Contact information
Type
Scientific
Primary contact
Dr M Gielissen
ORCID ID
Contact details
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 0048
m.gielissen@nkcv.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KUN 2001-2378
Study information
Scientific title
Acronym
Study hypothesis
Quality of life is an integrated part within treatment for cancer. An important but neglected part of quality of life is fatigue, during but also after treatment for cancer. Three recent studies in our institute have shown that 20 - 40% of disease-free cancer patients mention invalidating fatigue as a frequent complaint one to six years after curative treatment for cancer has ended. No relations were found between fatigue long after treatment for cancer and initial disease- and treatment variables. Somatic treatment for these complaints of fatigue is lacking. Cognitive Behaviour Therapy is a promising treatment to reduce fatigue and related functional impairment in patients with Chronic Fatigue Syndrome.
The purpose is to evaluate whether Cognitive Behaviour Therapy is effective in reducing chronic fatigue complaints in disease-free cancer patients, in a randomised-controlled study.
Hypotheses:
1. What is the effect of Cognitive Behaviour Therapy in severely fatigued disease-free cancer patients on fatigue, functional impairment and psychological well being compared to patients waiting for this treatment?
2. Is the effect of Cognitive Behaviour Therapy lasting at six months after treatment and at one-year follow-up?
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Tumour, fatigued cancer survivors
Intervention
All patients who are suitable for this study, based on the inclusion 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 six 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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The major outcome variables in this study are:
1. Fatigue severity
2. Impairment in daily life
3. Psychological well-being
Fatigue severity:
This will be measured using the Checklist Individual Strength. A Self-Observation List (SOL) has been constructed in order to obtain information about severity and frequency of fatigue and other complaints during a two-week period.
Impairment in daily life:
This will be assessed with eight subscales of the Sickness Impact Profile.
Psychological well-being:
This will be measured with the Symptom CheckList. A total score of psychological well-being can be obtained as well.
Secondary outcome measures
Besides the questionnaires used to measure the major outcome variables, additional questionnaires will be used to measure:
1. Depression, anxiety and sleep: the SOL will be used to measure these variables, patients register their quality of sleep every day during a two-week period
2. Social support: this will be measured with the Social Support Questionnaire
3. Physical activity: this will be measured with the actometer, an apparatus developed by our department of Medical Psychology. It records the number of movements in every five minute period. It is worn around the ankle day and night for a consecutive two-weeks
4. Quality of life: 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
5. Self efficacy: this will be measured using a 5-item Self Efficacy Questionnaire
6. Difficulties in getting over the cancer experience: this will be measured with the Dutch version of the Impact of Events Scale
Overall trial start date
01/09/2001
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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 oneyear and maximal ten years ago
3. Disease-free, as defined by the absence of somatic disease activity parameters
4. Aged between 18 and 65
5. No physical comorbidity
6. No current psychological or psychiatric treatment
7. Checklist Individual Strength (CIS) fatigue score of 35 or higher
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
112
Participant exclusion criteria
Does not comply with above inclusion criteria.
Recruitment start date
01/09/2001
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Centre (The Netherlands)
Sponsor details
Expert Centre Chronic Fatigue
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 1111
m.gielissen@nkcv.umcn.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Dutch Cancer Society (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17653075
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21773676
Publication citations
-
Results
Gielissen MF, Verhagen CA, Bleijenberg G, Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up., Br. J. Cancer, 2007, 97, 5, 612-618, doi: 10.1038/sj.bjc.6603899.
-
Results
Gielissen MF, Wiborg JF, Verhagen CA, Knoop H, Bleijenberg G, Examining the role of physical activity in reducing postcancer fatigue., Support Care Cancer, 2012, 20, 7, 1441-1447, doi: 10.1007/s00520-011-1227-4.