Breast CancerSABCNCT06052488
Strength After Breast Cancer
A study testing Strength After Breast Cancer in people with Breast Cancer, run by MGH Institute of Health Professions at 1 site in United States.
Trial summary
The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Strength After Breast Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years of age
- Diagnosed with Stage I-III breast cancer, having completed primary cancer treatment (e.g., surgery, chemotherapy, radiation therapy); hormonal therapies and adjuvant targeted therapies will be permitted
Who cannot join
- Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathleen Lyons, ScD, OTR/L contact
United States1 site, 1 recruiting
- Recruiting
MGH Institute of Health Professions
Boston, Massachusetts, 02129
Stephen Wechsler, DPT, PhD, 774-217-3221, swechsler@mghihp.edu
About this study
Official title: Strength After Breast Cancer: Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors
The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer.
The main questions this study aims to answer are:
Read more
- Can the Strength After Breast Cancer program and the associated outcome battery be successfully delivered in an outpatient physical therapy clinic at Massachusetts General Hospital and do participants find the program practical?
- What are the barriers to and facilitators of delivering the group exercise program in a clinical setting and what changes need to be made to the program to improve sustainability and to facilitate implementation at other clinical sites?
Participants will complete study questionnaires before and after engaging in the group exercise program and they will participate in interviews following participation in the program.
Read the detailed description
The goal of this single arm feasibility study of the Strength After Breast Cancer (SABC) evidence-based group exercise intervention for women after treatment for breast cancer is to determine if investigators can feasibly deliver the program out of the outpatient physical therapy clinic at Massachusetts General Hospital Waltham.
- Following a one-on-one physical therapy evaluation, the four-session SABC program provides a group-based but individualized exercise plan and encourages engagement in independent home-based exercises to improve physical function. The SABC program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer. Therefore, the focus of this study is to explore clinical implementation barriers, facilitators, and necessary program adaptations to enhance sustainability and facilitate implementation at other clinical sites.
Study procedures include screening for eligibility, in-clinic visits, questionnaires, and a semi-structured interview.
Participation in this research study is expected to last up to 5 months. It is expected that up to 40 people will take part in this research study.
This is an unfunded study.
- Conditions
- Breast Cancer
- Being tested
- Strength After Breast Cancer
- Keywords
- Physical Therapy, Exercise Program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength After Breast CancerBehavioural
Individual physical therapy evaluation and 4 group-based exercise sessions led by a licensed physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Strength After Breast Cancer (SABC) Intervention | Experimental | Participants will undergo study procedures as outlined:
* Complete a baseline survey regarding exercise self-efficacy, physical activity level, quality of life, and fatigue
* Attend a 1-on-1 physical therapy evaluation and 4 group exercise sessions at MGH Waltham
* After completing the 4 exercise sessions, complete follow-up surveys including a program satisfaction survey
* At 1-month post-program, complete follow-up surveys and an individual, semi-structured interview with study staff to supply feedback about the program.
* At 3-months post-program, complete follow-up surveys Receives: Behavioral: Strength After Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Rate
Number patients screened / Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility.
Measured: At screening
Eligibility Rate
Number patients screening eligible / Number screened. Eligibility rate of at least 75% will indicate feasibility.
Measured: At screening
Enrollment Rate
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
Measured: At screening
Program completion rate
Number participants completing 4 sessions of the SABC intervention / Number of participants enrolled. For this study, the investigators will consider it feasible if 75% of participants complete all 4 sessions.
Measured: Up to 2 months
Intervention session completion rate
Number of completed sessions per participant. For this study, the investigators will consider it feasible if the mean number of sessions completed per participant is ≥ 3.
Measured: Up to 2 months
Assessment completion rate
Number participants completing each of the 4 study assessments / Number of participants enrolled. For this study, an assessment completion rate of 75% will indicate feasibility.
Measured: Up to 5 months
Secondary outcomes (5)
Participant Satisfaction
Assessed by the post-program satisfaction survey which is a 7-item survey that is rated on a 5-point Likert scale; total score range 7-35 (higher score indicates greater satisfaction). Any item on the Satisfaction survey that generates a mean score of < 4 will trigger consideration of modification to the SABC program.
Measured: Up to 2 months
Exercise Self-Efficacy
Assessed with the Self-Efficacy with Exercise scale which consists of nine potential exercise barriers and asks the individual to rate their confidence on a 0 (not confident) - 10 (very confident) scale that they could exercise for twenty minutes, three times per week, given each barrier (total score range 0-90; maximum score of 90 indicates highest exercise self-efficacy).
Measured: Up to 5 months
Physical Activity Level
Assessed using the International Physical Activity Questionnaire Long Form to assess duration and frequency of physical activity in the last seven days in domains of: job-related, transportation, housework/house maintenance/caring for family, recreation/sport/leisure-time, and time spent sitting.
Measured: Up to 5 months
Quality of Life: Functional Assessment of Cancer Therapy - General
Assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) (28 items), which measures health-related quality of life covering four domains of well-being (physical, social/family, emotional, functional). This measure is included in and will be assessed as part of The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Total score range for FACT-G is 0-108 with higher scores indicating greater quality of life.
Measured: Up to 5 months
Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale
Assessed using the Functional Assessment of Chronic Illness Treatment - Fatigue (FACIT-F), 13 item fatigue subscale. Total score for 13-item fatigue subscale is 0-52 with higher score indicating worse fatigue.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start2 Jan 2024
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wechsler, MGH Institute of Health Professions
- Investigators
- Stephen Wechsler, DPT, PhD, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052488
- Sponsor's protocol ID
- 23-418
- Acronym
- SABC
- Status last verified
- Oct 2025
- First submitted
- 12 Sep 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: the Partners Innovations team at http://www.partners.org/innovation. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength After Breast Cancer: Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06052488
- Acronym / sponsor ID
- SABC / 23-418
- Conditions
- Breast Cancer
- Keywords
- Physical Therapy, Exercise Program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Sep 2023 (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.
The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer.
The main questions this study aims to answer are:
- Can the Strength After Breast Cancer program and the associated outcome battery be successfully delivered in an outpatient physical therapy clinic at Massachusetts General Hospital and do participants find the program practical?
- What are the barriers to and facilitators of delivering the group exercise program in a clinical setting and what changes need to be made to the program to improve sustainability and to facilitate implementation at other clinical sites?
Participants will complete study questionnaires before and after engaging in the group exercise program and they will participate in interviews following participation in the program.
Detailed description
The goal of this single arm feasibility study of the Strength After Breast Cancer (SABC) evidence-based group exercise intervention for women after treatment for breast cancer is to determine if investigators can feasibly deliver the program out of the outpatient physical therapy clinic at Massachusetts General Hospital Waltham.
- Following a one-on-one physical therapy evaluation, the four-session SABC program provides a group-based but individualized exercise plan and encourages engagement in independent home-based exercises to improve physical function. The SABC program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer. Therefore, the focus of this study is to explore clinical implementation barriers, facilitators, and necessary program adaptations to enhance sustainability and facilitate implementation at other clinical sites.
Study procedures include screening for eligibility, in-clinic visits, questionnaires, and a semi-structured interview.
Participation in this research study is expected to last up to 5 months. It is expected that up to 40 people will take part in this research study.
This is an unfunded study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strength After Breast Cancer (SABC) Intervention | Experimental | Behavioral: Strength After Breast CancerParticipants will undergo study procedures as outlined: * Complete a baseline survey regarding exercise self-efficacy, physical activity level, quality of life, and fatigue * Attend a 1-on-1 physical therapy evaluation and 4 group exercise sessions at MGH Waltham * After completing the 4 exercise sessions, complete follow-up surveys including a program satisfaction survey * At 1-month post-program, complete follow-up surveys and an individual, semi-structured interview with study staff to supply feedback about the program. * At 3-months post-program, complete follow-up surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- Diagnosed with Stage I-III breast cancer, having completed primary cancer treatment (e.g., surgery, chemotherapy, radiation therapy); hormonal therapies and adjuvant targeted therapies will be permitted
Key exclusion criteria (2 listed)
- Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
- Non-English speaking
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 |
|---|---|---|
| Strength After Breast CancerIndividual physical therapy evaluation and 4 group-based exercise sessions led by a licensed physical therapist | Behavioural | Strength After Breast Cancer (SABC) Intervention |
Primary outcome
Screening Rate
Time frame: At screening
Number patients screened / Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility.
Eligibility Rate
Time frame: At screening
Number patients screening eligible / Number screened. Eligibility rate of at least 75% will indicate feasibility.
Enrollment Rate
Time frame: At screening
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
Program completion rate
Time frame: Up to 2 months
Number participants completing 4 sessions of the SABC intervention / Number of participants enrolled. For this study, the investigators will consider it feasible if 75% of participants complete all 4 sessions.
Intervention session completion rate
Time frame: Up to 2 months
Number of completed sessions per participant. For this study, the investigators will consider it feasible if the mean number of sessions completed per participant is ≥ 3.
Assessment completion rate
Time frame: Up to 5 months
Number participants completing each of the 4 study assessments / Number of participants enrolled. For this study, an assessment completion rate of 75% will indicate feasibility.
5 secondary outcomes
Participant Satisfaction
Time frame: Up to 2 months
Exercise Self-Efficacy
Time frame: Up to 5 months
Physical Activity Level
Time frame: Up to 5 months
Quality of Life: Functional Assessment of Cancer Therapy - General
Time frame: Up to 5 months
Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale
Time frame: Up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: the Partners Innovations team at http://www.partners.org/innovation. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Kathleen Lyons, ScD, OTR/L contact
Stephen Wechsler, DPT, PhD principal investigator
MGH Institute of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength After Breast Cancer in people with Breast Cancer, run by MGH Institute of Health Professions 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 2 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: looking for participants now, as of the sponsor's last update on 20 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Wechsler, DPT, PhD (774-217-3221, swechsler@mghihp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Rate (time frame: At screening). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2025.