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History of Changes for Study: NCT04149704
Videos for Advance Care Planning in Young Adults
Latest version (submitted May 31, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 31, 2019 None (earliest Version on record)
2 February 5, 2020 Recruitment Status, Study Status and Contacts/Locations
3 February 10, 2021 Study Status
4 September 13, 2021 Study Status and Eligibility
5 January 10, 2022 Study Status
6 February 22, 2022 Study Status and Outcome Measures
7 May 31, 2022 Recruitment Status, Study Status and Study Design
Comparison Format:

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Study NCT04149704
Submitted Date:  October 31, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-409
Brief Title: Videos for Advance Care Planning in Young Adults
Official Title: Videos for Advance Care Planning in Young Adults
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2019
Overall Status: Not yet recruiting
Study Start: November 2019
Primary Completion: August 1, 2021 [Anticipated]
Study Completion: August 1, 2022 [Anticipated]
First Submitted: October 31, 2019
First Submitted that
Met QC Criteria:
October 31, 2019
First Posted: November 4, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
October 31, 2019
Last Update Posted: November 4, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Dana-Farber Cancer Institute
Responsible Party: Principal Investigator
Investigator: Jennifer Snaman, MD, MS
Official Title: Principal Investigator
Affiliation: Dana-Farber Cancer Institute
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

This study is a randomized trial of adolescent and young adults with advanced cancer and their caregivers to assess preferences for care in advanced cancer. This research study is examining the similarities and differences between patient's and caregiver's goals of cancer care.

The names of the study interventions involved in this study may include:

  • Questionnaires
  • Video
  • Phone Interview
Detailed Description:

The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.

- Patients and their caregivers will be randomized into the same group; either ACP video decision aid intervention or usual care.

  • Patients' and caregivers' knowledge, preferences (goals of care, CPR, ventilation), and decisional conflict be assessed before and after the ACP video decision aid intervention or usual care.
  • Participants will be in this research study for up to 3 months with only 2 study visits.
  • It is expected that about 100 people (50 patients and 50 caregivers) will take part in this research study.
Open or close this module Conditions
Conditions: Advanced Cancer
Keywords: Advanced Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Health Services Research
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ACP video decision aid

The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.

  • In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
  • 10 minute video decision aid: describing the goals-of-care options .
  • Follow telephone interview at 3 months
Behavioral: ACP video decision aid
10 minute video decision aid describing the goals-of-care options
Active Comparator: Standard Care

The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.

  • In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
  • Receive the verbal description of the three types of care
  • Follow telephone interview at 3 months
Usual Care-
Verbal description of the three types of care
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Increased Concordance Rate
[ Time Frame: 3 Months ]

AYA with advanced cancer and caregivers randomized to the video will have higher concordance between patients and caregivers
Secondary Outcome Measures:
1. Increased Advance Care Planning (ACP) Conversations
[ Time Frame: baseline and 3 months ]

Patients randomized to the video will have more ACP conversations and documentation after 3 months.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Subject Enrollment: All patients will be recruited from the outpatient clinics of Dana-Farber Cancer Institute (both pediatric and adult clinics) and the inpatient settings of Boston Children's Hospital and Brigham and Women's Hospital. Eligible study participants will give written consent to the primary investigator or study staff member before initiation of study procedures.
  • Patient Eligibility criteria will include patients who are:
    • Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, and cure is unlikely) and are eligible for, previously been treated on, or have agreed to participate in a Phase I/II trial;
    • Aged between 18-24, which is the legal age for completing an ACP document (e.g., POLST/MOLST);
    • Speak English; and
    • Have a caregiver or identified surrogate decision maker who is able to participate.
  • Exclusion criteria will include:
    • Visually impaired (note, hearing impaired is not an exclusion as the video is closed captioned)
    • Psychological state not appropriate for ACP discussions as determined by the primary oncologist
    • Unable to participate in ACP discussions due to mental incapacity as determined by the Short Portable Mental Status Questionnaire
  • Over 95% of patients with advanced cancer in the Dana-Farber inpatient setting are accompanied by a caregiver (i.e., family member, spouse or friend; this person is not necessarily the designated surrogate decision-maker since most AYA have not appointed one).
  • Eligible patient participants will be asked to self-identify one caregiver or surrogate decision-maker that will also be approached for enrollment.

Caregiver eligibility criteria include:

  • Speak English;
  • Aged 18 or older
  • Not visually impaired
  • Have an associated patient with advancer cancer who is able to participate.
  • Only dyads will be enrolled, both patient and caregiver must consent to participation in the study.
Open or close this module Contacts/Locations
Central Contact Person: Jennifer Snaman, MD, MS
Telephone: 617-632-5548
Email: Jennifer_snaman@dfci.harvard.edu
Study Officials: Jennifer Snaman, MD, MS
Principal Investigator
Dana-Farber Cancer Institute
Locations: United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Contact:Contact: Jennifer Snaman, MD, MS 617-632-5548 Jennifer_snaman@dfci.harvard.edu
Contact:Principal Investigator: Jennifer Snaman, MD, MS
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Contact:Contact: Jennifer Snaman, MD, MS 617-632-5548 Jennifer_snaman@dfci.harvard.edu
Contact:Sub-Investigator: Jennifer Snaman, MD, MS
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Contact:Contact: Jennifer Snaman, MD, MS 617-632-5548 Jennifer_snaman@dfci.harvard.edu
Contact:Principal Investigator: Jennifer Snaman, MD, MS
Open or close this module IPDSharing
Plan to Share IPD: Yes
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame:
Data can be shared no earlier than 1 year following the date of publication
Access Criteria:
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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