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

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717717
• Other study ID #: PACT
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: October 26, 2015
• Start date: November 2006
• Est. completion date: February 2012

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: February 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cancer Society, Velux Fonden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical fitness (VO2Max)		Baseline and follow-up (6, 12, 18, 24, and 36 months)	No
Secondary	Muscle strength (1RM) Cholesterol Quality of Life (cancer specific and health related) Anxiety & Depression Fatigue Coping Physical Activity behavior Health Behavior		Baseline and follow-up (6,12,18,24, and 36 months)	No

External Links

•   Official institutional website