventions in treating pain in patients with advanced cancer. Journal of Advanced Nursing, 70, 1954–1969.
PHASE OF CARE: End of life care
APPLICATIONS: Palliative care
Interventions included massage or aromatherapy massage (five studies), physical therapy and massage (one study), transcutaneous electrical nerve stimulation (TENS, one study), acupuncture (one study), reflexology (one study), warm water footbath (one study), biofeedback-assisted relaxation (one study), and varied strategies of relaxation and imagery with nature sounds (one study). The effectiveness of massage was mixed, TENS had the potential to reduce pain on movement, acupuncture reduced pain immediately after the intervention but the benefit was transient, reflexology showed no effect, relaxation with biofeedback was beneficial, and psychoeducational and behavior strategies had only a short-term effect. Most studies were found to have a relatively high risk of bias.
There was insufficient evidence to draw firm conclusions about the effectiveness of nonpharmacologic interventions to reduce pain among patients with advanced cancer.
Treating pain is a high priority among patients with advanced cancer receiving palliative care. The effectiveness of many nonpharmacologic interventions is unclear and warrants additional well-designed research. Most of the evidence involved studies in inpatient settings. Additional research among outpatients and those receiving palliative care in the home is needed. Nonpharmacologic interventions are generally low-risk. The identification of approaches than can facilitate reductions in pain would be beneficial for patients with cancer-related pain.
Hogan, R. (2009). Implementation of an oral care protocol and its effects on oral mucositis. Journal of Pediatric Oncology Nursing, 26, 125–135.
To review current knowledge and provide guidance to clinicians regarding care for the prevention of mucositis, particularly pediatric patients
The databases searched and search keywords were not stated.
This study has clinical applicability to pediatrics.
Experts generally agree that oral care is important and that oral care instructions should include brushing teeth 2–3 times per day, flossing, rinsing with a bland agent such as sterile water, using fluoride therapy, and using mouth moisturizers. These measures are recommended regardless of hematologic status. Experts recommend changing toothbrushes frequently. Dental assessments should be performed at initial diagnosis. This report provides a summary of the oral care guidelines of four organizations.
This report provides general recommendations for oral hygiene but no specific review of evidence or evidence quality.
This report provides a general overview and supports the development and implementation of specific protocols based on evidence for oral care.
Hofmann, S.G., Sawyer, A.T., Witt, A.A., & Oh, D. (2010). The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. Journal of Consulting and Clinical Psychology, 78, 169–183.
To provide a quantitative, meta-analytic review of the efficacy of mindfulness-based therapy (MBT) for improving anxiety and mood symptoms in clinical populations
MBT was moderately effective for improving anxiety (Hedges’s g = 0.63) and mood symptoms (Hedges’s g = 0.59) from pre- to post-treatment in the overall sample. Eight studies met criteria for elevated levels of depression symptoms at pretreatment; none of these involved patients with cancer.
The effects of MBT on depression and anxiety related to chronic conditions, such as cancer, might be smaller than expected, because patients may experience physical symptoms listed on depression or anxiety scales as a result of their physical condition or as a side effect of medical treatment.
MBT is a promising intervention in the treatment of anxiety and mood problems in patients with medical diagnoses, including cancer.
Hoffman, A.J., Brintnall, R.A., Given, B.A., von Eye, A., Jones, L.W., & Brown, J.K. (2016). Using perceived self-efficacy to improve fatigue and fatigability in postsurgical lung cancer patients: A pilot randomized controlled trial. Cancer Nursing, 40, 1–12.
To design and test the feasibility and acceptability of a postsurgical intervention with exercise for patients with non-small cell lung cancer to promote perceived self-efficacy for fatigue self-management targeting cancer-related fatigue (CRF) severity and its associated fatigability
Participants performed warm-up exercises designed for the patient population. Wii walking was self-paced and comfortable for participants with the Wii exercise equipment, creating a virtual environment in a town of happy people providing encouragement to continue. Patients started walking five minutes each day for five days during week 1 and increased by five-minute intervals per day until a goal of 30 minutes per day of Wii walking was reached by week 6. The nurse assessed each participant’s readiness to advance the walking prescription. Participants also completed balance exercises five days a week from weeks 1 to 6 from a menu of predetermined Wii balance exercises, which used a gaming format. Data were recorded in the participants' daily diaries and confirmed by research staff as recorded in the Wii Fit Plus.
Two-arm, randomized, controlled trial to compare the impact of a six-week rehabilitative CRF self-management exercise intervention post-surgical hospital discharge. The control group used a Wii-based walking and balance home program at home.
Feasibility: Rates of recruitment, adherence, retention, and monitoring of adverse events
Acceptability: 15-item acceptability questionnaire developed by the researchers
Efficacy:
Functional status:
Feasibility and acceptability: Recruitment, vulnerable population, adherence, and acceptability goals were exceeded. No adverse events were reported.
Efficacy: At week 6, interval scores for CRF, CRF self-management, walking, balance, and fatigability were significantly different (p < 0.001) between the intervention group and control group. Participants exceeded minimum walking-balance exercise behaviors during the six-week study period. Functional performance decreased postsurgery in both the control and intervention groups. Improvement occurred in weeks 1–6 for both groups but improved more slowly in the control group versus the intervention group.
A home- and Wii-based exercise and balance program for patients with lung cancer postsurgery is a feasible, acceptable, safe, and effective method to improve fatigue and fatigability in this patient population.
Early rehabilitation exercise and balance interventions for patients undergoing surgery for non-small cell lung cancer are feasible, acceptable, and safe. Additional research is needed to determine factors to enhance adherence to exercise and balance interventions beyond the immediate postsurgical period (six weeks) and to determine their effects on prognosis and functional (physical and mental) capacity.