OncoRev study: effect of a multi-disciplinary rehabilitation program for cancer patients on quality of life - a randomised controlled multicentre trial

ISRCTN ISRCTN68530111
DOI https://doi.org/10.1186/ISRCTN68530111
Secondary identifying numbers NTR293
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
17/09/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr A M May-de Groot
Scientific

University Medical Center Utrecht
Julius Centrum
STR. 6.131
P.O. Box 85060
Utrecht
3508 AB
Netherlands

Phone +31 (0)30 2539308
Email a.m.may@umcutrecht.nl

Study information

Study designMulticentre, randomised, single blind, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesMultidisciplinary 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.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedCancer
Intervention1. Multidisciplinary oncological rehabilitation program: physical training combined with psycho-education (12 weeks)
2. Physical training (12 weeks)
3. Waiting list control group (12 - 24 weeks)
Intervention typeOther
Primary outcome measureQuality of life
Secondary outcome measures1. Fatigue
2. Self-efficacy (sense of control)
3. Moderating variables focusing 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, heart rate (HR) at steady state, muscular force
7. Level of activity
Overall study start date15/03/2004
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants225
Key inclusion criteria1. Aged over 18 years
2. Diagnosis of cancer (all types included)
3. Last treatment minimally two month
4. Life expectation of minimally one year
5. Minimum of three answer “yes” to the following questions:
5.1. Physical complaints like aching muscles, problems with coordination, headache, nausea, heart palpitations, shortness of breath
5.2. Reduced physical capacity as compared to before the illness, e.g. less able to walk, cycle or walk
5.3. Psychological problems like increased level of anxiety, depression, uncertainty, shortage of energy or nervousness
5.4. Increased level of fatigue
5.5. Sleep disturbances
5.6. Problems of coping with reduced physical and psychosocial functioning due to cancer
6. Knowledge of the Dutch language
Key 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 lung pathology [chronic obstructive pulmonary disease], 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)
Date of first enrolment15/03/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Utrecht
Utrecht
3508 AB
Netherlands

Sponsor information

Dutch Cancer Society and Maastricht University (The Netherlands)
Charity

P.O. Box 75508
Amsterdam
1070 AM
Netherlands

ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Charity

Josephine Nefkens Foundation (Josephine Nefkens Stichting) (The Netherlands) - Erasmus Medical Centre

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan