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OpenTrials
Completed

NCT Number: NCT04149704

Videos for Advance Care Planning in Young Adults

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

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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

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ACP video decision aid

Behavioral

10 minute video decision aid describing the goals-of-care options

Usual Care-

Other

Verbal description of the three types of care

Primary outcomes

  1. Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)

    Time frame: baseline, 3 months

    AYA with advanced cancer and caregivers randomized to the video will have higher concordance in their stated goals of care between patients and caregivers at 3 month compared to baseline

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2019
Registry last updated
Jan 20, 2025

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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