Condition category
Cancer
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
23/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcn.nl/homepage

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

  1. 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.

  2. 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.

Additional files

Editorial Notes