Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer

NCT03375827 | Completed

• 1 other identifier: 17-398
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the recruitment rate. Recruitment will be calculated as the number of patients who choose to participate divided by the number approached to enroll. A recruitment rate of greater than 50% will be deemed feasible. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.

  2 years

• Attrition rate

  The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the attrition rate. Attrition will be calculated as the number of participants who to do not complete the follow-up survey divided by the number enrolled. An attrition rate of less than 32% will be deemed feasible. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.

  2 years

• Change in distress

  The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the change in distress as measured by the NCCN distress thermometer between baseline administration and the 8-week follow-up survey. Lack of detection of a significant increase between baseline and follow-up distress scores among the participants will be interpreted as supporting feasibility. A significant increase in distress will be defined as \>50% of participants having an increase in distress ≥3 between baseline and follow-up. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.

  8 weeks after the IGCDG was provided to participant's clinician

Secondary Outcomes (5)

• Evaluate baseline preferences for care among patients with metastatic breast cancer via the Individualized Goals of Care Discussion Guide (IGCDG) questionnaire

  baseline

• The Satisfaction with Decision Making Scale

  8 weeks after the IGCDG was provided to participant's clinician

• The Decisional Conflict Scale

  8 weeks after the IGCDG was provided to participant's clinician

• Modified Control Preferences Scale

  8 weeks after the IGCDG was provided to participant's clinician

• Patient Satisfaction with Cancer Care

  8 weeks after the IGCDG was provided to participant's clinician

Study Arms (1)

Survey QOL

EXPERIMENTAL

* Study participants will be provided with the Individualized Goals of Care Discussion Guide (IGCDG) consisting of a brief pamphlet and the IGCDG questionnaire. * Participants will be asked to complete the IGCDG questionnaire prior to their next visit. * Participants will also complete an 8-week follow-up survey after the clinic visit to evaluate the impact on patient satisfaction with care, communication, and care received.

Other: IGCDG

Interventions

IGCDG OTHER

The IGCDG reviews topics of concern for patients with metastatic breast cancer.

Survey QOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey Peppercorn, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 18, 2017
• Study Start: January 22, 2018
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)