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OncoRev study.


- candidate number1491
- NTR NumberNTR293
- ISRCTNISRCTN 68530111
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleOncoRev study.
- Scientific TitleEffect of a multi-disciplinary rehabilitation program for cancer patients on quality of life: a randomised controlled multicenter trial.
- ACRONYMN/A
- hypothesisMultidisciplinary oncological rehabilitation program has a greater effect on quality of life as compared to physical training and no treatment directly after intervention and in the long term.
- Healt Condition(s) or Problem(s) studiedCancer
- Inclusion criteria1. Age over 18;
2. Diagnosis of cancer (all types included);
3. Last treatment minimally two month;
4. Life expectation of minimally one year;
5. Minimally three times the answer “yes” on the following questions:
a. Physical complaints like aching muscles, problems with coordination, headache, nausea, heart palpitations, shortness of breath;
b. Reduced physical capacity as compared to before the illness, e.g. less able to walk, cycle or walk;
c. Psychological problems like increased level of anxiety, depression, uncertainty, shortage of energy or nervousness;
d. Increased level of fatigue;
e. Sleep disturbances;
f. Problems of coping with reduced physical and psychosocial functioning due to cancer;
6. Knowledge of the Dutch language.
- Exclusion criteria1. Category 3 or 4 of the scheme of Winningham (Winningham 1991);
2. Inability of travelling independently to the rehabilitation centre;
3. Cognitive disorder that might impede the participation in the rehabilitation program (for example: subjects who are unable to be instructed, to think in three dimensions, to fill in questionnaires);
4. Emotional instability that is expected to possibly impede the participation in the rehabilitation program (for example getting divorced at the moment, death of a loved one);
5. Certain restricted risks due to the disease and/or serious co-morbidity (cardiovascular disease, history of long pathology (COPD), diabetes, rheumatoid arthritis;
6. History of and/or actual serious psycho-pathology, psychotic complaints or alcohol abuse;
7. Restricted side-effects of medication (e.g., psycho-pharmaca in high doses);
8. Need for intensive medical treatment or rehabilitation;
9. Participation in any other clinical trial that measures quality of life or physical functions (exception: follow-up evaluation of clinical trials).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2004
- planned closingdate31-dec-2006
- Target number of participants225
- Interventions1. Multidisciplinary oncological rehabilitation program: pysical training combined with psycho-education (12 weeks);
2. Physical training (12 weeks);
3. Waiting list control group (12-24 weeks).
- Primary outcomeQuality of life.
- Secondary outcome1. Fatigue;
2. Self-efficacy (sense of control);
3. Moderating variables focussing at predictors for success (social-demographics variables, disease and treatment related items, psycho-social variables, process variables, social support and use of medical services and medication);
4. Illness perceptions;
5. Self-management/empowerment;
6. Physical condition: maximal: maximal oxygen uptake, maximal heart rate, total work time, HR at steady state, muscular force;
7. Level of activity.
- TimepointsN/A
- Trial web sitehttp://www.oncorev.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. A.M. May-deGroot
- CONTACT for SCIENTIFIC QUERIESDr. W.J.G. Ros
- Sponsor/Initiator University Maastricht (UM), KWF Kankerbestrijding
- Funding
(Source(s) of Monetary or Material Support)
Josephine Nefkens Stichting (Erasmus MC)
- PublicationsN/A
- Brief summaryThe purpose of the present study is to evaluate the effectiveness of a standardised multi-dimensional rehabilitation program for (ex-)patients with cancer on quality of life when compared to physical exercise and a waiting list control group.
After baseline testing, the multidisciplinary and physical rehabilitation group participate in the rehabilitation program for twelve weeks. Halfway and after completion of the rehabilitation program, baseline testing will be repeated.
To determine the long-term effectiveness of the rehabilitation, the questionnaires will be assessed three and nine month after the end of the rehabilitation program.
- Main changes (audit trail)
- RECORD9-sep-2005 - 14-sep-2009


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