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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN68530111
• Date of registration: 20/12/2005
• Prospective Registration: No
• Primary sponsor: Dutch Cancer Society and Maastricht University (The Netherlands)
• Public title: OncoRev study: effect of a multi-disciplinary rehabilitation program for cancer patients on quality of life - a randomised controlled multicentre trial
• Date of first enrolment: 15/03/2004
• Target sample size: 225
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN68530111
• Study type: Interventional
• Study design: Multicentre, randomised, single blind, placebo controlled, parallel group trial (Treatment)

Countries of recruitment

Netherlands

Contacts

• Name: A M May-de Groot

Key inclusion & exclusion criteria

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
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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer
Cancer
Malignant neoplasm without specification of site

Intervention(s)

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)

Primary Outcome(s)

Quality of life

Secondary Outcome(s)

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

Secondary ID(s)

NTR293

Source(s) of Monetary Support

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