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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00717717
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : October 28, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cancer Behavioral: Intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2006
Primary Completion Date : February 2010
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Physical fitness (VO2Max) [ Time Frame: Baseline and follow-up (6, 12, 18, 24, and 36 months) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Julie Midtgaard, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00717717     History of Changes
Other Study ID Numbers: PACT
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

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