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Videos for Advance Care Planning in Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149704
Recruitment Status : Completed
First Posted : November 4, 2019
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jennifer Snaman, MD, MS, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE October 31, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date June 1, 2022
Actual Study Start Date  ICMJE December 13, 2019
Actual Primary Completion Date May 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2022)
Increased Concordance Rate [ Time Frame: baseline, 3 months ]
AYA with advanced cancer and caregivers randomized to the video will have higher concordance between patients and caregivers
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2022)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Videos for Advance Care Planning in Young Adults
Official Title  ICMJE Videos for Advance Care Planning in Young Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Behavioral: ACP video decision aid
    10 minute video decision aid describing the goals-of-care options
  • Other: Usual Care-
    Verbal description of the three types of care
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: ACP video decision aid
  • 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
    Intervention: Other: Usual Care-
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 5, 2022
Actual Primary Completion Date May 5, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

All patients will be recruited from the outpatient clinics of Dana-Farber Cancer Institute (both pediatric and adult clinics),the inpatient settings of Boston Children's Hospital and Brigham and Women's Hospital, the inpatient or outpatient clinics of Massachusetts General Hospital, or virtually. Eligible study participants will give written consent to the primary investigator or study staff member before initiation of study procedures if recruited in-person. If participants are enrolled and complete study procedures virtually, they will provide verbal consent before initiating study procedures.

If in-person visits cannot be conducted, eligible participants will be still be mailed a pre-notice letter that offers the chance for participants to opt-out or opt-in via email or phone call. After one week, we will call participants we have not heard from and ask if they would consider participating.

Patient Eligibility criteria will include patients who are:

i) Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, marked by progression or relapsed disease) ii) Aged between 18-39, which is the legal age for completing an ACP document (e.g., POLST/MOLST); iii) Speak English; and iv) Have a caregiver or identified surrogate decision maker who is able to participate.

v) Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital

Exclusion criteria will include:

i) A diagnosis of low-grade glioma given the fact that progressive or relapsed low grade may not be clinically characterized as advanced disease and associated poor prognosis.

ii) Visually impaired (note, hearing impaired is not an exclusion as the video is closed captioned); iii) Psychological state not appropriate for ACP discussions as determined by the primary oncologist; and, iv) Unable to participate in ACP discussions due to mental incapacity as determined by the Short Portable Mental Status Questionnaire

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04149704
Other Study ID Numbers  ICMJE 19-409
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Current Responsible Party Jennifer Snaman, MD, MS, Dana-Farber Cancer Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dana-Farber Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Snaman, MD, MS Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP