Cognitive Behaviour Therapy to reduce severe fatigue and impairment in daily life after curative treatment for cancer.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR107
• Date of registration: 02/08/2005
• Primary sponsor: University Medical Center St. Radboud, Expert Center Chronic Fatigue
• Public title: Cognitive Behaviour Therapy to reduce severe fatigue and impairment in daily life after curative treatment for cancer.
• Scientific title: Cognitive Behaviour Therapy to reduce severe fatigue and impairment in daily life after curative treatment for cancer. - N/A
• Date of first enrolment: 1/9/2001
• Target sample size: 112
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=107
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: G. Bleijenberg

• Name: M. Gielissen

Key inclusion & exclusion criteria

Inclusion criteria: 1. Treated for breast cancer, colorectal cancer, testis cancer, ovarian cancer, uterus cancer, Hodgkin and non-Hodgkin disease of bone and soft tissue tumours;

2. Completion of treatment for cancer minimal 1 year and maximal 10 years ago;

3. Disease-free, as defined by the absence of somatic disease activity parameters;

4. Age between 18 and 65;

5. No physical comorbidity;

6. No current psychological or psychiatric treatment;

7. CIS fatigue score of 35 or higher.

Exclusion criteria: N/A

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Tumour, Fatigued cancer survivors

Intervention(s)

All patients who are suitable for this study, based on the in- and exclusion criteria, will be approached for this study. Patients will be asked to give informed consent and will be randomly allocated to the intervention- or waiting list condition. Next, base-line assessment (T1) will take place. The patients in the intervention condition start immediately with Cognitive Behaviour Therapy. At the end of the therapy, after 6 months, second assessment will take place in both conditions (T2). At this point changes in both conditions will be compared to analyse the effect of treatment. Subsequently, treatment will be offered to the patients in the waiting list condition. Six months later, follow-up assessment for the patients in the intervention condition will take place (T3). At the same time, post-treatment assessment for the patient in the waiting list condition will take place. Finally, again six months later, second follow-up assessment for the patients in the intervention condition will take place and (first) follow-up assessment for the patients in the waiting list condition will take place (T4).

Primary Outcome(s)

Assessment instruments:

The major outcome variables in this study are fatigue severity, impairment in daily life and psychological well-being. Fatigue severity, will be measured using the Checklist Individual Strength (Vercoulen et al., 1994; Vercoulen et al., 1999). SOL has been constructed in order to obtain information about severity and frequency of fatigue and other complaints during a two-week period. The second outcome variable, impairment in daily life, will be assessed with eight subscales of the Sickness Impact Profile (Bergner et al., 1981; Jacobs et al., 1990).




Finally, the third outcome variable, psychological well-being, will be measured with the Symptom CheckList (Arindell et al., 1986). A total score of psychological well-being can be obtained as well.

Secondary Outcome(s)

Besides the questionnaires used to measure the major outcome variables, additional questionnaires will be used to measure depression, anxiety, sleep, social support, physical activity, quality of life, self efficacy and difficulties in getting over the cancer experience. Furthermore, in the Self-Observation List, patients register their quality of sleep every day during a two-week period.Social Support will be measured with the Social Support Questionnaire (van Sonderen, 1993). Physical activity will be measured with the actometer, an apparatus developed by our department of Medical Psychology (Vercoulen et al, 1997). It records the number of movements every five minute period. Worn around the ankle day and night for a consecutive two-weeks. The EORTC consists of five functional scales (physical-, role-, cognitive-, emotional-, and social functioning), nine symptom scales and one scale for global health status.Locus of control will be measured with the Multidimensional Health Locus of Control questionnaire.
Self efficacy will be measured using a 5 ?item Self Efficacy Questionnaire (Vercoulen et al., 1996). Finally, difficulties in getting over the cancer experience will be measured with the Dutch version of the Impact of Events Scale (Horowiz et al., 1979; Brom and Kleber, 1985).

Secondary ID(s)

ISRCTN44562532

KUN 2001-2378

Source(s) of Monetary Support

Dutch Cancer Society