To test the proof of concept for a web-based intervention for fatigue designed to enhance self-efficacy in the management of cancer-related fatigue to inform the design of an effectiveness trial

This study was a multi-center, parallel-group, two-armed (1:1), exploratory, randomized (RESTORE or written leaflet), controlled trial with qualitative process evaluation. Patients were randomly assigned to receive an informational leaflet or participate in the use of a web-based program. The web-based program consisted of five sessions, including mandatory sessions on fatigue and goal setting and four other sessions that patients could choose from, that were presented to the patient at weekly intervals. The program also included videos of patient stories and automated tailored feedback components.

• N = 118 in trial, 159 in ITT
• AGE: 29–80 years
• MALES: 23.3%, FEMALES: 76.7%
• KEY DISEASE CHARACTERISTICS: Invasive cancer diagnosed five or less years prior to study, no evidence of metastatic disease, completed curative-intent cancer treatment 
• OTHER KEY SAMPLE CHARACTERISTICS: Self-reported moderate-to-severe fatigue, access to the Internet, had or were willing to establish an email account

• SITE: Multi-site  (N = 12)  
• SETTING TYPE: Not specified  
• LOCATION: United Kingdom sites

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care

• Parallel group, two-armed (1:1), exploratory, randomized, controlled trial

• Fatigue self-efficacy
• Cancer survivor self-efficacy (Confidence in performing disease-related care activities)
• Brief Fatigue Inventory (BFI)
• Personal Wellbeing Index (PWI) (Satisfaction with life)
• Functional Assessment of Cancer Therapy-General (FACT–G) (Physical, social, emotional, and functional well-being)
• Patient Health Questionnaire-9 (PHQ-9) (Depression screen) 

FEASIBILITY: Forty-one percent of eligible patients consented to the study (16% of screened patients). The randomization process resulted in generally balanced groups with the exception of “not working” and “days since last cytotoxic treatment.” ACCEPTABILITY: Fifty percent indicated that the timing of program delivery was “about right”; others would have preferred earlier. Participants reported feeling supported and reassured that someone was interested in their fatigue. The attrition rate from consent to T2 was 36%. Seventy-one percent of participants determined to have adhered to intervention (completed sessions 1 and 2 and one of the remaining three sessions). No significant differences in symptoms or self-efficacy existed between groups.

Web-based resource (RESTORE) for the enhancement of self-efficacy in the management of cancer-related fatigue, pending recommended revisions, may be feasible and acceptable for use in research studies. Further study is needed to determine effectiveness.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Dropout rate in RESTORE group was significant, and the significance of missing data limits the study.

Nursing implications include the cautious use of feasibility, acceptability, and adherence data for the completion of a web-based program to enhance self-efficacy in the management of cancer-related fatigue based on responses from multi-site participants in the United Kingdom.

To identify predictive factors of response to decongestant treatment through univariate and multivariate analysis

Patients received complex decongestive treatment with manual lymphatic drainage (45 minutes) and pressotherapy with pneumatic multichambered device between 50 and 80 mm Hg (30 minutes). Treatment also included wearing a multilayered bandage until the next day. Sessions were performed consecutive days until a plateau in reduction was reached, which was normally between 10–20 sessions. Compliance with bandages was measured.

• The study sample (N = 171) was comprised of patients with breast cancer who had lymphedema.
• Median age was 60.4 years, with a range of 32–84 years.
• Patients were included in the study if they were 18 years of age or older, were free from malignant disease, and had no decongestant treatment for your year.

The study took place across multiple sites in Spain.

The study used a prospective, multicenter controlled cohort design.

• Factors associated with response were testing in a univariate and multivariate analysis using linear regression.
• Hypothesis testing was two-tailed with a 5% level of significance.
• Analyses were made with SPSS version 15.

Eleven variables were retained after initial screening. Venous insufficiency, treatment in autumn, and compliance were associated with better outcome while higher baseline excess volume and percentage reduction, heaviness, numbness, chemotherapy, axillary radiation, total dose of radiation, and treatment in winter were associated with poorer outcome.

The most important predictor of response to treatment was compliance. Early intervention is key.

• The descriptive analysis is only to identify potential risk factors.

Patient education and support to promote early intervention and patient compliance with treatment may have a positive effect in response to lymphedema treatment

To compare, after open nephrectomy, the efficacy of continuous wound site infusion with ropivacaine with that of saline; to examine morphine consumption, side effects, bowel function, and hospital length of stay in two study arms

Patients received continuous surgical wound site infusion of either 0.5% ropivacaine or 0.9% saline. For breakthrough pain, all patients received standard care with PCA morphine and ketorolac.

• The sample was composed of 168 patients.
• The age range of patients was 47–71 years. In the ropivacaine group, the mean age was 58.7 years. In the saline group, the mean age was 60.2 years.
• Of all patients, 61% were females and 38.1% were males.
• During the study all patients underwent open nephrectomy through lumbotomic access. Authors did not report underlying diagnoses.

• Single site
• Inpatient
• Rome, Italy

Prospective randomized, double-blinded, placebo-controlled study

• Visual analog scale, 0–10 score, to measure incident pain at mobilization
• Consumption of PCA morphine
• Time to bowel recovery
• Level of sedation
• Length of hospital stay

• Pain at rest and while coughing was significantly less (p < 0.0001) in the ropivacaine group than in the control group.
• Morphine consumption was significantly greater in the control group than in the ropivacaine group. Mean total morphine consumption was significantly greater in the control group (p < 0.0001).
• Compared to the control group, time to bowel recovery was significantly shorter and sedation was less in the ropivacaine group (p < 0.0001).
• Time to discharge was 3.2 days in the control group versus 2.1 days in the ropivacaine group (p < 0.001).
• Use of ropivacaine resulted in substantial cost savings per patient, primarily because ropivacaine was associated with shorter length of stay.

Continuous wound infusion with ropivacaine improved pain relief and accelerated recovery and discharge.

A single surgeon peformed all procedures and placed all catheters. Because of the various locations of nociceptive receptors, this makes generalizing study findings questionable; placement of catheters for local infusion relates to results.

Multimodal pain management that includes continuous wound infusion of anesthetic and systemic opioid can reduce postoperative pain, thereby reducing length of stay and hospitalization costs.

To investigate the effects of qigong exercises on upper extremity lymphedema, arterial resistance, and blood flow velocity in breast cancer survivors

Experimental group performed approximately six minutes of the 18 forms tai chi qigong exercises, and the control group rested.

• N = 23
• MEAN AGE = 58 years (intervention), 54 years (control)
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Females older than age 18, treated with mastectomy, lymphedema of greater than 2 cm circumferential measurement in affected versus unaffected extremity, no known neurological deficits
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusions included current adjuvant treatment, recurrence of disease, lumpectomy, pregnancy, or performing other regular exercise.

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Hong Kong

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care

• Pilot, single-blind, nonrandomized, controlled trial

• Circumferential limb volume
• Tape measurement
• Doppler for arterial resistance
• Resistance Index

There was an immediate circumferential decrease and blood flow resistance decrease, with increase in blood flow velocity in the experimental group. However, no girth changes between groups may indicate only temporary effects.

More rigorous randomized, controlled studies are needed to confirm the effects of this exercise.

• Small sample (< 30)
• Risk of bias (no random assignment)
• Findings not generalizable

Nurses should encourage limb movement and range of motion exercises for breast cancer survivors.

STUDY PURPOSE: To evaluate the evidence regarding the effects of physical activity in cancer survivors

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 54 in qualitative review and 34 in meta-analysis
• SAMPLE RANGE ACROSS STUDIES: Median sample size was 93 patients
• KEY SAMPLE CHARACTERISTICS: Various tumor types with the most common being breast, colorectal, and endometrial; mean age was 55 years (range = 39–74 years)

PHASE OF CARE: Late effects and survivorship

The median duration of the exercise intervention was 13 weeks (range = 3–60). A meta-analysis of results for body mass index, body weight, and other physiologic measures was reported. A meta-analysis was completed for three studies regarding effect on fatigue, and slightly reduced fatigue was demonstrated using the Piper Fatigue Scale (p = 0.03). However, sample sizes were small in these studies. A meta-analysis of effects on depression included four studies and showed reduced depression using the Beck Depression Inventory (p < 0.01). Three of the four studies had relatively small sample sizes. Quality of life outcomes showed improved Short Form-36 physical functioning scores (p = 0.01) and mental health scores (p = 0.01). The authors noted substantially different results based on the measurement scales used in the included studies.

This analysis supports the effectiveness of exercise in general on cancer-related fatigue and depression.

It was suggested that the intensity of the exercise could affect results, and intensity was not consistently reported in the studies included. The mean duration of the intervention was as high as 13 weeks and as low as three weeks. The relatively short duration limits the ability to assess long-term outcomes. Most studies were completed in patients with breast cancer. There were very few studies in the analysis, and it was surprising that more studies were not found for inclusion. The studies of fatigue and depression included in this meta-analysis had relatively small sample sizes.

This report adds to the already large body of evidence demonstrating that exercise can improve fatigue and depression outcomes in cancer survivors. Current evidence, however, involves relatively short-term interventions and assessments. For long-term benefits, it is generally believed that physical activity needs to be incorporated into everyday life. Nursing interventions and future research should consider the examination of approaches to address this need for ongoing behavior change. Most exercise studies continue to involve women with breast cancer. Although there is some evidence in other groups, it is limited. Continued research to examine exercise's effects in more varied patients would be beneficial.

• FINAL NUMBER STUDIES INCLUDED = 15
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,077
• KEY SAMPLE CHARACTERISTICS: Six studies addressed RE during treatment, and four were conducted during androgen deprivation therapy, one during chemotherapy, and two during radiation therapy. The remaining nine studies focused on RE in participants following the completion of active cancer treatment with a curative intent. This included participants with BRCA (n = 6), prostate cancer (n = 4), head and neck cancer (n = 3), lung cancer (n = 1), and a mixed group (n = 1).

Pertaining to fatigue outcomes, two randomized, controlled design studies showed insignificant changes in fatigue with BRCA survivors. One nonrandomized trial showed insignificant change in patients with prostate cancer. Two randomized, controlled studies showed moderate to large effect sizes in patients with BRCA and prostate cancer patients over time after three and six months. Large effects were seen in the Schmidt study with BRCA survivors. A moderate effect was seen in the Segal study of patients with prostate cancer receiving androgen deprivation therapy. Small effect sizes were seen in BRCA patients undergoing chemotherapy at a midpoint and post-treatment.

The results of this study suggested that RE may improve fatigue in patients with BRCA undergoing chemotherapy, patients with prostate cancer undergoing androgen deprivation therapy, and in BRCA survivors.

Although methodologic quality was good overall, an increase of intent-to-treat analyses of future randomized, controlled trials is needed.

Few studies examined this type of exercise, and additional study is indicated.

The intervention included twelve 90-minute meetings of a supportive-expressive group therapy led by a licensed clinical social worker; participants discussed problems, coping, treatment, mood, self-efficacy, relationships, pain, sleep, body image, and sexuality. Outcomes were emotional distress, mood, self-efficacy, body image, sexuality, social support, quality of life (QOL), pain, and sleep.

• The sample comprised 20 patients with stage I to IIIA breast cancer.
• Mean age was 47 years.
• Patients were post surgery.

Three community settings in Northern California

Patients were undergoing the active treatment phase of care.

The study used a one-group, pre-/posttest design.

Brief questionnaire based on the Structured Insomnia Interview to assess quality and quantity of sleep and daytime sleepiness

Patients undergoing 12 weeks of supportive group therapy showed statistically significant improvement in sleep (less waking during the night).

• The study had a small sample size and lacked a control group.
• Training is required to observe for unstable emotional status.
• A licensed clinical social worker familiar with supportive-expressive group therapy is needed.
• Cost is incurred for a space for the class and the instructor.

To evaluate the effectiveness of concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) in improving symptoms of xerosis in patients receiving chemotherapy.

• The study reported on a sample of 30 adult patients.
• Patients had gastrointestinal, breast, prostate, and lung cancers, and lymphoma; were receiving chemotherapy; and were experiencing dry, sensitive skin.

This study was conducted at Friedrich-Schiller University in Jena, Germany, and at Istituto Dermatologico San Gallicano in Rome, Italy.

This was a controlled, monocentric, three-week treatment trial.

• Patients were assessed on days 0, 7, 14, and 21 with four electronic devices.
  • Skin pH-Meter^® PH 900 to assess skin pH
  • Tewameter^® TM 300 to measure transepidermal water loss (TEWL)
  • Corneometer^® CM 825 to measure capecitabine-based skin hydration
  • Sebumeter^® SM 815 to measure casual surface sebum content
• Physician clinical assessment included the following.
  • Estimation of dryness symptoms with an original scale from 0 to 4
  • Visual assessment of perceived skin change with a 10-point scale
  • Physicians and patients gave subjective assessment on a questionnaire about the tolerability of both products.

• A significant reduction in TEWL (p < 0.007) was noted over time on the treated forearm.
• Compared to baseline, sebum content hydration values increased significantly until the end of the study (p < 0.001).
• Casual skin surface lipids increased significantly on the treated forearm (p < 0.03).
• No significant difference existed in pH values on both the treated and untreated forearms.
• For the physicians' clinical assessment, a progressive improvement of all skin symptoms was recorded in the course of treatment, whereas the lowest values (e.g., the best results) were obtained on the last examination day (p < 0.001).
• The visual assessment of the perceived change in skin state showed a significant improvement over the course of the study.
• Both the physicians and patients considered the application of the treatment tolerable enough with a good cleansing effect, leaving a nice sensation after use.

Concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) was effective in improving symptoms of xerosis in patients receiving chemotherapy.

• The study was not randomized or double blinded.
• The study was funded by Sebapharma, whose products were used.

The purpose of the study was to compare the use of pegfilgratim in all chemotherapy cycles with pegfilgrastim use at the clinician’s discretion for the reduction of febrile neutropenia, grade 3 or 4 neutropenia, dose delay, dose reduction, hospitalization, antibiotic use, and infections in older adults with cancer.

Study period was June 2002 to Nov 2004.

Older adults with cancer of the breast, ovary, lung, or aggressive non-Hodgkin lymphoma (NHL) were randomized to pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring with cycle one) or secondary prophylaxis with pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring after cycle one at physician’s discretion [discretion may be in response to severe neutropenia, netropenia-related events during chemotherapy, dose delays, dose reductions, or no changes in dose or timing]).

• The total sample size was 852.
• All participants were aged 65 years and older.
• The amount of women was 548; the amount of men was 304.
• Key disease characteristics were lung, breast, or ovarian cancer or aggressive NHL.
• In the solid tumor and NHL groups, each of the following age groups were comprised of 33% of the patients: 65–69 years old, 70–74 years old, and 75 years and older.
• 90% were Caucasian and 90% had an ECOG score of 0 or 1.
• The majority of all patients were diagnosed with disease stage III or IV.

• Multi-site  
• Outpatient setting  
• Community cancer centers nationwide

• The phase of care was active treatment
• Application was for elderly care

Phase IV, open-label, randomized, multicenter, community-based trial

• Febrile neutropenia 
• Grade 3 neutropenia
• Chemotherapy regimen
• Solid tumor type
• Pegfilgrastin administered
• Dose delay, dose reduction, hospitalization, and antibiotic use

701 patients with solid tumors. Fifteen were excluded, making the sample size 686 (343 in the pegfilgrastim arm, 343 in the physician discretion arm). Those who completed the study in each arm was 198 in the pegfilgrastim arm  and 175 in the physician discretion arm. Forty-two percent of patients in the discretion arm received pegfilgrastim, most often for grade 3 or 4 neutropenia. There were 151 patients with NHL. Five were excluded, making the sample size 146 (73 in the pegfilgrastim arm, 73 in the physician discretion arm). Thirty-eight patients in each arm completed the study. In the discretion arm, 64% received pegfilgratim.
 

Febrile neutropenia was lower in the all-cycle pegfilgrastim arm compared to the discretion arm, with a 60% reduction in incidence of febrile neutropenia for patients with solid tumors (p = 0.001) and 59% reduction of febrile neutropenia for patients with NHL (p = 0.004). Grade 4 febrile neutropenia was 22% for patients with solid tumors and 75% for patients with NHL in the all-cycle pegfilgrastim arm compared to 58% for patients with solid tumors and 86% for patients with NHL in the discretion arm. Rates of febrile neutropenia in the first cycle for patients with solid tumors were 3%, and 7% for NHL patients in the all-cycle pegfilgrastim arm compared to 7% for solid tumors and 25% for NHL patients in the discretion arm.

Overall, for patients with solid tumors, the all-cycle pegfilgrastim arm had lower rates of grade 3 or 4 neutropenia, dose delays, dose reductions, decreased hospitalizations, and decreased antibiotic use compared to the discretion arm; and similarly for patients with NHL with the exceptions of higher rates of dose delay and dose reductions in the all-cycle pegfilgrastim arm. None of these findings were statistically significant.
 

The most serious adverse event related to pegfilgrastim use was bone pain (12%) in the solid tumor group and in the NHL group (9%) for those receiving all-cycle pegfilgrastim compared to 5% and 4%, respectively, for the discretion arm.

Pegfilgrastin use in older adults undergoing chemotherapy for cancer of the lung, breast, or ovary, or for NHL is safe and effective with use starting in the first cycle for the reduction of febrile neutropenia, grade 3 or 4 neutropenia, febrile neutropenia-related hospitalizations, and antibiotic use. Dose delay and dose reduction were shown to be increased for patients with NHL who received pegfilgrastin at all cycles compared to physician discretion, which may be due to increased use of pegfilgrastin through physician discretion in this population. In addition, due to the use of pegfilgrastin by physician discretion as the comparison group and the unknown information about frequency of dosing in the discretion arm outside of the majority beginning pegfilgrastin treatment following a grade 3 or 4 febrile neutropenic event, coupled with limited statistically significant outcomes, it is difficult to have a definitive conclusion based on these findings. Clinically, however, the outcomes do appear favorable towards use of pegfilgrastin beginning with the first cycle.

• This study was funded by Amgen, the manufacturer of pegfilgrastim, and the study was not blinded. 
• The use of pegfilgrastim for neutropenia and related adverse events in patients with other types of malignancies were not evaluated in this study.
• Fewer patients with NHL were able to be randomized to the discretion arm since physicians often wanted pegfilgrastim started early in these patients due to known neutropenic outcomes.
• In addition, this article was a replication of the article by Balducci et al. (2007), which was the original report of the findings; therefore, this article published two years after the original does not add to the knowledge of efficacy of use of pegfilgrastim.

The administration of pegfilgrastin starting with the first cycle of chemotherapy may reduce neutropenic events and related complications in older adults with cancer. Nurses can be at the forefront of advocating for this therapy, administering it, and monitoring patients for effective outcomes and/or adverse events.

Patients receiving 250 mg/m² IV irinotecan over 90 minutes every two weeks were given 500 mg levofloxacin tablets once at 8 pm and 4 g cholestyramine three times per day (not together with other medications) beginning the day before chemotherapy to day +1. Patients with acute cholinergic syndrome, abdominal cramping, and early diarrhea, were given 0.25-1 mg IV atropine. Patients experiencing delayed diarrhea were offered loperaminde.

• The study reported on 51 patients with metastatic colorectal cancer (CRC) in second-line treatment.
• Mean age was 64 with a range of 41–81.
• Patients had not received prior irinotecan therapy and were refractory or resistant to 5-fluorouracil (5-FU).

This was a phase II trial.

• Patients recorded diarrhea incidence and severity in diaries following each chemotherapy dose.
• Diarrhea severity was measured using World Health Organization (WHO) grading.

• Forty patients (78%) did not develop diarrhea, 11 patients (22%) reported WHO grade 1–2 diarrhea, and only one patient (2%) reported WHO grade 3 diarrhea.
• No patients reported grade 4 diarrhea. 
• Reported incidence of diarrhea without prophylaxis in the literature is up to 40%.

• The study sample was small.
• This was a phase II study.
• Investigators did not conduct pharmacokinetic analyses of the active metabolites SN-38 and SN-38G in plasma.
• No information was provided on the effect of cholestyramine on the efficacy of irinotecan efficacy. If cholestyramine decreases the effects of irinotecan, this could account for a decreased incidence of diarrhea.

Combination cholestyramine and levofloxacin is a promising option for prevention of delayed diarrhea caused by irinotecan and may help to escalate the dose of irinotecan in the future.