Clinical trial NCT03392090: SHARE (Sharing Goals and Preferences) Study
Official title: SHARE (Sharing Goals and Preferences) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Cancer
Keywords: Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Harvard Medical School (HMS and HSDM)
First posted: 2018-01-05
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Enrollment
timeFrame: 2 years
measure: Overall rating of intervention
timeFrame: 1 month
measure: Would recommend intervention to others
timeFrame: 1 month
Secondary outcomes:
measure: Preferred format for viewing video and completing questionnaire
timeFrame: 1 month
measure: Patient anxiety
timeFrame: 1 month
measure: Patient distress
timeFrame: 1 month
measure: Patient depression
timeFrame: 1 month
measure: Hope
timeFrame: 1 month
measure: FACIT-PAL Quality of Life
timeFrame: 1 month
measure: Quality of life-palliative care specific items
timeFrame: 1 month
measure: Therapeutic Alliance
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute at St Elizabeth
state: Massachusetts
city: Boston
country: United States
facility: Nancy Keating
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Nancy L Keating, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.