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| Name | Class |
|---|---|
| Cancer Prevention Research Institute of Texas | OTHER |
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A randomized multi-component physical activity intervention for breast cancer survivors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Physical activity education |
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| Group 2 | Experimental | Physical activity education and facility access |
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| Group 3 | Experimental | Physical activity education and supervised exercise sessions |
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| Group 4 | Experimental | Physical activity education and self-monitoring (Fitbit) |
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| Group 5 | Experimental | Physical activity education and active living counseling |
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| Group 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity education | Behavioral | Participants will be given educational materials on how to increase physical activity levels. |
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| Measure | Description | Time Frame |
|---|---|---|
| Moderate-to-vigorous physical activity measured by Actigraph accelerometer | Measure physical activity at baseline and follow-up periods (3- and 6-months post-baseline) and assess percentage of survivors meeting physical activity guideline recommendations. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhukar H Trivedi, MD | UTSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37081460 | Derived | 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. | |
| 30021554 |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D001107 | Architectural Accessibility |
| ID | Term |
|---|---|
| D005160 | Facility Design and Construction |
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
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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.
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Physical activity education, facility access, and supervised exercise sessions |
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| Group 7 | Experimental | Physical activity education, facility access, and self-monitoring (Fitbit) |
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| Group 8 | Experimental | Physical activity education, facility access, and active living counseling |
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| Group 9 | Experimental | Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit) |
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| Group 10 | Experimental | Physical activity education, supervised exercise sessions, and active living counseling |
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| Group 11 | Experimental | Physical activity education, self-monitoring (Fitbit), and active living counseling |
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| Group 12 | Experimental | Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit) |
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| Group 13 | Experimental | Physical activity education, facility access, supervised exercise sessions, and active living counseling |
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| Group 14 | Experimental | Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling |
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| Group 15 | Experimental | Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling |
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| Group 16 | Experimental | Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling |
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| Facility access | Behavioral | Participants will receive at 6 month membership to a local fitness facility. |
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| Supervised exercise sessions | Behavioral | Participants will attend weekly supervised exercise sessions with an exercise interventionist. |
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| Self-monitoring (Fitbit) | Behavioral | Participants will be given a Fitbit to monitor their physical activity levels. |
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| Active living counseling | Behavioral | Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels. |
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| 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. |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |