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OncoRev study.

Effect of a multi-disciplinary rehabilitation program for cancer patients on quality of life: a randomised controlled multicenter trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22705
Enrollment
225
Registered
2005-09-09
Start date
2004-03-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

1. 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).

Sponsors

KWF Universiteit Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

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 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).

Design outcomes

Primary

MeasureTime frame
Quality of life.

Secondary

MeasureTime frame
1. 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.

Contacts

Public ContactA.M. May-deGroot

University Medical Center Utrecht (UMCU), Julius Centrum, STR. 6.131, P.O. Box 85060

a.may@med.uu.nl+31 (0)30 2539308

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)