To evaluate the impact of bright white light exposure on fatigue among cancer survivors

Patients were randomized to receive bright white light or dim red light treatment, using a lightbook device that used light-emitting diode (LED) light. Participants were instructed to self-administer the treatment at home by placing the light box at a 45-degree angle, 18 inches from the face, for 30 minutes every morning for four weeks. Study questionnaires were completed at baseline, after two weeks, at four weeks, and three weeks after study completion.

• N = 36  
• MALES: 19%, FEMALES: 81%
• KEY DISEASE CHARACTERISTICS: Patients with multiple types of cancer. Initial curative treatment had been completed. Patients were an average of 17 months post diagnosis.

• SITE: Single site  
• SETTING TYPE: Home    
• LOCATION: New York

• PHASE OF CARE: Active antitumor treatment

• Randomized, controlled trial

• Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale

Fatigue declined in all over time. At all study time points, the white light group had less fatigue (p = 0.00125). The pattern of change in fatigue also differed between groups. In the red light group, fatigue improved at two weeks but became worse at four weeks and at follow-up. At the end of four weeks, no patients in the bright white light condition were still clinically fatigued.

Daily exposure to bright white light was associated with a significant reduction in fatigue.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• No information is provided about any other interventions received for fatigue during the study.

The findings suggest that exposure to bright white light can be an effective alternative in managing fatigue. This is a relatively low-cost and low-risk intervention that may be helpful. Further research in this area is warranted.

• Databases searched were National Library of Medicine PubMed database, which includes MEDLINE, PreMedline, and other related databases (1979-January, 2000).
• Search keywords were cancer and behavior, intervention, nausea, vomit, depression, anxiety, fatigue, neuro, cognitive, menopause, sex, and post-traumatic stress disorder.
• Studies were included if they were randomized controlled studies, within-subject studies, or case reports.

• The review consisted of 54 studies that met the criteria.
• Three symptom clusters were evaluated. The review included published reports for nausea and vomiting, anxiety/stress, and pain.
• For the nausea and vomiting review, studies must have addressed
  • Cancer-related treatment side effect with behavioral intervention
  • Cancer-treatment intervention effects.

• The following treatments were evaluated: relaxation, hypnosis, cognitive/attentional distraction, desensitization, and rehearsal modeling.
• Four studies for relaxation and hypnosis showed effectiveness of behavioral intervention for control of anticipatory nausea and vomiting (no anticipatory vomiting occurred).
• Results from the individual analyses were confirmed in 12 of 13 randomized-controlled trials that compared behavioral interventions with no treatment/attention control conditions.
• The impact of behavioral intervention on postchemotherapy side effects was less established, with four studies reporting that the behavioral intervention reduced the intensity of the postchemotherapy side effects but did not prevent their occurrence.

To help patients manage fatigue, as well as optimize activity and functioning, through energy conservation and management.

The intervention was comprised of four principle components:

• Detailed assessment of fatigue
• Provision of an educational pack on fatigue management
• Monthly meetings to facilitate the provision of advice and coaching on fatigue management strategies
• Exploration of the meaning of fatigue for patients in their daily lives.

The intervention was provided over the first three treatment cycles.

• In total, 103 (55% male) chemotherapy-naïve patients diagnosed with non-Hodgkin lymphoma or gastrointestinal, non-small cell lung, colorectal, breast, or unknown primary cancer were included.
• Mean age was 56.5 years.
• The disease group was most commonly esophageal (22%), and the disease status was most commonly locoregional disease (45%).
• Patients were excluded if they were being treated for psychiatric illness.

• Multisite
• Inpatient and outpatient
• Clinics at two regional cancer centers in the United Kingdom

Patients were undergoing the active treatment phase of care.

The study was a randomized, two-arm (standard versus experimental treatment), unblinded, controlled trial.

• Visual analog scales (VASs):  subjective quantification of fatigue, subjective distress because of fatigue, and subjective assessment of fatigue effects on chores/work and pastimes/hobbies
• Fatigue diary
• Short Form 36 Health Survey (SF-36)

The experimental group experienced a 20% pre-/posttest decrease in the different dimensions of fatigue, whereas a negligible difference was observed for the control group. Across all measures of fatigue (VASs and the vitality subscale of the SF-36), the experimental group reported less fatigue by the end of the study than the control. The intervention was particularly successful in decreasing distress evoked by fatigue (p < 0.01) and reducing the impact of fatigue on favored pastimes (p < 0.02). Analysis of the mean fatigue score revealed a significant between-group difference in global fatigue (p < 0.03).

• Patients were at liberty to receive fatigue management information and support from outside sources.
• The study was unblinded; therefore, it was possible that patients in the treatment group experienced a placebo effect and that investigator bias may have impacted the results.
• Cost data were not collected; therefore, it was not possible to assess the cost-effectiveness of the intervention.

To report on using a fatigue intervention adapted for telephone use and the findings of an exploratory controlled trial

The Beating Fatigue intervention was delivered over the first three treatment cycles to patients starting chemotherapy. The intervention included fatigue education, fatigue assessment, self-care coaching, and emotional support. Participants were given an information packet, a fatigue diary, and a support nurse consultation with each treatment cycle. The modified version included a telephone consultation and motivation interviewing. The control group received usual care consisting of inquiring about fatigue levels. Phase 1 work was done to establish acceptability. In phase 2, patients were randomly assigned to intervention and control groups.

• N = 44  
• MEAN AGE = 53.3 years
• MALES: 39%, FEMALES: 61%
• KEY DISEASE CHARACTERISTICS: 59% breast, 32% lymphoma, and 9% colorectal
• OTHER KEY SAMPLE CHARACTERISTICS: 68% white British

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Large cancer center in the United Kingdom

• PHASE OF CARE: Active antitumor treatment

Mixed-method exploratory study; phase 1 to explore feasibility and acceptability of telephone-delivered version of intervention; phase 2 to measure treatment effect, patient acceptance, and treatment integrity

• Brief Fatigue Inventory (BFI)
• Fatigue Distress Scale (FDS)
• Hospital Anxiety and Distress Scale (HADS)
• Fatigue Self-Efficacy (FSE) scale 
• Semi-structured interviews
• There was no description of the instruments in the article, including measurement performance (e.g., reliability). Consequently, the full evaluation of the findings are not possible without information regarding instruments not commonly used in research (e.g., FDS, FSE).

Fatigue intensity decreased in the intervention group and increased in the control group (effect size [ES] = 0.18). Distress and anxiety decreased in the intervention group and increased in the control group (ES = 0.62, ES = 0.31, p = 0.05), and self-efficacy increased in the intervention group and decreased in the control group (ES = -0.34, p = 0.05). Depression increased in both groups slightly.

Fatigue improvement was small based on the effect size. Interviews suggested the acceptance of telephone interventions by patients. Distress from fatigue was decreased for participants. The results of this study showed improvement in self-efficacy and anxiety with the intervention.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)

This nurse-delivered intervention may improve patient distress associated with fatigue and reduce fatigue severity. Motivational interviewing might be helpful in managing anxiety. Additional research to develop this evidence is needed.

An energy-dense oral nutritional supplement of eicosapentaenoic acid (EPA-ONS), an anti-inflammatory agent, was shown to reduce weight loss, increase lean body mass, and improve functional capacity and nutritional status in previous research. The EPA intervention instructed patients to consume two tetrapaks (480 mL) of EPA-ONS per day in addition to their regular diet for a total of nine weeks. Tetrapacks contained 16 g of protein, 1.09 g of EPA, and 0.46 g of docosahexaenoic acid (DHA). Chemotherapy commenced at week 4 and was repeated every two weeks. Patient outcomes were assessed at baseline, the end of week 3, and the end of week 9.

• The study was comprised of 23 patients with advanced colorectal cancer (CRC) who had one prior chemotherapy regimen (median age = 61 years).
• The majority of the patients was male (n = 15) and had received previous surgery and chemotherapy (n = 17). 
• Patients were excluded if they had previously received irinotecan, had preexisting intestinal disease, psychiatric disorders, edema, dehydration, or were unable to orally intake medications. Patients who could not have a three-week delay in administering cytotoxic chemotherapy without impacting disease progression were also excluded.

The study was conducted at the Royal Prince Alfred and Concord Hospitals in Sydney, Australia.

Patients were undergoing the active treatment phase of care.

This was an open-label, phase II study.

Disease and treatment assessment (DATA) form

The EPA intervention resulted in a trend toward improvement during the full course of therapy for overall well-being (p = 0.05) and energy (p = 0.03). The quality of life measure for fatigue was maintained at the same mean score throughout the study.

• The study had a small sample size.
• The study lacked a neutral comparison group.

To determine, by means of a meta-analysis and systematic review, the effectiveness of treatment with antidepressants in people with depression in the context of physical illness

• The Cochrane Register of Clinical Trials, MEDLINE,^® EMBASE, PsycINFO, ClinicalTrials.gov, Current Controlled Trials Register, LILACS, CINAHL,^® PSYNEX, AMED, and the pharmaceutical industry trials registers of GlaxoSmithKline and Eli Lilly were consulted.
• The following inclusion criteria were used: any type of antidepressant used; patients older than 18 years, with depression in the context of a physical illness; and depression defined as diagnosis of major depressive disorder, adjustment disorder, or dysthymic disorder, according to DMS-IV or ICD-10 or scores indicative of a diagnosis on validated tools. The main comorbidity was a physical health problem with a biological underpinning, not just symptoms. The control condition was a placebo.
• The study was excluded if patients had psychiatric comorbidity or if the study involved trials in which antidepressants were prescribed to treat symptoms other than those of depression.
   

• A total of 2,230 references were retrieved.
• Risk of bias was evaluated with Cochrane handbook criteria.
   

• 51 studies were included.
• Studies included patients with stroke, AIDS, Parkinson disease, cancer, chronic obstructive pulmonary disease, diabetes, myocardial infarction, renal failure, heart failure, epilepsy, and chronic prostatitis. Age range was 33–82.
• Four of the trials involved patients with cancer, mostly women with breast cancer. In those trials, the age range of the 254 patients was 35–91.
   

Most of the studies involved use of tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs); three studies looked at mirtazapine. In 25 studies providing data on short-term response, odds of response were greater with antidepressants (OR = 2.33, 95% CI, 1.8–3.0, p < 0.00001). Across 20 studies (N = 1,214 patients), at six to eight weeks antidepressants were more effective than placebo in reducing symptoms of depression (SMD = 0.66, 95% CI, –0.94 to –0.38, p < 0.00001). Analysis of medium-term response at 9–18 weeks showed odds of response were greater with antidepressant drugs than placebo (OR = 2.08, 95% CI, 1.33–3.24, p = 0.00001). Long-term response ( > 18 weeks) was better with antidepressants than placebo (OR = 2.13, 95% CI, 1.31–3.47, p = 0.002). Heterogeneity had a low impact on the meta-analysis reported. In the short term, fewer patients receiving placebo dropped out of the study. Most frequent adverse events were dizziness, dry mouth, headache, nausea, constipation, insomnia, sexual dysfunction, sedation, hypotension, and appetite change. No trials studied patients with advanced cancer,

Antidepressants were superior to placebo for treatment of depression in people with a physical illness.

The large number of studies were of relatively low quality, which may have inflated the effect sizes calculated. Depression was presumed to be similar across physical diseases. No subgroup analysis was conducted for different diseases.

Findings showed that treatment with antidepressants is superior to use of placebo in patients with physical illnesses who have moderate or major depressive disorders in the context of the physical illness. Antidepressants may benefit patients with cancer who have moderate to major depression. Applicability of antidepressants for patients with advanced cancer is unknown. Nurses should be aware of the side effects of antidepressants and how they may contribute to various disease or treatment symptoms.

The intervention consisted of three parts:

1. A computer-based nursing intervention that provided assistance with symptom management and information about disease and treatment
2. Emotional counseling and support
3. Coordination of services.

The research team created this computer-based intervention for 38 symptoms that may occur during chemotherapy. The computer-based nursing intervention was a menu-driven computer program that guided clinical assessment, problem identification, selection of interventions, and measurement of outcomes. It was designed based on current literature, oncology nursing practice standards, and practice guidelines for cancer symptom management. Each symptom or problem had a problem-specific list of appropriate interventions. Emotional support and counseling consisted of the nurse using active listening and teaching of active communication techniques to patients and their caregivers to enhance communication between patients, caregivers, family, and healthcare providers. The intervention occurred over 18 weeks and consisted of nine visits (five in person and four via telephone). Visits took approximately one hour. Telephone encounters took about 20 minutes.

Dyads were recruited within 56 days of chemotherapy initiation. After completion of baseline telephone interviews, dyads were randomly assigned to groups. Data were collected via telephone interviews at three time points during the six-month study: time 1 = entry into study, time 2 = nine weeks or halfway through the intervention, and time 3 = 24 weeks or one month after the intervention.

• The study reported on a sample of 109 dyads (patient and identified caregiver).
• Patients were newly diagnosed with breast, colorectal, or lung cancer and were undergoing chemotherapy.
• The intervention group had 55 dyads, and the conventional care group had 54 dyads.

A randomized controlled trial (RCT) design was used.

• Medical Outcomes Study 36–Short Form (SF-36)
• Center for Epidemiologic Studies–Depression-20 scale (CES-D-20)
• State-Trait Anxiety Inventory (STAI)–state anxiety
• Statistical analyses: t tests and repeated ANOVA for SF-36, CES-D-20, and STAI
• Reliability analyses were completed using Cronbach’s alpha for scales of each time (baseline, time 2, and time 3).

Role emotional, mental health, and mental component scores were significant for the group-by-time intervention (p = 0.1). The intervention did not have a significant effect on anxiety when examining the date from the three time points. However, a trend toward group-by-time interaction (p = 0.09) occurred between baseline and time 2, favoring the intervention group. Pair-wise comparisons of the means showed that the intervention group improved (lower anxiety scores) from baseline to time 2 (p = 0.09), whereas the standard care group remained unchanged. Time 3 data were collected approximately four weeks after completion (24 weeks following enrollment), and any effect the intervention had may have been lost by time 3. Additional analyses were performed on baseline and time 2 data only.

The study was a strong RCT with a good sample size.

• New computer-based nursing intervention was created.
• The intervention was administered by three advanced practice nurses.
• The intervention was time-intensive.

To evaluate the most efficient topical hydrating treatment in the prevention of cutaneous radio-induced effects in breast cancer

Topical treatments used in comparison were Pure Vitamin E; Omega 3, 6, and 9; Betaglucan; sodium hyaluronate; Ixoderm; and Xderit. Patients started using the skin emollients at the start of therapy until three months after completion of therapy. They were not allowed to use any other ointments during the course of therapy.  Any patient who developed a grade 2 or higher skin toxicity stopped the topical treatment and were treated with cortisone creams.

• The study sample (N = 100) was comprised of feamle patients with breast cancer.
• In the study sample, 53% had prior chemotherapy and 75% were receiving hormonal agents during and after radiation therapy.

The study took place in across multiple outpatient sites in Italy.

Patients were undergoing active antitumor treatment.

The study used an observational design.

The Radiation Therapy Oncology Group and European Organisation for the Research and Treatment of Cancer skin toxicity grading scale was used.

There were no grade 2 or 3 toxicities. No differences in toxicities associated with individual agents used could be determined because of the number of different agents used and the small number of patients observed.

 No conclusions can be drawn from this report regarding any comparisons of topical agents used.

• The sample size was small, with less than 100 patients.
• The groups had important differences.
• The study had a risk of bias due to no control group, no blinding, and no random assignment.
• Measurement methods were not described.
• Variation in patients regarding the combination of chemotherapy and radiation therapy could influence results.
• No description of total radiation therapy dosages. 
• No patient demographics provided.

 The study does not add much to evidence regarding prevention or management of radiodermatitis.

115 patients with symptomatic chemotherapy-induced peripheral neuropathy (CIPN) were randomized to the order of receiving oral gabapentin or placebo for six weeks separated by a two week “washout” period and crossing over to the other treatment group for six weeks. Gabapentin doses (300 mg capsules) and identical placebo doses were escalated over three weeks to a target dose of 2,700 mg of gabapentin per day, or nine placebo capsules per day.

• N = 115
• n = 57 assigned to receive gabapentin first
• n = 58 assigned to  receive placebo first.
• 115 adult patients with longer than one month duration of symptomatic CIPN who reported scores of 4 or higher for average pain on a 0–10 numeric rating scale (NRS), or a score of 1 or higher on the Eastern Cooperative Oncology Group (ECOG) neurosensory (ENS) toxicity item (possible ENS scores are 0–3, with 1 defined as mild paresthesias [loss of deep tendon reflexes]).
• Fifty percent of the participants were receiving chemotherapy at study entry. 
• Exclusion criteria included preexisting neuropathy and use of antidepressants, opioids, adjuvant analgesics, topical analgesics, and/or amifostine at baseline.
• Stratified random assignment was used with stratification on type of chemotherapy and whether patients were receiving chemotherapy or had completed chemotherapy.

The study was a phase III randomized, double-blind, placebo-controlled crossover trial.

Primary outcomes were pain and neuropathy symptoms measured by NRS (0 = no pain and 10 = worst pain possible) and the ENS (0 = none and 3 = severe objective sensory loss or paresthesias that interfere with function). These self-report data were collected weekly in reference to a single day

Secondary measures included:

• Tthe World Health Organization (WHO) classification scale for neuropathy-related symptoms
• The Short Form-McGill Pain Questionnaire
• The Brief Pain Inventory-Short Form
• The Subjective Global Impression of Change
• The Symptom Distress Scale
• The Profile of Mood States (POMS) Short Form
• And a quality of life uniscale.

These data were collected at baseline, 6, 8, and 14 weeks.

No differences were noted between groups at baseline, 6, or 14 weeks in the average pain NRS and the ENS. However, worst pain was lower in the placebo followed by gabapentin group at 14 weeks (p = 0.05). The only significant difference between the groups was in the McGill Pain Rating Index, which showed lower pain in the gabapentin group at the end of the first six week treatment period (p = 0.03).

Gabapentin did not improve symptoms of CIPN.

• A mixed sample of varying cancers, treatments, and time since chemotherapy could confound results.
• Patients with greater severity of pain may benefit from gabapentin. However, these patients were excluded from the study as they were taking opioids prior to the start of the study.
• Forty percent of the participants between the two groups were lost to follow-up (115 started treatment and 68 completed treatment).
• Because the eight-week results were not presented, it is not possible to determine if the groups were equivalent at the beginning of the second treatment period. Data on the POMS total and subscale scores were not included. 
• The means presented  at baseline did not include scores from participants who dropped out of the study.
• The authors noted that using separate tests at each time point without adjusting the alpha level to compensate may have contributed to the inconsistent findings among the pain instruments. 
• The ENS instrument considers that all parasthesias involve pain through subjective report and this may then increase or decrease depending on the amount of error in self report and can prove to be problematic when interpreting the results.