To determine the efficacy of three different mouthwashes in the treatment of chemotherapy-related mucositis

All patients received the PRO-SELF Mouth Aware (PSMA) educational program from a nurse who was blinded to the intervention treatment. The program included didactic information, the development of self-care strategies, and nurse support in the treatment setting. Good oral hygiene was an emphasis of the program, and patients were provided with specific oral hygiene practices to follow during chemotherapy. Nurses contacted the patients via telephone every other day. Patients were randomly assigned to receive one of three possible intervention treatments that were given to the patient in 1-pint opaque plastic bottles. The interventions were either salt and soda, chlorhexidine, or magic mouthwash. Nurses received training in the PSMA program every six months. Patients used the mouthwash four times per day until symptoms resolved or for 12 days. Patients swished 20 mL of their intervention mouthwash for 20 seconds and spit. Mouthwash bottles were collected when symptoms resolved or on day 12, whichever came first, and remaining medication was measured to gauge patient compliance. Oral assessments began upon enrollment, and the first assessment was conducted by a physician or nurse. Patient-directed oral assessments continued thereafter, four times per day, or until mucositis resolved or for 12 days, whichever came first.

• N = 142  
• MEAN AGE = 59.25 years
• MALES: 36%, FEMALES: 64%
• KEY DISEASE CHARACTERISTICS: Multiple types of cancer 

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded clinical trial

• Oral Assessment Guide (OAG)

There were no differences between any of the groups in the time to cessation of mucositis symptoms (F2,141 = .52, p = .59). The mean number of days to cessation of symptoms was 6.59 days in the chlorhexidine group, 7 days in the salt and soda group, and 7.17 days in the magic mouthwash group.

Although clinicians regularly use chlorhexidine mouthwash, this study demonstrates that there is no difference between treatments of salt and soda rinses and magic mouthwash as part of a treatment protocol for chemotherapy-induced oral mucositis. Participants in the magic mouthwash group reported the highest mean number of days to cessation of symptoms, indicating this is the least effective treatment of the three.

• Unintended interventions or applicable interventions not described that would influence results 
• Other limitations/explanation: It is unclear what additional interventions for mucositis were used during the intervention period.

Educating patients about proper oral hygiene while receiving chemotherapy is important. Nurses should be aware, however, that there is no difference between chlorhexidine mouthwash, salt and soda rinses, and magic mouthwash, the three mouthwashes traditionally used in the clinical setting. As the least effective of the mouthwashes in terms of mean days to cessation of symptoms, magic mouthwash does not appear to be an effective intervention in the treatment of chemotherapy-induced oral mucositis.

The primary aim was to evaluate the effectiveness of a home-based exercise training intervention called the Pro-self:  Fatigue Control Program on the management of cancer-related fatigue (CRF). The secondary aim was to study the effects of the intervention on sleep disturbance, depression, and pain.

Patients were randomized to one of three groups. Two groups received a home-based prescription for exercise called the Pro-self:  Fatigue Control Program (during and after cancer treatment). One of these groups had follow-up. The third group received usual care. All patients completed four valid and reliable tools at baseline, the week before the second chemotherapy treatment, at the end of cancer treatment, and at the end of the study (about one year after the start of the study). The tools measured fatigue, sleep disturbance, depression, and pain and were analyzed to compare how fatigue and other study variables had changed over time and by groups. It was a randomized, single-blind, three-arm, controlled trial design.

• The sample was comprised of 119 women.
• Patients had to be 18 years or older to enroll.
• Mean age was 50.5 years.
• Patients had colon (n = 1), ovarian (n = 6), and breast (n = 112) cancer.
• Patients had a mean education of 16.1 years. 
• Mean Karnofsky Performance Status (KPS) was 87.63. 
• A mean of 94 patients were employed.

• Setting Type1:  Multisite
• Setting Type2:  Outpatient setting
• San Francisco Bay Area

The study was a randomized, controlled trial (RCT).

• Piper Fatigue Scale (PFS) (α range .96–.97)
• General Sleep Disturbance Scale (GSDS) (α range .83–.86)
• Center for Epidemiologic Studies Depression Inventory (CESD) (α range .80–.89)
• Worst of Pain Intensity Scale
• KPS
• Intervention Framework:  Pro-self:  Fatigue Control Program based on self-care and adult learning theory
• Data Analysis used SPSS version 15, two-tailed tests and multilevel regression analysis. 

Change in fatigue did not change over time. No significant change in fatigue occurred among groups.

The home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined.

When the study was conducted, the benefits of exercise were being reported in the literature and patients could not be asked to stop their regular exercise. The PFS was administered only three times a year, which might not be frequent enough to capture the true effect of exercise on CRF. The self-report of exercise behaviors was obtained with no objective measures.

CRF is a common problem. Some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.

To examine the effectiveness and feasibility of the Family involvement, Optimistic attitude, Coping effectiveness, Uncertainty reduction and Symptom management (FOCUS) program on the quality of life (QOL), benefits of illness and caregiving, communication, and support of cancer survivors and their caregivers in a cancer support community (CSC) site using a small group format

Researchers modified the FOCUS program (a nurse-delivered, home-based intervention for patient/caregiver dyads) for use and administration by social workers at a CSC site to cancer survivors and their caregivers. The program was administered in six sessions over six weeks to three to four dyads in a small-group format.

• N = 34 dyads
• AVERAGE CAREGIVER AGE = 53.4 years (range = 31–70 years)
• MALES: 65%, FEMALES: 35%
• KEY DISEASE CHARACTERISTICS: Cancer survivors were defined as any person who received a diagnosis of cancer from the time of initial diagnosis until his or her death. Any type or stage of cancer was admissible in the sample as long as other eligibility criteria were met.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of caregivers were males, spouses of survivors, married, Caucasian, highly educated, and in good to excellent health.

• SITE: Single site    
• SETTING TYPE: Other    
• LOCATION: CSC in Ann Arbor, MI

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

Pre- and postintervention study with no control group

• Functional Assessment of Cancer Therapy–General (FACT-G) to assess quality of life (primary outcome)
• Benefits of Illness Scale (BIS) to assess perceived benefits of illness or caregiving
• Mutuality and Interpersonal Sensitivity Scale (MISS) to assess dyadic communication
• Cancer Self-Efficacy Scale (CASE) to assess self-efficacy
• All measures appeared to have sufficient reliability and validity.
• The feasibility of the modified FOCUS program was assessed by rates of enrollment, retention, intervention fidelity, and participants’ satisfaction. 

The intervention effect was assessed by dyadic scores (survivors and caregivers were treated as a unit). Dyadic QOL (physical, emotional, and functional) was significantly improved from preintervention to postintervention, but there was no improvement in social QOL. Dyadic perception of illness and self-efficacy also were significantly improved, but dyadic communication and support were not. The dyadic main effect size ranged from small to moderate for different outcomes. Effect sizes were larger for survivors than for caregivers. For feasibility, the enrollment rate was 60%, retention was 92%, and the intervention fidelity was 94%. Caregivers and survivors were highly satisfied with the intervention.

The modified FOCUS program was feasible and effective when administered to small groups of survivor/caregiver dyads. However, the assessment of improvement in outcomes considering the dyad a unit may lead to confusion in interpreting the outcomes of specific participants (survivors versus caregivers). 

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results 
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: This was a well done study despite the identified limitations.

Tailored interventions to assist caregivers are effective. Collaborations with community settings that allow for the administration of evidence-based programs assisting caregivers may make such interventions more feasible and available to larger numbers of patients and caregivers. Careful attention to intervention fidelity is essential when programs are translated on a larger scale.

To determine if dietary counseling, oral nutrition, and megestrol acetate affect nutritional status and survival in patients with advanced cancer

Consecutive patients were given nutritional counseling, 400 mg per day megestrol, oral supplements of 600 kcal per day, and a product containing eicosapentaenoic acid with an additional 600 kcal. Prospective patients were then compared to historical controls when nutritional supplements were not available in the country. Patients were followed for up to 24 weeks.

• N = 628
• MEDIAN AGE = 67.5 years (SD = 2.7 years)
• MALES: 56.3%, FEMALES: 43.7%
• KEY DISEASE CHARACTERISTICS: Colorectal cancer; about 2/3 had metastatic disease

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Croatia

• PHASE OF CARE: Multiple phases of care

Prospective and observational with a historical control comparison

• Body weight
• Eastern Comparative Oncology Group (ECOG) Performance Status
• Appetite loss scale

This study reports a higher prevalence of diarrhea and water retention in patients receiving nutritional intervention. It reports a lower prevalence of loss of appetite at 12 weeks in those given the intervention compared to historical controls (p = .0046) and improvement of appetite by 12 weeks in the intervention group (p = .0046). Survival curve analysis showed improved survival among those who received the intervention (p = .022)

Oral dietary supplements and nutritional counseling may benefit patients with advanced colorectal cancer.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Measurement/methods not well described
• Other limitations/explanation: Method of measurement for appetite not described; megestrol acetate has been shown to improve appetite, so it is not clear what effect the other components of the intervention had on appetite.

Dietary counseling and provision of oral nutritional supplements may be of benefit to patients.

To investigate practices for antifungal prophylaxis and incidence of invasive fungal disease (IFD)

A retrospective chart review was conducted to collect data on patients from beginning of induction to completion of consolidation regarding the use of antifungal prophylaxis and IFD outcomes. Cost analysis was included.

• N = 98   
• MEDIAN AGE = 43 years
• MALES: 65%, FEMALES: 35%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had acute lymphoblastic leukemia

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Australia

PHASE OF CARE: Active antitumor treatment

Retrospective

European Organization for Research and Treatment of Cancer (EORTC) criteria for proven, possible, or probable IFD

Ninety-eight percent had neutropenia ranging from 18–45 days in duration. Prophylactic antifungal agents were given to 85% of patients. The only significant difference between those who developed IFD and those who did not was the use of antifungal prophylaxis. Those receiving prophylaxis had a lower incidence of proven or probable IFD  (2.6%) than others (21.4%) (p = 0.024). IFD incidence was highest in patients receiving BFM95 treatment (hyper-CVAD: hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone). Cost of care for those with IFD was significantly higher from hospitalization, diagnostic testing, and antifungal treatment costs (p < 0.001).

The use of antifungal prophylaxis was associated with a lower incidence of IFD and associated healthcare costs.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Antifungal prophylaxis in at-risk patients was shown to be effective in reducing the incidence of IFD and associated healthcare costs.

To examine effects of a rehabilitation program

Patients were randomly assigned to an early exercise group or a delayed exercise group. Participants attended rehabilitation sessions five times per week for four weeks. Sessions involved the use of upper and lower extremity stretching, aerobic, and strengthening exercises. During weeks 1–4, the early exercise group participated, and during weeks 4–8, the delayed group participated. Patients were evaluated at baseline and at two, four, six, and eight weeks.

• N = 62  
• MEAN AGE = 46.1 years (SD = 8.5 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; 53% had a lumpectomy; and all completed initial cancer treatment

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: South Korea

• PHASE OF CARE: Active antitumor treatment

Randomized, parallel group trial with repeated measures

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
• Cycle test for cardiorespiratory function
• Fatigue Severity Scale (FSS)
• Muscle strength measurements

Patients in both groups showed significant improvements in all measures except body image (p < 0.001). The greatest improvements were shown during the period of time that individuals were participating in the exercise sessions in both groups. There was no significant difference between groups.

The exercise combinations used here were effective in reducing fatigue and improving quality of life among participants

• Small sample (< 100)
• Risk of bias (no blinding)
• Other limitations/explanation: Out of the 212 people who initially consented, only 62 actually participated in the study. This suggests that the program may not be acceptable to the majority of patients. There is a possible testing effect with repeated measures over a short period of time. No information is provided regarding adherence to exercise sessions.

The findings of this study add to the already extensive body of evidence that various forms of exercise are beneficial to reduce fatigue in patients with cancer. This study showed effects specifically during the time in which participants were exercising, suggesting the need for ongoing involvement in activity to maintain effectiveness

To examine the effects of adding resistance exercise to complete decongestive therapy (CDT) on arm volume, function, strength, and quality of life

Patients were randomized to intervention and control groups. The control group received CDT alone for one to two weeks, and those with severe lymphedema also had bandaging. The intervention received the same CDT, as well as exercise using resistance bands. Resistance exercises included isolated shoulder movements five times per week for eight weeks with three sets of 10 repetitions of exercises. Study assessments were conducted at baseline and after eight weeks. Arm volume measurement was taken at two weeks.

• N = 44   
• MEAN AGE = 49.7 years
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Breast cancer. All had confirmed secondary lymphedema.
• OTHER KEY SAMPLE CHARACTERISTICS: Body mass index greater than 25 was seen in 9% of intervention and 19% of control patients.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: South Korea

PHASE OF CARE: Late effects and survivorship

Randomized, two group trial

• Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire for physical function and arm disability
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
• Arm circumference measurements
• Dynamometer muscle strength measurements

Both groups showed improvement in quality of life scores and arm volumes with no significant differences between groups. Arm disability scores were significantly lower in the intervention group post-treatment (p = 0.001).

The addition of resistance exercise to CDT improved arm function, reduced disability, and did not have any adverse effects on arm lymphedema volume.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• More women in the control group had high body mass index associated with increased risk for lymphedema.

The findings support the addition of moderate intensity resistance exercise to CDT for the management of lymphedema. Resistance exercise was associated with improved function, less arm disability, and no adverse effects on lymphedema volume. Nurses can recommend that patients use moderate exercise of this sort. Resistance exercise can be done with resistance bands—an inexpensive and practical way to achieve this intervention.

The intervention was delivered by a master’s prepared nurse and consisted of four weekly classes and two weeks of treatment conducted through individual weekly telephone sessions. Each class followed a standard format using a treatment manual. The cognitive-behavioral therapy (CBT) intervention consisted of stimulus control instructions, sleep restriction therapy, sleep education, and hygiene content, including cognitive strategies. The aim of the stimulus control interventions was to shape cognitions to reassociate the bed and bedroom with rapidly falling asleep or falling back to sleep. The aims of stimulus control were to acquire a consistent sleep pattern, strengthen the bed and bedroom as cues for sleep, and weaken them as cues for activities that interfere with sleep. Sleep restriction therapy was based on the observation that people with insomnia spend too much time in bed attempting to sleep. The treatment focused on developing a sleep-wake schedule that consolidates sleep and limits it to a specific time by restricting the amount of time spent in bed. Sleep education and hygiene consisted of giving basic information about sleep processes and functions, developmental sleep changes, circadian rhythms, individual sleep needs, sleep deprivation, and supportive information. Dysfunctional cognitions that may contribute to sleep difficulty were also challenged.

• Seventy-two women with breast cancer were included.
• Mean age was 58 years. 
• Patients were at least three months postcompletion of primary treatment and without current evidence of disease.
• Patients were predominantly Caucasian (96%) and married (68%).
• Of the patients, 68% were either retired or employed full-time.
• Most patients had stage I (50%) or II (29%) disease at diagnosis.
• The exclusion criteria included cognitive impairment as determined by Mini-Mental State Examination and/or suspicion of sleep apnea, restless leg syndrome, or periodic limb movement disorder.

• Large university in the southwestern United States
• Women were recruited primarily from newspaper advertising, doctor referral, and breast cancer support groups.

This was a randomized, controlled trial with assignment to either CBT for insomnia or a control group that received education about sleep and sleep hygiene.

Profile of Mood States Fatigue/Inertia Subscale (POMS-F/I)

Women in the intervention group demonstrated significantly lower fatigue compared to those in the control group. The authors concluded that because mediation analyses indicated that the intervention had no direct effect on any of the psychosocial outcomes, that the intervention had an indirect effect on the outcome of fatigue due in part to improvements in sleep quality (both groups demonstrated improvements in mean scores for insomnia severity across the course of the study, and in a study reported elsewhere, they also demonstrated significant improvements in other sleep outcome indicators and favorable changes in actigraphy).

• Outcomes were evaluated immediately following the intervention; therefore, the long-term sustainability of the intervention effects is not known.
• It was difficult to isolate the components of the intervention that produced improvement because both the intervention and the control group received psychological and peer group and individual support, as well as the sleep education and hygiene component of the CBT intervention.

A modest amount of continuing education, as well as access to some instructional materials for patients, are needed to prepare health care professionals to deliver CBT interventions for insomnia.

To evaluate the short-term benefits of low-level laser therapy (LLLT) when added to the conventional management of breast cancer-related lymphedema (BCRL)

All patients had experienced at least one conventional treatment modality, such as complex physical therapy, manual lymphatic drainage, or pneumatic pump therapy. LLLT was added to patients' ongoing therapeutic regimen. All patients completed two cycles of LLLT. Assessment took place before and after the first and second cycle of LLLT sequentially.

• The study sample (N = 17) was comprised of female patients with BCRL.
• Mean age was 51.8 years, with a range of 44–64 years. 

The study took place in an outpatient setting at the University of Pittsburgh Medical Center. 

The study used a quasi-experimental design.

• Arm lymphedema was identified by measuring limb circumference.
• Pain was measured using a typical pain diagram with a 0–10 subjective pain score.
• Shoulder range of motion was measured using goniometric values.
• The Patient and Observation Scar Assessment Scale (POSAS) was used in the study.

The difference between sums of the circumferences of the affected and unaffected arms decreased 54% and 73% after the first and second cycles of LLLT, respectively. Eighty-two percent of patients 14 out of 17 experienced decreased pain with motion by an average of 40% and 62.7% after the first and second cycle of LLLT, respectively. Scar mobility increased in 13 (76.4%) and shoulder range of motion improved in 14 (82.3%) patients after LLLT. One patient developed cellulitis during LLLT.

Patients with BCRL received additional benefits from LLLT when used in conjunction with standard lymphedema treatment, including reduction in limb circumference, pain, increase in range of motion and scar mobility.

• The study sample was small, with less than 30 patients.
• Results are potentially bias because there was no control group. 

Further studies with appropriate sample size and control groups are necessary to assess the long-term effects of LLLT in combination with conventional treatments as well as the effect of the repetitive application.

To compare the safety and efficacy of polyethylene glycol (PEG) versus placebo over a six-month treatment period in patients with chronic constipation.

PEG 3350 (Miralax^®) laxative 17 g or placebo was administered daily for six months. Patients were randomly assigned in a 2:1 ratio to PEG or placebo. This was a subjects mixed study. Medication was administered in 8 oz of juice or another beverage. Bisacodyl 10 mg (5 mg tablets) was used as rescue medication for severe discomfort related to constipation. Fiber was prohibited. Other nonconstipating medications were allowed.

• The study reported on a sample of 204 patients in the treatment group and 100 patients in the placebo group.
• Mean patient age was 53 years (range 20 to 92).
• The older adult subgroup comprised patients aged 65 years or older (n = 75).
• The sample comprised 258 women (85%).
• The sample was 84% Caucasian, 13% African American, and 3% Hispanic or Latino.
• Average duration of constipation was 23 years.
• Patients were included in the study if they had a three-month history of fewer than three bowel movements (BMs) per week when not taking laxatives and one or more remaining Rome symptom criteria. Patients also had an average of three or fewer satisfactory BMs per week during the 14-day observational period after eligibility criteria were met.
• Patients were excluded if they had loose stools, sufficient criteria for irritable bowel syndrome, and currently were being or previously had been treated with PEG.

50 centers in the United States

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

• During the 14-day observational period and qualification period, baseline constipation status was confirmed.
• During the treatment period, data were collected through an interactive voice response system daily to record BM experiences. Patients answered daily and weekly questions (e.g., number of BMs, straining, lumpy or hard stools, evacuation complete, satisfaction, cramping) on a Likert-type scale from 0 (none) to 4 (extreme).
• Amount of gas was rated on a Likert-type scale from 0 (no gas) to 4 (extreme gas).

• Of 609 patients screened, 300 did not meet criteria or failed the 14-day observational period. Of the remaining patients, 306 enrolled and were randomized, and 2 were excluded. A total of 175 patients completed the study.
• Primary analysis was based on intention to treat (ITT).
• Efficacy of the primary variable, treatment success, was defined as relief of modified Rome criteria for constipation for 50% or more of a patient's treatment weeks. The PEG group achieved significant benefit (p < 0.001) versus placebo in 11 of 12 primary and secondary measures.
• The total sample had a 41% difference in treatment response (52% in the PEG group versus 11% in the placebo group, p < 0.001).
• The older adult group had a 46% difference favoring PEG.
• The treatment group had more total BMs per week.
• Total compliance with study medication was higher than 86%.
• Patient withdrawal was equivalent for each reason category, except lack of efficacy; twice as many patients in the placebo group withdrew secondary to lack of efficacy.

PEG is safe and effective in management of constipation in adults and older adults for up to six months.

The study focused on chronic constipation and lacked focus on cancer or opioid-induced constipation.