Clinical trial NCT00717717: A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)
Official title: Physical Activity After Cancer Treatment (PACT)- A Clinical Controlled Trial on the Effect of a One-year Physical Activity Program for Cancer Patients Following Cytostatic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer Survivor
Physical Activity
Health Behavior
Psychosocial Well-being
Coaching
Long Term
Consequences
Chemotherapy
Motivation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Danish Cancer Society
First posted: 2008-07-17
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field of cancer rehabilitation in Denmark. It differs from other studies mainly due to the intervention itself. A combination of physiological, health educational and therapeutic elements will be tested. These components are incorporated into a one-year training program for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to enhance their well.-being and quality of life. The overall aim of this approach is to place increased focus on the treated cancer patient's introduction to and exploitation of both physiological and psychosocial yields through physical exercise. Whether or not the study results bear a positive effect, they are expected to support new knowledge in rehabilitation for cancer survivors.

Detailed description: The PACT ('Physical Activity after Cancer Treatment') Study is a multidisciplinary collaborative study carried out by the University Hospitals Centre for Nursing and Care Research (UCSF) and the Finsen Center (Oncology and Hematology Clinics) of the Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark. The project draws in cancer patients who have undergone chemotherapy and who are now disease-free or at a stable phase in their illness and have good prognoses.

The aim of the study is to investigate the effect of a 12-month rehabilitation program comprising supervised and structured physical exercise training (body conditioning; strength-building; relaxation; massage), patient education and coaching combined with a home-based physical exercise group component and will include a control group. Groups of 12-15 patients will be formed (mixed genders; different oncological and hematological diagnoses) who will train together once weekly during the intervention period. Participation in a training program with peers is seen as a positive motivational factor that stimulates and challenges the patient through physical activity, to use his/her own resources to establish sustainable coping strategies.

Eligibility criteria: Inclusion Criteria:

* Cancer diagnosis
* Completed cytostatic treatment \<6 months
* Affiliated with either the Oncology or Hematology Clinic at the Copenhagen University Hospital, Copenhagen
* Between the ages of 15-70 years
* No evidence of disease or life expectancy \>2 years.

Exclusion Criteria:

* Contraindications for physical activity
* Bone and brain metastases
* Multiple myeloma (in the case of hematological patients)
* Symptomatic cardiac illness, including clinical congestive heart disease, treatment caused arrhythmia or myocardial infarction experienced within the previous three months
* Dementia and/or psychosis
* Patients who cannot read or write Danish.

Primary outcomes:
measure: Physical fitness (VO2Max)
timeFrame: Baseline and follow-up (6, 12, 18, 24, and 36 months)
Secondary outcomes:
measure: Muscle strength (1RM) Cholesterol Quality of Life (cancer specific and health related) Anxiety & Depression Fatigue Coping Physical Activity behavior Health Behavior
timeFrame: Baseline and follow-up (6,12,18,24, and 36 months)
Other outcomes:
Locations:
Study officials:
affiliation: The University Hospitals Centre for Nursing and Care Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)
name: Julie Midtgaard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, Copenhagen University Hospital
name: Mikael Rørth, PhD
role: STUDY_DIRECTOR
affiliation: The University Hospitals Centre for Nursing and Care Research (UCSF) / Copenhagen University Hospital
name: Lis Adamsen, Professor
role: STUDY_DIRECTOR
References: