Ream, E., Richardson, A., & Alexander-Dann, C. (2006). Supportive intervention for fatigue in patients undergoing chemotherapy: a randomized controlled trial. Journal of Pain and Symptom Management, 31, 148–161.

DOI Link

Study Purpose

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

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • 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.

Setting

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

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

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

Measurement Instruments/Methods

  • 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)

Results

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).

Limitations

  • 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.