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Completed

NCT Number: NCT03392090

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

More Good Days video&brief questionnaire

Other

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

Primary outcomes

  1. Enrollment

    Time frame: 2 years

    % of patients invited to participate who choose to enroll

  2. Overall rating of intervention

    Time frame: 1 month

    % who rate intervention as good/very good/excellent.

  3. Would recommend intervention to others

    Time frame: 1 month

    % who would recommend intervention to others with cancers like theirs

Secondary outcomes

  1. Preferred format for viewing video and completing questionnaire

    Time frame: 1 month

    preferences for watching alone vs. with family; in clinic vs. home, interest in accessing via electronic record portal

  2. Patient anxiety

    Time frame: 1 month

    Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)

  3. Patient distress

    Time frame: 1 month

    National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)

  4. Patient depression

    Time frame: 1 month

    Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)

  5. Hope

    Time frame: 1 month

    Hearth Hope Index (12 items, score 12 to 48, higher = more hope)

  6. FACIT-PAL Quality of Life

    Time frame: 1 month

    FACIT-PAL instrument general quality of life (27 general items, score 0 to 108, higher=better quality of life)

  7. Quality of life-palliative care specific items

    Time frame: 1 month

    Palliative care subscale of FACITPAL (14 items, score 0 to 56, higher = better quality of life)

  8. Therapeutic Alliance

    Time frame: 1 month

    Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • American Cancer Society, Inc.
  • Harvard Medical School (HMS and HSDM)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Jan 5, 2018
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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