Gielissen, M. F., Verhagen, S., Witjes, F., & Bleijenberg, G. (2006). Effects of cognitive behavior therapy in severely fatigued disease-free cancer patients compared with patients waiting for cognitive behavior therapy: a randomized controlled trial. Journal of Clinical Oncology, 24, 4882–4887.

Intervention treatments were individualized based on patient scores on specific questionnaires that measured the six modules (perpetuating factors) of postcancer fatigue. These included:

1. Insufficient coping with the experience of cancer
2. Fear of disease recurrence
3. Dysfunctional cognitions concerning fatigue
4. Dysregulation of sleep
5. Dysregulation of activity
6. Low social support and negative social interactions.

If a patient had a score on a questionnaire that indicated problems in a specific module, the accessory module became part of the treatment. Therapy only varied in the number of modules, but within each module, the therapy was standardized. The intervention was delivered by three therapists with previous experience with patients with chronic fatigue. Therapy sessions ranged between five and 26 sessions (mean = 12.5 sessions [standard deviation = 4.7 sessions]), with a duration of one hour during a six-month period. Cognitive and behavioral techniques used in therapy addressed the six modules of postcancer fatigue. Patient outcomes were assessed at baseline and six months after enrollment.

• In total, 98 patients with cancer were included.
• The ratio of males:females was almost equal.
• There were multiple diagnoses, the most common being breast cancer (about 30% in both groups).
• Patients in the waiting list condition underwent chemotherapy more often and had less psychological distress compared with patients in the intervention group.
• Participants were excluded if they were receiving current psychological/psychiatric treatment, were younger than 18 years, or were older than 65 years.

• Outpatient clinics of medical oncology, urology, surgery, orthopedic, hematology, and gynecology 
• The rationale for the intervention was based on the model of precipitating and perpetuating factors.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with a

1. Cognitive-behavioral therapy (CBT) intervention (n = 50)
2. Waiting list condition (patients were told that they could start the intervention after the second assessment) (n = 48).

Checklist Individual Strength (CIS)

Patients in the CBT intervention group experienced a statistically significant decline in fatigue severity (difference, 13.3; 95% confidence interval [CI] [8.6, 18.1]), as well as functional impairment (difference, 21.6; 95% CI [12.7, 30.4]) compared with patients in the waiting list condition (p < 0.001). The proportion of patients with significant improvements in fatigue severity and functional impairment was significantly higher than the intervention condition compared with the waiting list condition, indicating clinical significance (p < 0.001).

• The study was limited to patients younger than 65 years; however, 50% of cancer is diagnosed after this age.
• Controlled follow-up was not possible because patients in the waiting list group were offered CBT after the six-month assessment.
• There was no attention placebo control goup; therefore, the possibility cannot be ruled out that attention played a role in the improvements observed in the intervention group.