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

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NCT03375827

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Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
Official Title  ICMJE Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: IGCDG
The IGCDG reviews topics of concern for patients with metastatic breast cancer.
Study Arms  ICMJE Experimental: Survey QOL
  • 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.
Intervention: Other: IGCDG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 21, 2018)		45
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)		40
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03375827
Other Study ID Numbers  ICMJE 17-398
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Jeffrey Peppercorn, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jeffrey Peppercorn, MDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP