Clinical trial · Interventional
Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners
NCT07599618CI-TRIAL-00112510PCDMnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision-making support tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Patient and care partner Acceptability of Intervention (AIM)
- timeFrame
- Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
- description
- Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
- measure
- Intervention Appropriateness Measure (IAM)
- timeFrame
- Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
- description
- Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Patient Inclusion Criteria: 1. A diagnosis of metastatic breast cancer 2. Age 65 or older 3. Currently receiving systemic treatment for metastatic breast cancer or considering a plan to initiate systemic treatment for metastatic breast cancer 4. Able to speak and read English (because the Manta Cares platform is presently only offered in English only) 5. Able to provide informed consent Care Partner Inclusion Criteria: 1. Age 18 or older 2. Able to speak and read English (because the Manta Cares platform is presently only offered in English only) 3. Able to provide informed consent 4. Verbal permission from patient to enroll their designated care partner Exclusion Criteria: Patient Exclusion Criteria: 1. Early-stage breast cancer 2. Diagnosis of any other cancer besides metastatic breast cancer Care Partner Exclusion Criteria: 1\. Verbal permission from patient to enroll care partner not received.
References
Publications (0)
Data not yet available
No reference posted for this study.