Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07489053 for Breast Neoplasms is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Optimizing Functional Recovery After Breast Cancer Treatment 352
Clinical Trial NCT07489053 is an interventional study for Breast Neoplasms and is currently not yet recruiting. Enrollment is planned to begin on 1 January 2027 and continue until the study accrues 352 participants. Led by MGH Institute of Health Professions, this study is expected to complete by 30 September 2030. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief 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.
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 instrum...
Show MoreDetailed 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 cos...Show More
Official Title
Optimization of a Multicomponent Intervention to Foster Functional Recovery After Breast Cancer Treatment
Conditions
Breast NeoplasmsOther Study IDs
- 2026P000285
NCT ID Number
Start Date (Actual)
2027-01-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-09-30
Enrollment (Estimated)
352
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
randomized controlled trial
factorial experiment
rehabilitation
factorial experiment
rehabilitation
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Factorial
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPriority elicitation, education, and guided application 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 | 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. |
ExperimentalPriority 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 | Individually tailored guided application This condition contains high levels of priority elicitation and guided application. |
ExperimentalPriority elicitation and education Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities | Individually tailored education This condition contains how levels of the components of priority elicitation and education |
ExperimentalPriority 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 | Priority elicitation This condition contains the high level of the priority elicitation component |
ExperimentalEducation 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 | Static education and guided application This condition has high levels of the education and guided application components |
ExperimentalGuided 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 | Static guided application This condition contains high level of the guided application component |
ExperimentalEducation Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics | Static education This condition contains the high level of the education component |
ExperimentalInformation Weekly survivorship education will be emailed to participants, from a static menu of six different topics | Information This condition contains the low levels of the three components |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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. | 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 | 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. | Baseline to 20 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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).
- 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.
MGH Institute of Health ProfessionsStudy Responsible Party
Kathleen Lyons, ScD, OTR/L, Principal Investigator, Professor, MGH Institute of Health Professions
Study Central Contact
Contact: Kathleen D Lyons, ScD, 617-643-5372, [email protected]
Contact: Sheel Singh, MA, 617-724-9835, [email protected]
1 Study Locations in 1 Countries
Massachusetts
MGH Institute of Health Professions, Boston, Massachusetts, 02129, United States
Sheel Singh, MA, Contact, 617-724-9835, [email protected]
Kathleen Lyons, ScD, Contact, 617-643-5372, [email protected]
Kathleen Lyons, ScD, Principal Investigator