Breast NeoplasmsNCT07489053
Optimizing Functional Recovery After Breast Cancer Treatment
A study testing Individually tailored education and guided application to promote activity participation, Individually tailored guided application and Individually tailored education in people with Breast Neoplasms, run by MGH Institute of Health Professions at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine the best way to promote participation in vocational, social, physical, and instrumental activities of daily living in people who have completed treatment for early stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Individually tailored education and guided application to promote activity participation, Individually tailored guided application and Individually tailored education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2030
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older,
- Diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or adjuvant therapy with curative intent and absence of disease recurrence,
- Experiencing reduced participation (i.e., a score of > 10 on the Work and Social Adjustment Scale).
Who cannot join
- Non-English speaking.
- Non-correctable hearing loss.
- Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
- History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MGH Institute of Health Professions
Boston, Massachusetts, 02129
Sheel Singh, MA, 617-724-9835, ssingh@mghihp.edu
Kathleen Lyons, ScD, 617-643-5372, carelab@partners.org
About this study
Official title: Optimization of a Multicomponent Intervention to Foster Functional Recovery After Breast Cancer Treatment
The goal of this clinical trial is to determine the best way to promote participation in vocational, social, physical, and instrumental activities of daily living in people who have completed treatment for early stage breast cancer.
The main question it aims to answer is: Which of the intervention components, alone or in combination, most effectively promote participation in vocational, social, physical, and instrumental activities of daily living?
Participants will be asked to try one of 8 combination of three intervention components that have been shown to promote activity participation: (1) priority elicitation, (2) education, and (3) guided application involving goal setting, problem-solving and action planning.
Read the detailed description
Breast cancer treatment creates physical, emotional, and practical challenges that disrupt routines and activities. After completion of curative treatment, one-third of cancer survivors report participation restrictions, defined as difficulties performing valued activities that reflect life roles. Participation restrictions can persist two to six years after breast cancer treatment, imposing personal and societal costs by hindering one's ability to fulfill career, civic, and caregiving roles. Addressing participation restrictions reflects the Cancer Moonshot Initiative call for research on ways to reduce the debilitating effects of cancer, yet there are no evidence-based interventions that are ready for large scale implementation.
Most survivorship research has targeted symptom management, yet that does not always translate into greater participation in role-relevant activities. Recent evidence demonstrates that participation can be enhanced even in the absence of symptom reduction. There are now a number of interventions that aim to increase participation through various combinations of self-management strategies like goal setting and problem-solving, priority elicitation, and education about activity adaptation, environmental modification, and energy management. While studies indicate that these strategies are feasible and appear to enhance participation, each study uses a different blend of strategies that are often not well-specified, creating uncertainty as to which strategies of the multi-component interventions are most potent and which may be unnecessary. This uncertainty reduces reproducibility and limits large-scale implementation.
The goal of this study is to identify mechanisms of action that reliably enhance participation in role-relevant activities after breast cancer treatment. The Multiphase Optimization STrategy (MOST) framework of intervention development uses engineering principles to build multi-component interventions that are both potent (i.e., produce clinically relevant outcomes) and parsimonious (i.e., contain no inactive ingredients). The first phase of MOST creates a conceptual model linking intervention components (i.e., strategies) and the intended targets and identifies an optimization criterion by which success will be judged. This study's optimization criterion is to find the combination of intervention components that has the largest effect on participation restrictions. This proposal reflects the second phase of MOST, the optimization phase, where the investigators will evaluate the degree to which each intervention component exerts an independent or synergistic effect on participation restrictions. The optimization phase ensures that the resulting intervention is composed only of components that are contributing to the outcome of interest.
This study will use a factorial experiment to test three intervention components that have been used with breast cancer survivors: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning. The components each have a modest evidence base supporting their efficacy to reduce participation restrictions. However, they have different profiles regarding a) the time survivors need to invest and b) the skills practitioners need to successfully deliver. To move the science forward, it is crucial to develop a potent yet parsimonious intervention with empirically-supported mechanisms of action.
This study's research question is: Which components alone or in combination have the greatest impact on participation restrictions? Using the MOST framework, the investigators will conduct an optimization trial with a factorial design. The investigators will recruit 352 breast cancer survivors reporting participation restrictions in the first year following curative treatment; participants will be randomized to receive combinations of the 3 components.
Aim 1: To identify the intervention components that reduce participation restrictions (primary outcome). Intervention components: a) priority elicitation (priority-elicitation coaching versus following a static menu of goals and topics); b) cancer survivorship education (therapist-administered versus weblink); and c) guided application (included versus not). Criterion: A component will be considered effective if its presence produces a main or interaction effect of Cohen's d of > 0.30.
Aim 2: To test the conceptual model by determining the degree to which each intervention component affects the following proximal targets: H1: Priority elicitation will have the strongest effect on engagement in valued activities. H2: Cancer survivorship education will have the strongest effect on self-efficacy for managing health. H3: Guided application will have the strongest effect on adaptive coping.
Aim 3: To assemble an intervention package by evaluating the main effects and interactions with the following optimization criterion: The largest effect on participation restrictions.
- Conditions
- Breast Neoplasms
- Being tested
- Individually tailored education and guided application to promote activity participation, Individually tailored guided application, Individually tailored education, Priority elicitation, Static education and guided application
- Keywords
- randomized controlled trial, factorial experiment, rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually tailored education and guided application to promote activity participationBehavioural
This condition has high levels of the three components: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning.
Individually tailored guided applicationBehavioural
This condition contains high levels of priority elicitation and guided application.
Individually tailored educationBehavioural
This condition contains how levels of the components of priority elicitation and education
Priority elicitationBehavioural
This condition contains the high level of the priority elicitation component
Static education and guided applicationBehavioural
This condition has high levels of the education and guided application components
Static guided applicationBehavioural
This condition contains high level of the guided application component
Static educationBehavioural
This condition contains the high level of the education component
InformationBehavioural
This condition contains the low levels of the three components
| Study group | Role | What they receive |
|---|---|---|
| Priority elicitation, education, and guided application | Experimental | Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information and set goals and action plans that are tailored to personal priorities Receives: Behavioral: Individually tailored education and guided application to promote activity participation |
| Priority elicitation and guided application | Experimental | Weekly telephone or videoconference sessions with a coach where participants will set goals and action plans that are tailored to personal priorities; survivorship information tailored to personal priorities will be emailed to participants Receives: Behavioral: Individually tailored guided application |
| Priority elicitation and education | Experimental | Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities Receives: Behavioral: Individually tailored education |
| Priority elicitation | Experimental | Telephone or videoconference sessions with a coach in the first and last week where participants will discuss personal priorities for recovery; survivorship information tailored to personal priorities will be emailed to participants each week Receives: Behavioral: Priority elicitation |
| Education and guided application | Experimental | Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information and set goals and action plans from a static menu of six different topics Receives: Behavioral: Static education and guided application |
| Guided application | Experimental | Weekly telephone or videoconference sessions with a coach where participants will set goals and action plans from a static menu of six different topics; survivorship information from a static menu of six different topics will be emailed to participants each week Receives: Behavioral: Static guided application |
| Education | Experimental | Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics Receives: Behavioral: Static education |
| Information | Experimental | Weekly survivorship education will be emailed to participants, from a static menu of six different topics Receives: Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation satisfaction: PROMIS Satisfaction with Social Roles and Activities Short Form 8a
Scores range from 8 to 40, with higher values representing greater satisfaction with ability to participate in social roles and activities.
Measured: Baseline to week 20
Secondary outcomes (4)
Participation ability: Ability to Participate in Social Roles and Activities Short Form 8a
Scores range from 8 to 40, with lower values representing greater difficulty participating in social roles and activities
Measured: Baseline to 20 weeks
Valuing Questionnaire: Engagement in valued activities
Two subscales of five items each. Progress subscale ranges from 0 to 30 with high scores reflecting better concordance between values and actions. Obstruction subscale ranges from 0 to 30 with high scores reflecting more interference between values and actions.
Measured: Baseline to 20 weeks
Self-efficacy for health management: Self-Efficacy for Managing Chronic Disease Scale
Scores range from 6 to 60 with higher scores indicating higher self-efficacy
Measured: Baseline to 20 weeks
Adaptive coping: Brief COPE subscales
Three subscales of the Brief COPE: planning, active coping, and positive reframing. Scores on each subscale are calculated as the sum of two items, thus possible scores range from 0 to 6, with higher values representing greater use of active coping strategies.
Measured: Baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized 2X3 factorial experiment reflecting the optimization phase of the Multiphase Optimization Strategy (MOST) Framework
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of South Alabama, Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Kathleen Lyons, ScD, OTR/L, MGH Institute of Health Professions
- Investigators
- Kathleen D Lyons, ScD, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489053
- Sponsor's protocol ID
- 2026P000285
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is expected to generate qualitative and quantitative data from up to 352 people who have finished treatment for Stage 1-3 breast cancer within the past year). Qualitative data include answers to open-ended questions about the acceptability and utility of the intervention components. Qualitative data also include the treatment session documentation (e.g., topics of goals set, education delivered). Quantitative data include participant characteristics (e.g., age, gender, type of treatment, marital status) and answers to the survey outcome assessments of participation restrictions, adaptive coping, meaningful activity engagement, and self-efficacy. All raw and scored quantitative data will be de-identified, preserved, and made publicly available for at least 7 years post-publication of findings. The qualitative data (which is harder to de-identify and may contain sensitive information that the disclosure of which could negatively affect participants) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Multicomponent Intervention to Foster Functional Recovery After Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT07489053
- Acronym / sponsor ID
- 2026P000285
- Conditions
- Breast Neoplasms
- Keywords
- randomized controlled trial, factorial experiment, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of South Alabama, Dartmouth-Hitchcock Medical Center
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 23 Mar 2026 (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 clinical trial is to determine the best way to promote participation in vocational, social, physical, and instrumental activities of daily living in people who have completed treatment for early stage breast cancer.
The main question it aims to answer is: Which of the intervention components, alone or in combination, most effectively promote participation in vocational, social, physical, and instrumental activities of daily living?
Participants will be asked to try one of 8 combination of three intervention components that have been shown to promote activity participation: (1) priority elicitation, (2) education, and (3) guided application involving goal setting, problem-solving and action planning.
Detailed description
Breast cancer treatment creates physical, emotional, and practical challenges that disrupt routines and activities. After completion of curative treatment, one-third of cancer survivors report participation restrictions, defined as difficulties performing valued activities that reflect life roles. Participation restrictions can persist two to six years after breast cancer treatment, imposing personal and societal costs by hindering one's ability to fulfill career, civic, and caregiving roles. Addressing participation restrictions reflects the Cancer Moonshot Initiative call for research on ways to reduce the debilitating effects of cancer, yet there are no evidence-based interventions that are ready for large scale implementation.
Most survivorship research has targeted symptom management, yet that does not always translate into greater participation in role-relevant activities. Recent evidence demonstrates that participation can be enhanced even in the absence of symptom reduction. There are now a number of interventions that aim to increase participation through various combinations of self-management strategies like goal setting and problem-solving, priority elicitation, and education about activity adaptation, environmental modification, and energy management. While studies indicate that these strategies are feasible and appear to enhance participation, each study uses a different blend of strategies that are often not well-specified, creating uncertainty as to which strategies of the multi-component interventions are most potent and which may be unnecessary. This uncertainty reduces reproducibility and limits large-scale implementation.
The goal of this study is to identify mechanisms of action that reliably enhance participation in role-relevant activities after breast cancer treatment. The Multiphase Optimization STrategy (MOST) framework of intervention development uses engineering principles to build multi-component interventions that are both potent (i.e., produce clinically relevant outcomes) and parsimonious (i.e., contain no inactive ingredients). The first phase of MOST creates a conceptual model linking intervention components (i.e., strategies) and the intended targets and identifies an optimization criterion by which success will be judged. This study's optimization criterion is to find the combination of intervention components that has the largest effect on participation restrictions. This proposal reflects the second phase of MOST, the optimization phase, where the investigators will evaluate the degree to which each intervention component exerts an independent or synergistic effect on participation restrictions. The optimization phase ensures that the resulting intervention is composed only of components that are contributing to the outcome of interest.
This study will use a factorial experiment to test three intervention components that have been used with breast cancer survivors: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning. The components each have a modest evidence base supporting their efficacy to reduce participation restrictions. However, they have different profiles regarding a) the time survivors need to invest and b) the skills practitioners need to successfully deliver. To move the science forward, it is crucial to develop a potent yet parsimonious intervention with empirically-supported mechanisms of action.
This study's research question is: Which components alone or in combination have the greatest impact on participation restrictions? Using the MOST framework, the investigators will conduct an optimization trial with a factorial design. The investigators will recruit 352 breast cancer survivors reporting participation restrictions in the first year following curative treatment; participants will be randomized to receive combinations of the 3 components.
Aim 1: To identify the intervention components that reduce participation restrictions (primary outcome). Intervention components: a) priority elicitation (priority-elicitation coaching versus following a static menu of goals and topics); b) cancer survivorship education (therapist-administered versus weblink); and c) guided application (included versus not). Criterion: A component will be considered effective if its presence produces a main or interaction effect of Cohen's d of > 0.30.
Aim 2: To test the conceptual model by determining the degree to which each intervention component affects the following proximal targets: H1: Priority elicitation will have the strongest effect on engagement in valued activities. H2: Cancer survivorship education will have the strongest effect on self-efficacy for managing health. H3: Guided application will have the strongest effect on adaptive coping.
Aim 3: To assemble an intervention package by evaluating the main effects and interactions with the following optimization criterion: The largest effect on participation restrictions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Randomized 2X3 factorial experiment reflecting the optimization phase of the Multiphase Optimization Strategy (MOST) Framework
| Arm | Type | Receives |
|---|---|---|
| Priority elicitation, education, and guided application | Experimental | Behavioral: Individually tailored education and guided application to promote activity participationWeekly telephone or videoconference sessions with a coach where participants will discuss survivorship information and set goals and action plans that are tailored to personal priorities |
| Priority elicitation and guided application | Experimental | Behavioral: Individually tailored guided applicationWeekly telephone or videoconference sessions with a coach where participants will set goals and action plans that are tailored to personal priorities; survivorship information tailored to personal priorities will be emailed to participants |
| Priority elicitation and education | Experimental | Behavioral: Individually tailored educationWeekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities |
| Priority elicitation | Experimental | Behavioral: Priority elicitationTelephone or videoconference sessions with a coach in the first and last week where participants will discuss personal priorities for recovery; survivorship information tailored to personal priorities will be emailed to participants each week |
| Education and guided application | Experimental | Behavioral: Static education and guided applicationWeekly telephone or videoconference sessions with a coach where participants will discuss survivorship information and set goals and action plans from a static menu of six different topics |
| Guided application | Experimental | Behavioral: Static guided applicationWeekly telephone or videoconference sessions with a coach where participants will set goals and action plans from a static menu of six different topics; survivorship information from a static menu of six different topics will be emailed to participants each week |
| Education | Experimental | Behavioral: Static educationWeekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics |
| Information | Experimental | Behavioral: InformationWeekly survivorship education will be emailed to participants, from a static menu of six different topics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older,
- Diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or adjuvant therapy with curative intent and absence of disease recurrence,
- Experiencing reduced participation (i.e., a score of > 10 on the Work and Social Adjustment Scale).
Key exclusion criteria (4 listed)
- Non-English speaking.
- Non-correctable hearing loss.
- Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
- History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.
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 |
|---|---|---|
| Individually tailored education and guided application to promote activity participationThis condition has high levels of the three components: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning. | Behavioural | Priority elicitation, education, and guided application |
| Individually tailored guided applicationThis condition contains high levels of priority elicitation and guided application. | Behavioural | Priority elicitation and guided application |
| Individually tailored educationThis condition contains how levels of the components of priority elicitation and education | Behavioural | Priority elicitation and education |
| Priority elicitationThis condition contains the high level of the priority elicitation component | Behavioural | Priority elicitation |
| Static education and guided applicationThis condition has high levels of the education and guided application components | Behavioural | Education and guided application |
| Static guided applicationThis condition contains high level of the guided application component | Behavioural | Guided application |
| Static educationThis condition contains the high level of the education component | Behavioural | Education |
| InformationThis condition contains the low levels of the three components | Behavioural | Information |
Primary outcome
Participation satisfaction: PROMIS Satisfaction with Social Roles and Activities Short Form 8a
Time frame: Baseline to week 20
Scores range from 8 to 40, with higher values representing greater satisfaction with ability to participate in social roles and activities.
4 secondary outcomes
Participation ability: Ability to Participate in Social Roles and Activities Short Form 8a
Time frame: Baseline to 20 weeks
Valuing Questionnaire: Engagement in valued activities
Time frame: Baseline to 20 weeks
Self-efficacy for health management: Self-Efficacy for Managing Chronic Disease Scale
Time frame: Baseline to 20 weeks
Adaptive coping: Brief COPE subscales
Time frame: Baseline to 20 weeks
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 25 Mar 2026.
- Individual participant dataSharing planned: Yes. This study is expected to generate qualitative and quantitative data from up to 352 people who have finished treatment for Stage 1-3 breast cancer within the past year). Qualitative data include answers to open-ended questions about the acceptability and utility of the intervention components. Qualitative data also include the treatment session documentation (e.g., topics of goals set, education delivered). Quantitative data include participant characteristics (e.g., age, gender, type of treatment, marital status) and answers to the survey outcome assessments of participation restrictions, adaptive coping, meaningful activity engagement, and self-efficacy. All raw and scored quantitative data will be de-identified, preserved, and made publicly available for at least 7 years post-publication of findings. The qualitative data (which is harder to de-identify and may contain sensitive information that the disclosure of which could negatively affect participants) will not be shared.
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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 D Lyons, ScD 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 Individually tailored education and guided application to promote activity participation, Individually tailored guided application and Individually tailored education in people with Breast Neoplasms, 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Mar 2026. 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 Kathleen D Lyons, ScD (617-643-5372, KLyons2@mghihp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation satisfaction: PROMIS Satisfaction with Social Roles and Activities Short Form 8a (time frame: Baseline to week 20). 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 25 Mar 2026.