We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: ACP video decision aid Other: Usual Care- Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Videos for Advance Care Planning in Young Adults
Actual Study Start Date : December 13, 2019
Actual Primary Completion Date : May 5, 2022
Actual Study Completion Date : May 5, 2022

Arm Intervention/treatment
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
Other: Usual Care-
Verbal description of the three types of care




Primary Outcome Measures :
  1. 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


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149704


Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Snaman, MD, MS Dana-Farber Cancer Institute
Layout table for additonal information
Responsible Party: Jennifer Snaman, MD, MS, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04149704    
Other Study ID Numbers: 19-409
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
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
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Snaman, MD, MS, Dana-Farber Cancer Institute:
Advanced Cancer