NCT03392090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

December 20, 2017

Last Update Submit

March 15, 2022

Conditions

Other Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Preferred format for viewing video and completing questionnaire

    1 month

  • Patient anxiety

    1 month

  • Patient distress

    1 month

  • Patient depression

    1 month

  • Hope

    1 month

  • +3 more secondary outcomes

Study Arms (1)

More Good Days video&brief questionnaire

EXPERIMENTAL

* 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

Interventions

More Good Days video&brief questionnaireOTHER

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

More Good Days video&brief questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana Farber Cancer Institute at St Elizabeth

Boston, Massachusetts, 02062, United States

Location

Nancy Keating

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 35736783DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nancy L Keating, MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 5, 2018

Study Start

July 23, 2018

Primary Completion

October 18, 2019

Study Completion

March 15, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)