SHARE (Sharing Goals and Preferences) Study

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

Study Overview

• Status: Completed
• Conditions: Other Cancer
• Intervention / Treatment: Other: More Good Days video&brief questionnaire

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02062
      • Dana Farber Cancer Institute at St Elizabeth
    • Boston, Massachusetts, United States, 02115
      • Nancy Keating

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	% of patients invited to participate who choose to enroll	2 years
Overall rating of intervention	% who rate intervention as good/very good/excellent.	1 month
Would recommend intervention to others	% who would recommend intervention to others with cancers like theirs	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferred format for viewing video and completing questionnaire	preferences for watching alone vs. with family; in clinic vs. home, interest in accessing via electronic record portal	1 month
Patient anxiety	Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)	1 month
Patient distress	National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)	1 month
Patient depression	Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)	1 month
Hope	Hearth Hope Index (12 items, score 12 to 48, higher = more hope)	1 month
FACIT-PAL Quality of Life	FACIT-PAL instrument general quality of life (27 general items, score 0 to 108, higher=better quality of life)	1 month
Quality of life-palliative care specific items	Palliative care subscale of FACITPAL (14 items, score 0 to 56, higher = better quality of life)	1 month
Therapeutic Alliance	Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)	1 month

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Harvard Medical School (HMS and HSDM); American Cancer Society, Inc.
• Investigators: Principal Investigator: Nancy L Keating, MD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• Wright AA, Thompson E, Nguyen MV, Wescott P, Barry MJ, Lathan CS, Keating NL. The SHARE Study: Pilot Study of a Communication Intervention Designed to Elicit Advanced-Stage Cancer Patients' Preferences and Goals. J Palliat Med. 2022 Nov;25(11):1646-1654. doi: 10.1089/jpm.2021.0655. Epub 2022 Jun 23.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: 17-520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No