Promoting Activity in Cancer Survivors

NCT ID: NCT03060941

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2020-02-28

Brief Summary

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A randomized multi-component physical activity intervention for breast cancer survivors.

Detailed Description

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The research project is a study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors. Individuals meeting inclusion/exclusion criteria will be randomized to one of sixteen intervention groups for the 6 months. Intervention components will include print-based education, self-monitoring, Active Living counseling, supervised exercise sessions, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 13 and 25). Changes in physical activity will be assessed for each intervention group.

Conditions

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Physical Activity Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The 500 participants in the physical activity intervention will be randomly assigned to one of sixteen intervention groups (see Table below). Randomization will be stratified by clinical site. The randomization scheme will be conducted by the study statistician. The randomization scheme will consist of balanced blocks within each stratum, with block size will be varied and randomly permuted. Allocation will occur following completion of baseline assessments.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Physical activity education

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Group 2

Physical activity education and facility access

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Group 3

Physical activity education and supervised exercise sessions

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Group 4

Physical activity education and self-monitoring (Fitbit)

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Group 5

Physical activity education and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 6

Physical activity education, facility access, and supervised exercise sessions

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Group 7

Physical activity education, facility access, and self-monitoring (Fitbit)

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Group 8

Physical activity education, facility access, and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 9

Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit)

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Group 10

Physical activity education, supervised exercise sessions, and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 11

Physical activity education, self-monitoring (Fitbit), and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 12

Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Group 13

Physical activity education, facility access, supervised exercise sessions, and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 14

Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 15

Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Group 16

Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling

Group Type EXPERIMENTAL

Physical activity education

Intervention Type BEHAVIORAL

Participants will be given educational materials on how to increase physical activity levels.

Facility access

Intervention Type BEHAVIORAL

Participants will receive at 6 month membership to a local fitness facility.

Supervised exercise sessions

Intervention Type BEHAVIORAL

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Self-monitoring (Fitbit)

Intervention Type BEHAVIORAL

Participants will be given a Fitbit to monitor their physical activity levels.

Active living counseling

Intervention Type BEHAVIORAL

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Interventions

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Physical activity education

Participants will be given educational materials on how to increase physical activity levels.

Intervention Type BEHAVIORAL

Facility access

Participants will receive at 6 month membership to a local fitness facility.

Intervention Type BEHAVIORAL

Supervised exercise sessions

Participants will attend weekly supervised exercise sessions with an exercise interventionist.

Intervention Type BEHAVIORAL

Self-monitoring (Fitbit)

Participants will be given a Fitbit to monitor their physical activity levels.

Intervention Type BEHAVIORAL

Active living counseling

Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* breast cancer survivors between 3 months and 5 years post-treatment
* report \<150 minutes of moderate-to-vigorous physical activity (MVPA) on the GPAQ
* physically able to engage in physical activity

Exclusion Criteria

* medical condition contraindicating physical activity participation
* cognitively unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Madhukar H. Trivedi, MD

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhukar H Trivedi, MD

Role: PRINCIPAL_INVESTIGATOR

UTSW

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Rethorst CD, Carmody TJ, Argenbright KE, Mayes TL, Hamann HA, Trivedi MH. Considering depression as a secondary outcome in the optimization of physical activity interventions for breast cancer survivors in the PACES trial: a factorial randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Apr 20;20(1):47. doi: 10.1186/s12966-023-01437-x.

Reference Type DERIVED
PMID: 37081460 (View on PubMed)

Rethorst CD, Hamann HA, Carmody TJ, Sharp KJ, Argenbright KE, Haley BB, Skinner CS, Trivedi MH. The Promoting Activity in Cancer Survivors (PACES) trial: a multiphase optimization of strategy approach to increasing physical activity in breast cancer survivors. BMC Cancer. 2018 Jul 18;18(1):744. doi: 10.1186/s12885-018-4662-5.

Reference Type DERIVED
PMID: 30021554 (View on PubMed)

Other Identifiers

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STU 092016-004

Identifier Type: -

Identifier Source: org_study_id

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