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 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 trial start date
15/03/2004
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list