Berger, A. M., Kuhn, B. R., Farr, L. A., Von Essen, S. G., Chamberlain, J., Lynch, J. C., & Agrawal, S. (2009). One-year outcomes of a behavioral therapy intervention trial on sleep quality and cancer-related fatigue. Journal of Clinical Oncology, 27, 6033–6040.
To determine the effects of a behavioral therapy (BT) sleep intervention (individualized sleep promotion plan [ISPP]) on cancer-related fatigue over a one-year period in women receiving adjuvant chemotherapy for breast cancer.
Patients at each study site were stratified according to number of planned anthracycline-based treatments and good versus poor sleep quality. Patients were then randomly assigned to the ISPP group or a control group that received care regarding health eating (HEC), which received the same amount of individual time and attention as the ISPP group. At baseline, patients in the ISPP group spent 90 minutes with the research nurse to develop a 12-item ISPP plan. Two days before all treatments, they spent another 30 minutes with the research nurse revising the plan based on sleep diaries and plan adherence data. After each revision, plans were reinforced in a 15-minute, in-person session seven to nine days after the revision. Plans included
Thirty-minute sessions were held to revise the BT plan again at 30, 60, and 90 days after the last chemotherapy treatment. HEC participants received in-person sessions of equal time and attention before each treatment and at 30, 60, and 90 days after the completion of chemotherapy.
This was a randomized, controlled trial with a one-year follow-up.
The BT group had a significant improvement in sleep quality compared to the HEC group at 90 days (p = 0.002) but not at one year (p = 0.052). Higher fatigue (p = 0.027) and higher anxiety (p = 0.012) at baseline were associated with poorer sleep at one year. There were no differences in most diary and objective sleep findings at selected times over the year. Sleep diary and actigraph findings did not coincide for either group. Values recorded in the diaries tended to show better sleep time and percent and lower numbers of awakenings than the actigraph findings. Moderate to severe fatigue was reported at one year by 20% of patients in the BT group and 24% in the HEC group. Fatigue changed over time for both groups, but there were no significant differences between the groups. PSQI scores over time were significantly better in the BT group (p = 0.013).
The BT intervention improved global sleep quality but did not improve fatigue in women over a period of one year. Baseline anxiety was associated with higher fatigue and poor sleep at one year.
Berger, A. M., Kuhn, B. R., Farr, L. A., Lynch, J. C., Agrawal, S., Chamberlain, J., & Von Essen, S. G. (2009). Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psycho-Oncology, 18, 634–646.
To determine the effect of behavioral therapy (BT)—specifically, an individualized sleep promotion plan (ISPP)—on sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy.
Eligible women who consented to participate were randomized using stratified random sampling to either the BT group or to a healthy eating control (HEC) group prior to adjuvant chemotherapy. Patients completed questionnaires at baseline and wore a wrist actigraph for two days prior to initial treatment. Patients randomized to the BT group developed an ISPP during individual visits with the research nurse two days prior to treatment. Modifications to this plan were made two days prior to each treatment and 30 days after the last treatment. Modifications were based on patients' sleep diary data and treatment adherence. BT plans were reinforced during 15-minute sessions seven days after each revision. Patients in the HEC group received equal time and attention during individual visits and received information on healthy eating topics at each visit. Patients in the HEC group were referred to their treatment clinic for questions about fatigue and sleep.
The study was conducted in 12 oncology clinics in the Midwestern United States.
Patients were undergoing the active treatment phase of care.
This was a randomized, controlled trial.
Mean PSQI scores in both groups were greater than five, which indicated poor sleep compared to the general population; however, mean scores were not greater than eight, a cutoff score associated with poor sleep quality in patients with breast cancer. Actigraphy and diary data showed normal sleep duration and sleep efficiency in both groups across treatment and follow-up. Number of awakenings after sleep onset measured by both sleep diaries and actigraphy were higher than normal in both groups. Significant differences between sleep diaries and actigraphy were observed for all sleep variables (p < 0.01 for all variables), with lower numbers of awakenings and higher sleep efficiency per diary data in the BT group. A significant group by time interaction was found for changes in the PSQI, with sleep quality improving in the BT group (p < 0.049). Although not significant, there were trends towards improved sleep quality over time in the BT group per actigraphy for total sleep time and number of awakening and per sleep diary for sleep efficiency. Perceived fatigue changed significantly over time in both groups (p < 0.001), with increased fatigue during treatments and decreased fatigue after the end of treatments in both groups. There was no apparent effect of BT on fatigue levels.
Patients in the BT group showed greater improvement in sleep quality over time than those in the the HEC group, although perceptions of improved sleep quality were not consistently associated with objective sleep measures, sleep diaries, or reported fatigue. BT was not shown to have an effect on fatigue.
BT may be used by trained nurses to improve sleep quality in patients with breast cancer receiving adjuvant chemotherapy. Further research is needed to determine the long-term effects of BT on sleep quality and fatigue in this population.
Berger, A. M., VonEssen, S., Kuhn, B. R., Piper, B. F., Agrawal, S., Lynch, J. C., . . . Higginbotham, P. (2003). Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. Oncology Nursing Forum, 30, 513–522.
To evaluate the outcomes of an intervention designed to promote sleep and modify fatigue after adjuvant breast cancer chemotherapy.
A multicomponent cognitive-behavioral therapy in the form of a four-part intervention consisting of sleep hygiene counseling, relaxation therapy, sleep restriction, and an individualized sleep promotion plan (ISPP) stimulus control was used. It started two days before the first chemotherapy treatment; continued during treatment; was revised 30, 60, and 90 days after the last treatment; and was reinforced seven days later. Sleep and fatigue were the outcomes measured.
The study was conducted in the Midwestern United States in the patients’ homes.
Patients were undergoing the long-term follow-up phase of care.
This was a prospective, repeated measures, quasiexperimental feasibility study.
High adherence to the four components of the ISPP was found, except for stimulus control. Sleep latency remained stable. Sleep efficiency ranged from 82% to 92%, and total rest ranged from seven to eight hours per night. The number of night awakenings ranged from 10 to 11 per night.
Berger, A. M., VonEssen, S., Kuhn, B. R., Piper, B. F., Farr, L., Agrawal, S., & ... Higginbotham, P. (2002). Feasibilty of a sleep intervention during adjuvant breast cancer chemotherapy. Oncology Nursing Forum, 29, 1431–1441.
To evaluate the feasibility of an intervention designed to promote sleep and modify fatigue during four cycles of adjuvant breast cancer chemotherapy.
A multicomponent cognitive-behavioral therapy in the form of a four-part intervention consisting of sleep hygiene counseling, relaxation therapy, sleep restriction, and an individualized sleep promotion plan (ISPP) stimulus control was used. It began two days before the first chemotherapy treatment, was revised before each treatment, and was reinforced seven days after each treatment. Restrictions were delivered by RNs. Sleep and fatigue were the outcomes measured.
The study was conducted in the Midwestern United States, in urban oncology clinics and the patients’ homes.
Patients were undergoing the active treatment phase of care.
This was a prospective, repeated measures, quasiexperimental, feasibility study.
Sleep latency, sleep efficiency, total rest, and ratings of feeling refreshed on awakening were stable. Time awake after sleep onset and nighttime awakenings exceeded desired levels.
Berger, A. M., VonEssen, S., Kuhn, B. R., Piper, B. F., Agrawal, S., Lynch, J. C., & Higginbotham, P. (2003). Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. Oncology Nursing Forum, 30, 513–522.
Patients received a multi-component, cognitive-behavioral therapy (CBT), individual sleep promotion plan (ISPP) that included
The ISPP started two days before the first prescription; continued during chemotherapy prescription; was revised 30, 60, and 90 days after the last prescription; and was reinforced seven days later. There were three doses and reinforcements.
Patients were undergoing the long-term follow-up phase of care.
This was a prospective, repeated measures, feasibility study with a single group and no control.
Adherence to the intervention was high except for stimulus control. Fatigue scores were not significantly different over time.
Berger, A. M., VonEssen, S., Khun, B. R., Piper, B. F., Farr, L., Agrawal, S., . . . & Higginbotham, P. (2002). Feasibility of a sleep intervention during adjuvant breast cancer chemotherapy. Oncology Nursing Forum, 29, 1431–1441.
Patients received multicomponent cognitive-behavioral therapy (CBT). Individual sleep promotion plans (ISPPs) included
Each plan started two days before the first prescription, was revised before each prescription, and was and reinforced seven days after each prescription. There were four doses and reinforcements.
Patients were undergoing the active treatment phase of care.
This was a prospective, repeated measures, feasibility study with a single group and no control.
Berger, A. M., Kuhn, B. R., Farr, L. A., Lynch, J. C., Agrawal, S., Chamberlain, J., & Von Essen, S. G. (2009). Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psycho-oncology, 18, 634–646.
To determine the effectiveness of a behavioral therapy (BT) intervention, an individualized sleep promotion plan (ISPP), on sleep quality and fatigue in women with breast cancer receiving adjuvant chemotherapy.
Participants were recruited and screened for eligibility between 2003 and 2006. Eligible women interested in participation were visited by a research nurse who completed the randomization procedure, administered baseline questionnaires, and had patients wear an actigraph two days prior to the initial treatment. The intervention was delivered by research nurses who were trained by a sleep psychologist.
Those assigned to the BT group developed a 120-item ISPP with the research nurse according to the nurse's review of responses to measures to identify areas of sleep difficulty. Advice and information was tailored to individual needs. Revisions to the ISPP were made in 30-minute appointments made with participants two days prior to each treatment and 30 days after the last treatment. Reinforcement of the plan was made in 15-minute appointments seven days after each revision. Each ISPP included
Patients in the control group received equal time and attention at each home visit and were provided with general support and a discussion of a new healthy eating topic.
Multisite
This was a randomized, controlled study.
Baseline sleep quality measures indicated mild fatigue, somewhat poor sleep quality, low levels of symptom distress, and normal anxiety and depression levels. PSQI scores indicated lower sleep quality than the general adult population but better scores than those previously associated with poor sleep quality in patients with breast cancer. There were significant differences over time on all sleep variables from the diaries and actigraphs (p < 0.01). Diaries showed a significantly lower number of awakenings (p = 0.032), a lower average amount of time awake while in bed (p = 0.027), and higher sleep efficiency (p = 0.001) in the BT group. Fatigue scores in both groups increased during treatment and decreased after treatment ended (p < 0.0001). This pattern was similar in both study groups. Perceived fatigue was similar between the two groups. There was a trend of improved sleep quality over time (PSQI) in the BT group.
The four-component ISPP was associated with improved sleep quality over time, better sleep efficiency, and fewer awakenings. Findings suggested that perceptions of improved sleep quality were not consistently associated with diary entries or objective sleep measures.
Berenstein, E.G., & Ortiz, Z. (2005). Megestrol acetate for the treatment of anorexia-cachexia syndrome. Cochrane Database of Systematic Reviews, 2, CD004310.
To evaluate the efficacy and safety of megestrol acetate (MA) in palliating anorexia-cachexia syndrome in patients with cancer, AIDS, or other underlying pathologies
Studies that met the following eligibility criteria were reviewed.
Data extraction was conducted by two independent authors. Methodological quality was assessed using the Oxford scale (Jadad, 1996). Scores for methodological quality were generally high. Studies in which more that 50% of patients were lost to follow-up were excluded from the analysis.
Results for MA versus placebo: In patients with cancer, a statistically significant improvement in appetite was observed in the patients treated with MA. Weight gain also was observed in this group.
Results for MA versus other drugs: MA did not show benefits in terms of appetite improvement in comparison to other drugs. Significant differences in quality of life were not reported.
Results for different dose levels of MA: Using 400–800 mg as a cutoff and comparing high to low doses, significant differences in appetite outcomes could not be appreciated.
MA improves appetite and weight gain in patients with cancer. Due to study heterogeneity, no overall conclusion can be drawn about its impact on quality of life; a more systematic approach was suggested for the measurement of quality of life in the trials. The clinical effects of MA do not appear to be dose-related, and the mechanism by which MA increases weight gain is unknown.
MA cannot be recommended for use in patients with AIDS or anorexia-cachexia related to other pathologies. Edema, included in the adverse event profile of MA, is the only significant difference between the treatment and a placebo.
Berenson, J.R., Yellin, O., Shamasunder, H.K., Chen, C.S., Charu, V., Woliver, T.B., . . . Vescio, R. (2014). A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma. Supportive Care in Cancer. Advance online publication.
To study effects of armodafinil on cancer-related fatigue in patients with multiple myeloma
Patients were randomly assigned to study groups in this crossover design study. One group was a treatment-only arm that got armodafinil, and the other was a placebo-first arm that received a placebo followed by armodafinil. Patients received armodafinil 150 mg once daily for 56 days in the treatment-only group. In the other group, patients received a placebo for 28 days and armodafinil on days 29–56. Assessments were done at baseline and at days 15, 28, 43, and 56. Five variations of study assessments were used to address potential memorization effects, and the order in which versions were used was varied.
Double-blind, randomized, crossover-controlled trial
Adverse effects observed during armodafinil treatment were similar between groups. Fatigue as measured by the BFI scale decreased significantly for both groups over time with no difference between groups. Outcomes measured by FACIT scores increased significantly in the placebo-first group by day 28, and FACIT fatigue scores improved significantly in both groups. Anxiety decreased significantly from baseline in both groups. Depression scores only declined significantly in the placebo-first group by day 28. Degree of sleepiness decreased significantly in the placebo group. There were no significant changes in study measures between day 28 and day 56 in which all patients received armodafinil.
Armodafinil was not shown to significantly improve symptoms of fatigue, anxiety, or depression in patients with multiple myeloma.
Armodafinil, a medication similar to modafinil, was not shown to be effective for the reduction of fatigue, anxiety, or depression.
Benson, A.B., Ajani, J.A., Catalano, R.B., Engelking, C., Kornblau, S.M., Martenson, J.A., . . . Wadler, S. (2004). Recommended guidelines for the treatment of cancer treatment-induced diarrhea. Journal of Clinical Oncology, 22, 2918–2926.
The type of evidence found was based on review of the literature and clinical expertise.
The panel focused mainly on colorectal cancer and patients receiving chemotherapy with FU and CPT-11 or radiation therapy, so this is not applicable to other populations (i.e., transplant population).
Diarrhea is a challenge for patients receiving chemotherapy and/or radiation therapy for their cancer. Through in-depth gastrointestinal assessments and optimal treatment, nurses are able to minimize the potential for increased toxicities associated with chemotherapy-induced diarrhea.