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Not yet recruiting NCT07599618

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

No phase Interventional Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision-making support tool.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

The primary objective (Aim 1) of this study will be to evaluate feasibility of utilizing the patient-centered decision-making (PCDM) tool for older adults with metastatic breast cancer (mBC). The PCDM tool has been developed by the investigators in collaboration with Manta Cares, Inc. During the development process, we have integrated Geriatric Assessment (GA), completed fully by patients, into the PCDM tool, along with potential supportive care strategies (e.g., recommendations) that could be considered by patients and their care partners if areas of impairment are noted on the GA embedded into the PDCM tool. Feasibility of the adapted PCDM tool will be assessed both quantitatively and qualitatively, and through mixed methods (integrating quantitative and qualitative data) to provide a deeper understanding of aspects of implementation across settings.

Interventions

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

Primary outcome measures

  • Patient and care partner Acceptability of Intervention (AIM) [Time frame: 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) [Time frame: 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) [Time frame: 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 outcome measures (5)
  • Patient Activation Measure-13 (PAM-13) [Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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)]

Eligibility criteria

Inclusion criteria

Patient Inclusion Criteria:

  • 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

Care Partner Inclusion Criteria:

  • 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

Exclusion criteria

Patient Exclusion Criteria:

  • Early-stage breast cancer
  • Diagnosis of any other cancer besides metastatic breast cancer

Care Partner Exclusion Criteria:

1\. Verbal permission from patient to enroll care partner not received.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Rochester — Rochester

Identifiers

NCT: NCT07599618 · UOCPC25063 · STUDY00010968

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗