Advanced CancerNCT04149704

Videos for Advance Care Planning in Young Adults

A study testing ACP video decision aid in people with Advanced Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Cancer
What is being tested?: ACP video decision aid
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 3 sitesUnited States
Study dates: 13 Dec 2019to 5 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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.
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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Boston Children's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115

Other trials in United States

About this study

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

Questionnaires
Video
Phone Interview

Read the 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.

Conditions: Advanced Cancer
Being tested: ACP video decision aid, Usual Care-
Keywords: Advanced Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACP video decision aidBehavioural
10 minute video decision aid describing the goals-of-care options
Usual Care-Other
Verbal description of the three types of care

Study groups in NCT04149704
Study group	Role	What they receive
ACP video decision aid	Experimental	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 Receives: Behavioral: ACP video decision aid
Standard Care	Active comparator	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 Receives: Other: Usual Care-

What is being measured

The primary outcome is the main question the study is designed to answer.

Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
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
Measured: baseline, 3 months

Secondary outcomes (1)

Increased Advance Care Planning (ACP) Conversations
Patients randomized to the video will have more ACP conversations and documentation after 3 months.
Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20195 May 2022

First posted4 Nov 2019
Study start13 Dec 2019
Primary completion5 May 2022
Study completion5 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04149704
Sponsor's protocol ID: 19-409
Status last verified: Dec 2024
First submitted: 31 Oct 2019
Last updated: 20 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Snaman JM, Feifer D, Helton G, Chang Y, El-Jawahri A, Volandes AE, Wolfe J. A Pilot Randomized Trial of an Advance Care Planning Video Decision Support Tool for Adolescents and Young Adults With Advanced Cancer. J Natl Compr Canc Netw. 2023 Jul;21(7):715-723.e17. doi: 10.6004/jnccn.2023.7021.
PubMed 37433434

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Videos for Advance Care Planning in Young Adults
ClinicalTrials.gov ID: NCT04149704
Acronym / sponsor ID: 19-409
Conditions: Advanced Cancer
Keywords: Advanced Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Study start: 13 Dec 2019 (actual)
Primary completion: 5 May 2022 (actual)
Study completion: 5 May 2022 (actual)
First posted: 4 Nov 2019 (actual)
Results: Posted 20 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACP video decision aid	Experimental	Behavioral: ACP video decision aidThe 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
Standard Care	Active comparator	Other: Usual 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (2 listed)

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.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACP video decision aid10 minute video decision aid describing the goals-of-care options	Behavioural	ACP video decision aid
Usual Care-Verbal description of the three types of care	Other	Standard Care

Primary outcome

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

1 secondary outcome

Increased Advance Care Planning (ACP) Conversations
Time frame: Baseline and 3 months

Results and safety

Results posted to the registry on 20 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care - Patients	26	26
Standard Care - Caregivers	25	25
ACP Video Decision Aid - Patients	25	25
ACP Video Decision Aid - Caregivers	26	26

Primary outcome: Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)

Time frame: baseline, 3 months. Count of participants. Unit: Participants

Measure	ACP Video Decision Aid n = 25	Standard Care n = 25
Concordance in goals of care pre intervention: Number of dyads with concordant goals of care	20	15
Concordance in goals of care pre intervention: Number of dyads with disconcordant goals of care	5	10
Concordance in goals of care post intervention: Number of dyads with concordant goals of care	13	15
Concordance in goals of care post intervention: Number of dyads with disconcordant goals of care	12	10
Concordance in goals of care 3 months post intervention: Number of dyads with concordant goals of care	10	9
Concordance in goals of care 3 months post intervention: Number of dyads with disconcordant goals of care	15	16

Population analysed: Analyzed as dyad. If one individual of the dyad did not complete study procedures, those results were not analyzed. One AYA assigned to standard care did not have a caregiver that was able to participate. One AYA of a caregiver assigned to video decision aid was unable to participate. As the unit of measurement was the DYAD, these two individuals (one standard arm, one video) were not analyzed although they did complete enrollment and baseline and follow-up assessments (but not 3 month)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through study completion; average of 3-months, ending 5/2022. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACP Video Decision Aid - Patient	0 of 25 (0%)	0 of 25 (0%)	0 of 25
ACP Video Decision Aid - Caregiver	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Standard Care - Patient	0 of 25 (0%)	0 of 25 (0%)	2 of 25
Standard Care - Caregiver	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37433434Snaman JM, Feifer D, Helton G, Chang Y, El-Jawahri A, Volandes AE, Wolfe J. A Pilot Randomized Trial of an Advance Care Planning Video Decision Support Tool for Adolescents and Young Adults With Advanced Cancer. J Natl Compr Canc Netw. 2023 Jul;21(7):715-723.e17. doi: 10.6004/jnccn.2023.7021.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Snaman, MD, MS principal investigator

Dana-Farber Cancer Institute

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACP video decision aid in people with Advanced Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04149704, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.