Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.oncorev.nl

Contact information

Type

Scientific

Primary contact

Dr A M May-de Groot

ORCID ID

Contact details

University Medical Center Utrecht
Julius Centrum
STR. 6.131
P.O. Box 85060
Utrecht
3508 AB
Netherlands
+31 (0)30 2539308
a.m.may@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR293

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/03/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

225

Participant 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)

Recruitment start date

15/03/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

Dutch Cancer Society and Maastricht University (The Netherlands)

Sponsor details

P.O. Box 75508
Amsterdam
1070 AM
Netherlands

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes