Physical ActivityPACESNCT03060941
Promoting Activity in Cancer Survivors
A study testing Physical activity education, Facility access and Supervised exercise sessions in people with Physical Activity and Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
A randomized multi-component physical activity intervention for breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Activity, Breast Cancer
- What is being tested?
- Physical activity education, Facility access and Supervised exercise sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- medical condition contraindicating physical activity participation
- cognitively unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
A randomized multi-component physical activity intervention for breast cancer survivors.
Read the detailed description
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
- Physical Activity, Breast Cancer
- Being tested
- Physical activity education, Facility access, Supervised exercise sessions, Self-monitoring (Fitbit), Active living counseling
- Medical subject headings
- Motor Activity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity educationBehavioural
Participants will be given educational materials on how to increase physical activity levels.
Facility accessBehavioural
Participants will receive at 6 month membership to a local fitness facility.
Supervised exercise sessionsBehavioural
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Self-monitoring (Fitbit)Behavioural
Participants will be given a Fitbit to monitor their physical activity levels.
Active living counselingBehavioural
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Physical activity education Receives: Behavioral: Physical activity education |
| Group 2 | Experimental | Physical activity education and facility access Receives: Behavioral: Physical activity education; Behavioral: Facility access |
| Group 3 | Experimental | Physical activity education and supervised exercise sessions Receives: Behavioral: Physical activity education; Behavioral: Supervised exercise sessions |
| Group 4 | Experimental | Physical activity education and self-monitoring (Fitbit) Receives: Behavioral: Physical activity education; Behavioral: Self-monitoring (Fitbit) |
| Group 5 | Experimental | Physical activity education and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Active living counseling |
| Group 6 | Experimental | Physical activity education, facility access, and supervised exercise sessions Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Supervised exercise sessions |
| Group 7 | Experimental | Physical activity education, facility access, and self-monitoring (Fitbit) Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Self-monitoring (Fitbit) |
| Group 8 | Experimental | Physical activity education, facility access, and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Active living counseling |
| Group 9 | Experimental | Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit) Receives: Behavioral: Physical activity education; Behavioral: Supervised exercise sessions; Behavioral: Self-monitoring (Fitbit) |
| Group 10 | Experimental | Physical activity education, supervised exercise sessions, and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Supervised exercise sessions; Behavioral: Active living counseling |
| Group 11 | Experimental | Physical activity education, self-monitoring (Fitbit), and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Self-monitoring (Fitbit); Behavioral: Active living counseling |
| Group 12 | Experimental | Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit) Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Supervised exercise sessions; Behavioral: Self-monitoring (Fitbit) |
| Group 13 | Experimental | Physical activity education, facility access, supervised exercise sessions, and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Supervised exercise sessions; Behavioral: Active living counseling |
| Group 14 | Experimental | Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Self-monitoring (Fitbit); Behavioral: Active living counseling |
| Group 15 | Experimental | Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Supervised exercise sessions; Behavioral: Self-monitoring (Fitbit); Behavioral: Active living counseling |
| Group 16 | Experimental | Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling Receives: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Supervised exercise sessions; Behavioral: Self-monitoring (Fitbit); Behavioral: Active living counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start4 Dec 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar H Trivedi, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060941
- Sponsor's protocol ID
- STU 092016-004
- Acronym
- PACES
- Status last verified
- Jan 2021
- First submitted
- 17 Feb 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37081460Rethorst 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.
PubMed 30021554
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Activity in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03060941
- Acronym / sponsor ID
- PACES / STU 092016-004
- Conditions
- Physical Activity, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized multi-component physical activity intervention for breast cancer survivors.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Physical activity educationPhysical activity education |
| Group 2 | Experimental | Behavioral: Physical activity education, Behavioral: Facility accessPhysical activity education and facility access |
| Group 3 | Experimental | Behavioral: Physical activity education, Behavioral: Supervised exercise sessionsPhysical activity education and supervised exercise sessions |
| Group 4 | Experimental | Behavioral: Physical activity education, Behavioral: Self-monitoring (Fitbit)Physical activity education and self-monitoring (Fitbit) |
| Group 5 | Experimental | Behavioral: Physical activity education, Behavioral: Active living counselingPhysical activity education and active living counseling |
| Group 6 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Supervised exercise sessionsPhysical activity education, facility access, and supervised exercise sessions |
| Group 7 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Self-monitoring (Fitbit)Physical activity education, facility access, and self-monitoring (Fitbit) |
| Group 8 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Active living counselingPhysical activity education, facility access, and active living counseling |
| Group 9 | Experimental | Behavioral: Physical activity education, Behavioral: Supervised exercise sessions, Behavioral: Self-monitoring (Fitbit)Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit) |
| Group 10 | Experimental | Behavioral: Physical activity education, Behavioral: Supervised exercise sessions, Behavioral: Active living counselingPhysical activity education, supervised exercise sessions, and active living counseling |
| Group 11 | Experimental | Behavioral: Physical activity education, Behavioral: Self-monitoring (Fitbit), Behavioral: Active living counselingPhysical activity education, self-monitoring (Fitbit), and active living counseling |
| Group 12 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Supervised exercise sessions, Behavioral: Self-monitoring (Fitbit)Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit) |
| Group 13 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Supervised exercise sessions, Behavioral: Active living counselingPhysical activity education, facility access, supervised exercise sessions, and active living counseling |
| Group 14 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Self-monitoring (Fitbit), Behavioral: Active living counselingPhysical activity education, facility access, self-monitoring (Fitbit), and active living counseling |
| Group 15 | Experimental | Behavioral: Physical activity education, Behavioral: Supervised exercise sessions, Behavioral: Self-monitoring (Fitbit), Behavioral: Active living counselingPhysical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling |
| Group 16 | Experimental | Behavioral: Physical activity education, Behavioral: Facility access, Behavioral: Supervised exercise sessions, Behavioral: Self-monitoring (Fitbit), Behavioral: Active living counselingPhysical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- medical condition contraindicating physical activity participation
- cognitively unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity educationParticipants will be given educational materials on how to increase physical activity levels. | Behavioural | Group 1, Group 10, Group 11, Group 12, Group 13, Group 14, Group 15, Group 16, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8, Group 9 |
| Facility accessParticipants will receive at 6 month membership to a local fitness facility. | Behavioural | Group 12, Group 13, Group 14, Group 16, Group 2, Group 6, Group 7, Group 8 |
| Supervised exercise sessionsParticipants will attend weekly supervised exercise sessions with an exercise interventionist. | Behavioural | Group 10, Group 12, Group 13, Group 15, Group 16, Group 3, Group 6, Group 9 |
| Self-monitoring (Fitbit)Participants will be given a Fitbit to monitor their physical activity levels. | Behavioural | Group 11, Group 12, Group 14, Group 15, Group 16, Group 4, Group 7, Group 9 |
| Active living counselingParticipants will attend 12 biweekly educational sessions about how to increase their physical activity levels. | Behavioural | Group 10, Group 11, Group 13, Group 14, Group 15, Group 16, Group 5, Group 8 |
Primary outcome
Moderate-to-vigorous physical activity measured by Actigraph accelerometer
Time frame: 24 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 37081460Rethorst 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.
- Derived from this study: PubMed 30021554Rethorst 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar H Trivedi, MD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity education, Facility access and Supervised exercise sessions in people with Physical Activity and Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-vigorous physical activity measured by Actigraph accelerometer (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060941, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.