Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners

NCT07599618 | Not Yet Recruiting DMC

• 2 other identifiers: UOCPC25063STUDY00010968
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Patient and care partner Acceptability of Intervention (AIM)

  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.

  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)

• Intervention Appropriateness Measure (IAM)

  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.

  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)

• Feasibility of Intervention (FIM)

  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.

  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)

Secondary Outcomes (5)

• Patient Activation Measure-13 (PAM-13)

  Time Point 1: (within 2 months of informed consent) 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)

• Decision Self-Efficacy Scale (DSE)

  Time Point 1: (within 2 months of informed consent) 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)

• Shared Decision-Making Questionnaire (SDM-Q-9)

  Time Point 1: (within 2 months of informed consent) 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)

• Caregiver Activation Measure (CG-PAM)

  Time Point 1: (within 2 months of informed consent) 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)

• Heath Care Climate Questionnaire (HCCQ)

  Time Point 1: (within 2 months of informed consent) 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)

Interventions

Decision-making support tool OTHER

Determine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• A diagnosis of metastatic breast cancer
• Age 65 or older
• Currently receiving systemic treatment for metastatic breast cancer or considering a plan to initiate systemic treatment for metastatic breast cancer
• Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
• Able to provide informed consent
• Age 18 or older
• Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
• Able to provide informed consent
• Verbal permission from patient to enroll their designated care partner

You may not qualify if:

• Early-stage breast cancer
• Diagnosis of any other cancer besides metastatic breast cancer
• \. Verbal permission from patient to enroll care partner not received.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dr. Allison Magnuson Principal Investigator

CONTACT

(585) 275-5823; Allison_magnuson@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: To determine the feasibility for the PCDM tool for older adults with mBC and their care partners, we will conduct a single arm pilot study within the Wilmot Cancer Institute and affiliated satellite locations in the network. N=150 older adults (aged 65+) with mBC will be enrolled over a nine-month period; one care partner per patient may also elect to enroll with each patient, however patients can still participate without a care partner. Patients and care partners will be followed for a six-month period after enrollment.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)