About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Early-stage breast cancer
Diagnosis of any other cancer besides metastatic breast cancer
Trial design
Single group
Treatments tested in this trial
Decision-making support tool
Other interventionDetermine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
Patient Activation Measure-13 (PAM-13)
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.
Decision Self-Efficacy Scale (DSE)
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.
Shared Decision-Making Questionnaire (SDM-Q-9)
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.
Caregiver Activation Measure (CG-PAM)
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.
Sponsors and contacts
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