SHARE (Sharing Goals and Preferences) Study

Not Applicable

Completed

• Conditions: Other Cancer
• Interventions: Other: More Good Days video&brief questionnaire

• Registration Number: NCT03392090
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Study Start: 2018-07-23
• Primary Completion: 2019-10-18
• Status Verified: 2022-03
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
More Good Days video&brief questionnaire	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Nancy Keating; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute at St Elizabeth; 🇺🇸 Boston, Massachusetts, United States