NCT00717717

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

3.3 years

First QC Date

July 15, 2008

Last Update Submit

October 26, 2015

Conditions

Keywords

Cancer SurvivorPhysical ActivityHealth BehaviorPsychosocial Well-beingCoachingLong TermConsequencesChemotherapyMotivation

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 INTERVENTION

No intervention except repeated measurements of physical capacity

Intervention

EXPERIMENTAL

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

Interventions

InterventionBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Related Links

MeSH Terms

Conditions

NeoplasmsMotor ActivityHealth Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Julie Midtgaard, PhD

    The University Hospitals Centre for Nursing and Care Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)

    PRINCIPAL INVESTIGATOR
  • 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 DIRECTOR

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