Clinical trial NCT03375827: Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
Official title: Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2017-12-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research study is evaluating whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit helps improve communication and decision-making in breast cancer care.

Detailed description: The purpose of this study is to understand patient preferences for communication and decision-making for advanced breast cancer. The investigators want to better understand what topics the participant wants their doctors and nurses to address with the participant in clinic, and the investigators want to evaluate whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit is a good idea that helps to improve communication and decision-making in breast cancer care.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Diagnosed with stage IV breast cancer within the past 3 years
* Receiving care at the MGH Cancer Center
* Verbal and written fluency in English
* Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Is medically or otherwise unable to participate (as determined by a physician or study PI)
* Enrolled in hospice

Primary outcomes:
measure: Recruitment rate
timeFrame: 2 years
measure: Attrition rate
timeFrame: 2 years
measure: Change in distress
timeFrame: 8 weeks after the IGCDG was provided to participant's clinician
Secondary outcomes:
measure: Evaluate baseline preferences for care among patients with metastatic breast cancer via the Individualized Goals of Care Discussion Guide (IGCDG) questionnaire
timeFrame: baseline
measure: The Satisfaction with Decision Making Scale
timeFrame: 8 weeks after the IGCDG was provided to participant's clinician
measure: The Decisional Conflict Scale
timeFrame: 8 weeks after the IGCDG was provided to participant's clinician
measure: Modified Control Preferences Scale
timeFrame: 8 weeks after the IGCDG was provided to participant's clinician
measure: Patient Satisfaction with Cancer Care
timeFrame: 8 weeks after the IGCDG was provided to participant's clinician
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeffrey Peppercorn, MD
role: PRINCIPAL_INVESTIGATOR
References: