Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners (PCDM)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Dr. Allison Magnuson Principal Investigator
- Phone Number: (585) 275-5823
- Email: Allison_magnuson@urmc.rochester.edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14620
- University of Rochester
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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)
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)
|
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)
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)
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
The PAM 13 (originally developed as a 22-item measure and later modified to 13 items) is a valid and reliable tool to measure stages of activation, including belief that the patient role is important and having the confidence and knowledge to take action.
The PAM-13 is scored 0-100, with higher scores indicating greater patient activation.
|
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)
|
The DSE scale measures self-confidence and belief in one's abilities in decision-making.
The 11-item questionnaire assesses confidence in aspects such as ability to get the facts about treatment options available, including choices and benefits and side effects of choices, and ability to understand the information and ask questions/express concerns.
Scoring is converted to a 0-100 scale, with higher scores indicating greater self-efficacy in decision-making.
Prior studies suggest that scores below 70 were observed in patients who were significantly less likely to engage in shared decision-making and more likely to report decision regret later.43-45
This measure has been utilized in other studies of patients with advanced cancer.
|
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)
|
The SDM-Q-9 measures the extent to which patients are involved in the process of decision-making from the perspective of the patient.
The instrument has 9 questions and is a reliable and well accepted, with high internal consistency and discriminative validity.
The measure is scored on a scale of 0-100 and can be used to assess longitudinal change in shared decision making in clinical settings with an MCID of 4 points used in prior studies.
|
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)
|
Caregiver Activation Measure: A measure that was developed and validated to assess care partner's' knowledge, skill, and confidence for self-management of a chronic medical condition.
Greater degrees of activation (e.g., higher degree of knowledge, skill, and confidence) can facilitate the shared decision-making process.
|
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)
|
The HCCQ is a measure of satisfaction with communication that evaluates patients and care partners perceptions of autonomy support and shared decision making and evaluates whether they feel their oncology clinician(s) understand their perspective, provides choices, and encourage participation in decisions.
The HCCQ measure has been validated in older adult populations.
The full HCCQ scale has a reliability of >0.9.
The six-item version will be utilized, which has demonstrated excellent internal consistency and construct validity in the oncology setting.
|
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)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UOCPC25063
- STUDY00010968 (Other Identifier: University of Rochester)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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