A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)
PACT
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
1 other identifier
interventional
214
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Nov 2006
Longer than P75 for not_applicable cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 15, 2008
CompletedFirst Posted
Study publicly available on registry
July 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedOctober 28, 2015
October 1, 2015
3.3 years
July 15, 2008
October 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical fitness (VO2Max)
Baseline and follow-up (6, 12, 18, 24, and 36 months)
Secondary Outcomes (1)
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)
Study Arms (2)
Control
NO INTERVENTIONNo intervention except repeated measurements of physical capacity
Intervention
EXPERIMENTALIntervention: 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Velux Fondencollaborator
- Danish Cancer Societycollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 15, 2008
First Posted
July 17, 2008
Study Start
November 1, 2006
Primary Completion
February 1, 2010
Study Completion
February 1, 2012
Last Updated
October 28, 2015
Record last verified: 2015-10