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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Velux Fonden
Danish Cancer Society
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00717717
First received: July 15, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Intervention

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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Physical fitness (VO2Max) [ Time Frame: Baseline and follow-up (6, 12, 18, 24, and 36 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength (1RM) Cholesterol Quality of Life (cancer specific and health related) Anxiety & Depression Fatigue Coping Physical Activity behavior Health Behavior [ Time Frame: Baseline and follow-up (6,12,18,24, and 36 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: November 2006
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No intervention except repeated measurements of physical capacity
Experimental: Intervention
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
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717717

Sponsors and Collaborators
Rigshospitalet, Denmark
Velux Fonden
Danish Cancer Society
Investigators
Principal Investigator: Julie Midtgaard, PhD The University Hospitals Centre for Nursing and Care Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)
Study Director: Mikael Rørth, PhD Department of Oncology, Copenhagen University Hospital
Study Director: Lis Adamsen, Professor The University Hospitals Centre for Nursing and Care Research (UCSF) / Copenhagen University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Julie Midtgaard, PhD, The University Hospitals Centre for Nursing and Care Research (UCSF)
ClinicalTrials.gov Identifier: NCT00717717     History of Changes
Other Study ID Numbers: PACT
Study First Received: July 15, 2008
Last Updated: September 17, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Cancer Survivor
Physical Activity
Health Behavior
Psychosocial Well-being
Coaching
Long Term
Consequences
Chemotherapy
Motivation

ClinicalTrials.gov processed this record on October 21, 2014