A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)

Rigshospitalet

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00717717

PACT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Control

No Intervention group

Description:

No intervention except repeated measurements of physical capacity

Intervention

Experimental group

Description:

Intervention: One-year rehabilitation program including weekly supervised and group-based physical exercise, home-based physical activity, individual and group-based coaching (narrative therapy), and expert educational talks/lectures

Treatment:

Behavioral: Intervention