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
Contact information
Dr A M May-de Groot
Scientific
Scientific
University Medical Center Utrecht
Julius Centrum
STR. 6.131
P.O. Box 85060
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 2539308 |
|---|---|
| a.m.may@umcutrecht.nl |
Study information
| Study design | Multicentre, randomised, single blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Multidisciplinary 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) studied | Cancer |
| Intervention | 1. 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 type | Other |
| Primary outcome measure | Quality of life |
| Secondary outcome measures | 1. 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 date | 15/03/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 225 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 15/03/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
Dutch Cancer Society and Maastricht University (The Netherlands)
Charity
Charity
P.O. Box 75508
Amsterdam
1070 AM
Netherlands
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
