Armes, J., Chalder, T., Addington-Hall, J., Richardson, A., & Hotopf, M. A randomized controlled trial to evaluate the effectiveness of a brief, behaviorally oriented intervention for cancer-related fatigue. Cancer, 110, 1385–1395.

DOI Link

Study Purpose

To test the effectiveness of a brief intervention using a cognitive and behaviorally oriented approach on symptoms of fatigue.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the intervention or usual care control group. The intervention included three individual face-to-face, sixty-minute sessions that coincided with chemotherapy treatment schedules. These were aimed at clarifying meanings, setting goals, educating patients about cancer-related fatigue, developing and discussing coping strategies, and cognitive restructuring. Sessions were audiotaped to ensure treatment fidelity. Study assessments were performed at baseline (cycle three of chemotherapy), the end of treatment, four weeks after the end of treatment, and nine months after study entry.

Sample Characteristics

  • In total, 50 patients (40% male, 60% female) were included.  
  • Mean age was 59.1 years (standard deviation = 11.5 years).
  • Colorectal cancers were the most common. Multiple other tumor types were included
  • Of the patients, 80% had stage III or IV disease, and 76% had at least one other comorbid condition.

Setting

  • Single site 
  • Outpatient 
  • United Kingdom

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • 100-mm visual analog scale (VAS) for global fatigue
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Fatigue outcome measure designed for the study
  • Multidimensional Fatigue Inventory (MFI)
  • Hospital Anxiety and Depression Scale (HADS)

Results

VAS fatigue scores were significantly lower in the experimental group at Time 2, end of treatment (p = 0.03), but not at any other time point. EORTC physical functioning scores were higher in the experimental group at the end of treatment (p = 0.001) and at four weeks after treatment ended (p = 0.02). There was an overall trend over time favoring the experimental group; however, the trend was not significant and was smaller when data were controlled for medical conditions and HADS scores. No data for the nine-month time after treatment were provided.

Conclusions

Findings suggest that a cognitive-behavioral approach intervention can be beneficial in reducing fatigue during the short term after cancer treatment.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • Subject withdrawals were 10% or greater. 

Nursing Implications

Findings suggest that cognitive-behavioral approach interventions to restructure thinking, set goals and coping strategies, and improve self-efficacy may be helpful in reducing fatigue immediately after chemotherapy treatment. This evidence is not strong, given the study limitations here, but the findings are potentially promising.