Bourmaud, A., Anota, A., Moncharmont, C., Tinquaut, F., Oriol, M., Trillet-Lenoir, V., . . . Chauvin, F. (2017). Cancer-related fatigue management: Evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study. British Journal of Cancer, 116, 849–858.

DOI Link

Study Purpose

To evaluate the effectiveness of a psychoeducational program on cancer-related fatigue

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the study intervention or usual care. Patients in the intervention group (PEPs) received written information explaining cancer-related fatigue and difference approaches for management. Patients in this group were also encouraged to participate in five group educational sessions of two hours each over a six-week period. The PEPs content was designed to incorporate NCI and CPEN guidelines. Content included information about the disease, fatigue, self expression of attitude, coping strategies, and skill development for managing fatigue. Educational teams received a two-day intensive training to standardize program content. Patients in the control group received the written documentation as described. After the study, patients in the control group were offered participation in the program.

Sample Characteristics

  • N = 129   
  • AGE: Mean = 55.9 years
  • MALES: 15.6%  
  • FEMALES: 84.4%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types–over 60% were breast cancer cases. Average of slightly less than one month since diagnosis.
  • OTHER KEY SAMPLE CHARACTERISTICS: Mean baseline fatigue was 5 in both groups.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: France

Study Design

RCT

Measurement Instruments/Methods

  • Numeric rating scale for fatigue intensity
  • FACT-Fatigue
  • Piper Fatigue Scale
  • EORTC-QLQ-C30
  • Hospital Anxiety and Depression Scale

Results

There were no differences between groups in fatigue scores after the intervention, and no differences in the trajectory of fatigue. Fatigue declined overall in all patients. There were no differences between groups in anxiety or depression.

Conclusions

The educational program tested here did not demonstrate an effect on fatigue, anxiety, or depression.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Authors questioned the possibility of study group contamination since all patients were treated at the same clinical centers. No observations to check program fidelity were described. Phase of care is not clear in this report. Question of author bias–authors attribute lack of apparent effect to the need for better fatigue measures.

Nursing Implications

Psychoeducation is an intervention that has shown mixed results for impact on cancer-related fatigue and other symptoms. The specific program tested here did not demonstrate an effect. Fatigue in particular is a complex multifaceted symptom. Various psychoeducational and supportive approaches have also been complex in terms of design, content, timing, dose, etc. The effectiveness of psychoeducational-type interventions may relate to all of these aspects of both content and delivery.