Videos for Advance Care Planning in Young Adults

Advanced Cancer Clinical Trial

Official title:

Videos for Advance Care Planning in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149704
• Other study ID #: 19-409
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: May 5, 2022

Study information

• Verified date: May 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased Concordance Rate	AYA with advanced cancer and caregivers randomized to the video will have higher concordance between patients and caregivers	baseline, 3 months
Secondary	Increased Advance Care Planning (ACP) Conversations	Patients randomized to the video will have more ACP conversations and documentation after 3 months.	Baseline and 3 months