Foster, C., Grimmett, C., May, C.M., Ewings, S., Myall, M., Hulme, C., . . . Richardson, A. (2016). A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: A multi-centre proof of concept randomised controlled trial. Supportive Care in Cancer, 24, 2445–2453. 

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.