SHARE (Sharing Goals and Preferences) Study

Other Cancer Clinical Trial

Official title:

SHARE (Sharing Goals and Preferences) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392090
• Other study ID #: 17-520
• Status: Completed
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 15, 2022
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana Farber Cancer Institute at St Elizabeth	Boston	Massachusetts
United States	Nancy Keating	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Cancer Society, Inc., Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	% of patients invited to participate who choose to enroll	2 years
Primary	Overall rating of intervention	% who rate intervention as good/very good/excellent.	1 month
Primary	Would recommend intervention to others	% who would recommend intervention to others with cancers like theirs	1 month
Secondary	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
Secondary	Patient anxiety	Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)	1 month
Secondary	Patient distress	National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)	1 month
Secondary	Patient depression	Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)	1 month
Secondary	Hope	Hearth Hope Index (12 items, score 12 to 48, higher = more hope)	1 month
Secondary	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
Secondary	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
Secondary	Therapeutic Alliance	Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)	1 month