Metastatic Breast Cancer
Conditions
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.
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
OTHERDecision-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.
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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. All study participants (patients and their care partners) will get the same intervention of the PCDM tool.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and care partner Acceptability of Intervention (AIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
| Feasibility of Intervention (FIM) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 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. |
| 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) | 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) | 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. |
| 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) | 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. |
Countries
United States
Contacts
CONTACTDr. Allison Magnuson Principal Investigator
Outcome results
None listed