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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 : Unknown
Verified December 2018 by Jeffrey Peppercorn, Massachusetts General Hospital.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date December 24, 2018
Actual Study Start Date  ICMJE January 22, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MD Massachusetts 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