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

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ClinicalTrials.gov Identifier: NCT03375827
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jeffrey Peppercorn, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: IGCDG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Other: IGCDG
The IGCDG reviews topics of concern for patients with metastatic breast cancer.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 2 years ]
    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. Attrition rate [ Time Frame: 2 years ]
    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.

  3. Change in distress [ Time Frame: 8 weeks after the IGCDG was provided to participant's clinician ]
    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.


Secondary Outcome Measures :
  1. Evaluate baseline preferences for care among patients with metastatic breast cancer via the Individualized Goals of Care Discussion Guide (IGCDG) questionnaire [ Time Frame: baseline ]
    The IGCDG questionnaire reviews topics of concern for patients with metastatic breast cancer, such as goals of cancer treatment and priorities for discussions with the patient's clinician. This is a descriptive, study specific measure.

  2. The Satisfaction with Decision Making Scale [ Time Frame: 8 weeks after the IGCDG was provided to participant's clinician ]
    This is a six item validated scale designed to measure patient satisfaction with medical decision making. Participants rate their level of agreement on a 5-point scale with statements regarding medical decision-making. (1 = strongly agree; 5 = strongly disagree) . Lower scores indicate higher inclusion of the patient in decision‐making.

  3. The Decisional Conflict Scale [ Time Frame: 8 weeks after the IGCDG was provided to participant's clinician ]
    This is a 16-item Likert scale with proven validity and reliability. Scores range from 1 to 5, with higher scores suggesting increased difficulty and conflict over decision making.

  4. Modified Control Preferences Scale [ Time Frame: 8 weeks after the IGCDG was provided to participant's clinician ]
    This 2 question scale is used to measure a participant's desired and actual participation in decision-making. As in prior work, the investigators have collapsed responses into 3 choices: decisions are made mainly by the patient, decisions are made equally, and decisions are made mainly by the clinician. Analysis is based on comparison of the participants reported desired role in decision making and actual role, with greater concordance indicating decision making that is aligned with the participants preferences.

  5. Patient Satisfaction with Cancer Care [ Time Frame: 8 weeks after the IGCDG was provided to participant's clinician ]
    The Patient Satisfaction with Cancer Care measure is a validated 18 item tool with responses on a 5 point Likert scale designed specifically to assess satisfaction among patients from diverse socio-demographic backgrounds. The investigators have modified the scale to remove 3 questions that were not relevant for this study population. Total score for this scale is calculated by adding all component scores, with lower scores indicating higher satisfaction with care.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375827


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
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Principal Investigator: Jeffrey Peppercorn, MD Massachusetts General Hospital

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Responsible Party: Jeffrey Peppercorn, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03375827     History of Changes
Other Study ID Numbers: 17-398
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Peppercorn, Massachusetts General Hospital:
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases