[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630544":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":87,"overallOfficials":119,"centralContacts":123,"locations":132,"responsibleParty":152,"collaborators":155,"id":162,"slug":37,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":37,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":37,"enrollmentInfo":170,"targetDuration":37,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":183,"whyStopped":37,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"MGH Institute of Health Professions","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline to week 20",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"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","Baseline to 20 weeks",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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",{"measure":25,"description":26,"timeFrame":17},"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.",[28],{"measure":29,"description":30,"timeFrame":31},"Acceptability of intervention components","Open-ended questions regarding acceptability and utility of components received","8 weeks post-baseline",{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":37,"timePerspective":37,"maskingInfo":38},"RANDOMIZED","FACTORIAL","Randomized 2X3 factorial experiment reflecting the optimization phase of the Multiphase Optimization Strategy (MOST) Framework","SUPPORTIVE_CARE",null,{"masking":39,"maskingDescription":40,"whoMasked":41},"DOUBLE","Data collectors and principal investigator will be blind to participant condition; participants will be instructed not to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the coach involved in delivering the intervention.",[42,43],"INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nMost 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.\n\nThe 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.\n\nThis 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.\n\nThis 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.\n\nAim 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.\n\nAim 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.\n\nAim 3: To assemble an intervention package by evaluating the main effects and interactions with the following optimization criterion: The largest effect on participation restrictions.",[46,52,57,62,67,72,77,82],{"label":47,"type":48,"description":49,"interventionNames":50},"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",[51],"Behavioral: Individually tailored education and guided application to promote activity participation",{"label":53,"type":48,"description":54,"interventionNames":55},"Priority elicitation and guided application","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",[56],"Behavioral: Individually tailored guided application",{"label":58,"type":48,"description":59,"interventionNames":60},"Priority elicitation and education","Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities",[61],"Behavioral: Individually tailored education",{"label":63,"type":48,"description":64,"interventionNames":65},"Priority elicitation","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",[66],"Behavioral: Priority elicitation",{"label":68,"type":48,"description":69,"interventionNames":70},"Education and guided application","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",[71],"Behavioral: Static education and guided application",{"label":73,"type":48,"description":74,"interventionNames":75},"Guided application","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",[76],"Behavioral: Static guided application",{"label":78,"type":48,"description":79,"interventionNames":80},"Education","Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics",[81],"Behavioral: Static education",{"label":83,"type":48,"description":84,"interventionNames":85},"Information","Weekly survivorship education will be emailed to participants, from a static menu of six different topics",[86],"Behavioral: Information",[88,93,97,101,104,108,112,116],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":37},"BEHAVIORAL","Individually tailored education and guided application to promote activity participation","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.",[47],{"type":89,"name":94,"description":95,"armGroupLabels":96,"otherNames":37},"Individually tailored guided application","This condition contains high levels of priority elicitation and guided application.",[53],{"type":89,"name":98,"description":99,"armGroupLabels":100,"otherNames":37},"Individually tailored education","This condition contains how levels of the components of priority elicitation and education",[58],{"type":89,"name":63,"description":102,"armGroupLabels":103,"otherNames":37},"This condition contains the high level of the priority elicitation component",[63],{"type":89,"name":105,"description":106,"armGroupLabels":107,"otherNames":37},"Static education and guided application","This condition has high levels of the education and guided application components",[68],{"type":89,"name":109,"description":110,"armGroupLabels":111,"otherNames":37},"Static guided application","This condition contains high level of the guided application component",[73],{"type":89,"name":113,"description":114,"armGroupLabels":115,"otherNames":37},"Static education","This condition contains the high level of the education component",[78],{"type":89,"name":83,"description":117,"armGroupLabels":118,"otherNames":37},"This condition contains the low levels of the three components",[83],[120],{"name":121,"affiliation":5,"role":122},"Kathleen D Lyons, ScD","PRINCIPAL_INVESTIGATOR",[124,128],{"name":121,"role":125,"phone":126,"phoneExt":37,"email":127},"CONTACT","617-643-5372","KLyons2@mghihp.edu",{"name":129,"role":125,"phone":130,"phoneExt":37,"email":131},"Sheel Singh, MA","617-724-9835‬‬‬‬‬‬‬‬‬","ssingh@mghihp.edu",[133],{"facility":5,"status":37,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"Boston","Massachusetts","02129","United States","US",{"type":140,"coordinates":141},"Point",[142,143],-71.05977,42.35843,{"lat":143,"lon":142},[146,148,151],{"name":129,"role":125,"phone":147,"phoneExt":37,"email":131},"617-724-9835",{"name":149,"role":125,"phone":126,"phoneExt":37,"email":150},"Kathleen Lyons, ScD","carelab@partners.org",{"name":149,"role":122,"phone":37,"phoneExt":37,"email":37},{"type":122,"investigatorFullName":153,"investigatorTitle":154,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Kathleen Lyons, ScD, OTR\u002FL","Professor",[156,158,160],{"name":157,"class":6},"University of Alabama at Birmingham",{"name":159,"class":6},"University of South Alabama",{"name":161,"class":6},"Dartmouth-Hitchcock Medical Center","100630544",false,"NCT07489053","Optimizing Functional Recovery After Breast Cancer Treatment","Optimization of a Multicomponent Intervention to Foster Functional Recovery After Breast Cancer Treatment","Inclusion Criteria:\n\n1. Age of 18 years or older,\n2. Diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and\u002For adjuvant therapy with curative intent and absence of disease recurrence,\n3. Experiencing reduced participation (i.e., a score of \\> 10 on the Work and Social Adjustment Scale).\n\nExclusion Criteria:\n\n1. Non-English speaking.\n2. Non-correctable hearing loss.\n3. Moderate-severe cognitive impairment indicated by a score \\\u003C 3 on a 6-item cognitive screener.\n4. 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.","ALL","18 Years",{"count":171,"type":172},352,"ESTIMATED","INTERVENTIONAL",[175],"NA","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.\n\nThe 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?\n\nParticipants 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.",[178],"Breast Neoplasms",[180,181,182],"randomized controlled trial","factorial experiment","rehabilitation","NOT_YET_RECRUITING","2026-03-21",{"date":186,"type":187},"2026-03-25","ACTUAL",{"date":189,"type":172},"2027-01-01",{"date":191,"type":172},"2030-09-30",{"name":5,"class":6},1]