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SHARE (Sharing Goals and Preferences) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392090
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
American Cancer Society, Inc.
Harvard Medical School (HMS and HSDM)
Information provided by (Responsible Party):
Nancy L. Keating, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
This research study is evaluating the usefulness of a video and questionnaire to help cancer patients think about the goals of their care.

Condition or disease Intervention/treatment Phase
Other Cancer Other: More Good Days video&brief questionnaire Not Applicable

Detailed Description:

The investigators are conducting a study with patients from Dana Farber Cancer Institute (DFCI) and DFCI-affiliate at St. Elizabeth's Hospital who are being treated for their cancer. The purpose of the study is to test the implementation of a short video, a brief questionnaire, and a wallet card designed to help patients understand and articulate their goals and preferences when making decisions about their cancer treatment and communicate these preferences to their clinicians.

The short video and brief questionnaire were developed to help patients with cancer think about their goals of care and their treatment and information preferences and to prompt discussions with their health care team about these preferences. The wallet card is designed to help patients remember some key questions that may be useful as they make decisions about future treatments

A pilot test will be completed to assess the feasibility and usability of the revised "More Good Days" video, brief questionnaire and wallet card in helping seriously-ill cancer patients think about what a good day means to them and test whether these tools can help patients to identify and communicate their medical treatment preferences and goals with their care team.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: SHARE (Sharing Goals and Preferences) Study
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : October 18, 2019
Estimated Study Completion Date : January 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: More Good Days video&brief questionnaire
  • Participants will watch the More Good Days video and will be given a brief questionnaire and wallet card to help identify their goals and preferences about information and care
  • The More Good Days video is developed to help patients with advanced cancer think about what a good day means to them and to help them think about questions they may have for their physicians when discussing treatments.
  • The 3-page brief questionnaire is designed to help patients identify their preferences about information and care and to help encourage a conversation between patients and their doctors and health care team about their goals and preferences
  • The wallet card will help patients think about questions they may want to ask their providers when considering treatments.
 Other: More Good Days video&brief questionnaire
Help patients with advanced cancer think about what a good day means to them and to help them think about questions they may have for their physicians when discussing treatments


Outcome Measures
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Primary Outcome Measures :
  1. Enrollment [ Time Frame: 2 years ]
    % of patients invited to participate who choose to enroll

  2. Overall rating of intervention [ Time Frame: 1 month ]
    % who rate intervention as good/very good/excellent.

  3. Would recommend intervention to others [ Time Frame: 1 month ]
    % who would recommend intervention to others with cancers like theirs


Secondary Outcome Measures :
  1. Preferred format for viewing video and completing questionnaire [ Time Frame: 1 month ]
    preferences for watching alone vs. with family; in clinic vs. home, interest in accessing via electronic record portal

  2. Patient anxiety [ Time Frame: 1 month ]
    Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)

  3. Patient distress [ Time Frame: 1 month ]
    National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)

  4. Patient depression [ Time Frame: 1 month ]
    Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)

  5. Hope [ Time Frame: 1 month ]
    Hearth Hope Index (12 items, score 12 to 48, higher = more hope)

  6. FACIT-PAL Quality of Life [ Time Frame: 1 month ]
    FACIT-PAL instrument general quality of life (27 general items, score 0 to 108, higher=better quality of life)

  7. Quality of life-palliative care specific items [ Time Frame: 1 month ]
    Palliative care subscale of FACITPAL (14 items, score 0 to 56, higher = better quality of life)

  8. Therapeutic Alliance [ Time Frame: 1 month ]
    Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)


Eligibility Criteria
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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:

  • Patient who are receiving treatment at:

    • DFCI in the thoracic oncology group
    • DFCI-affiliated St. Elizabeth's Hospital and have progressed on 2nd line or later-line systemic therapies (chemotherapy, immunotherapy, biological, or targeted therapies)
  • Clinicians' schedules to identify patients with metastatic cancers who are considering or pursuing additional palliative therapy

Exclusion Criteria:

  • Patients who are not interested in the study
  • Patients of physicians who opt out of participating
  • Patients whose physicians did not opt out, but whose physician does not think they are well suited for the study
Contacts and Locations
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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): NCT03392090


Locations
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United States, Massachusetts
Dana Farber Cancer Institute at St Elizabeth
Boston, Massachusetts, United States, 02062
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Harvard Medical School
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
American Cancer Society, Inc.
Harvard Medical School (HMS and HSDM)
Investigators
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Principal Investigator: Nancy L Keating, MD Harvard Medical School (HMS and HSDM)
More Information
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Responsible Party: Nancy L. Keating, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03392090    
Other Study ID Numbers: 17-520
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
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 Nancy L. Keating, Dana-Farber Cancer Institute:
Cancer