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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP video decision aid | Experimental | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
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| Standard Care | Active Comparator | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP video decision aid | Behavioral | 10 minute video decision aid describing the goals-of-care options |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Snaman, MD, MS | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37433434 | Derived | 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. |
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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.
Data can be shared no earlier than 1 year following the date of publication
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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All enrolled participant completed a baseline survey prior to randomization
Patient recruited while in clinic; shift to almost all virtual recruitment in late 2020. Eligible individuals received a latter explaining the study and were called one week later to provide further details and determine interest.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care - Patients | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
Usual Care: Verbal description of the three types of care |
| FG001 | Standard Care - Caregivers | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
Usual Care: Verbal description of the three types of care |
| FG002 | ACP Video Decision Aid - Patients | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options |
| FG003 | ACP Video Decision Aid - Caregivers | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline and Immediately Post |
| |||||||||||||
| Three Month Follow-up |
|
participants were enrolled as AYA and caregiver dyads; presented here as individual participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care - Patient | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
Usual Care: Verbal description of the three types of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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) | Posted | Count of Participants | Participants | baseline, 3 months |
|
Through study completion; average of 3-months, ending 5/2022
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACP Video Decision Aid - Patient | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Snaman | Dana-Farber Cancer Institute | 617632-5548 | jennifer_snaman@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2021 | Sep 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2020 | Oct 7, 2022 | ICF_001.pdf |
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| Usual Care- | Other | Verbal description of the three types of care |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Standard Care - Caregiver | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
Usual Care: Verbal description of the three types of care |
| BG002 | ACP Video Decision Aid - Patient | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options |
| BG003 | ACP Video Decision Aid - Caregiver | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
| OG001 | Standard Care |
Usual Care: Verbal description of the three types of care |
|
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| Secondary | Increased Advance Care Planning (ACP) Conversations | Patients randomized to the video will have more ACP conversations and documentation after 3 months. | AYA participants that had data at 3-month follow-up | Posted | Count of Participants | Participants | Baseline and 3 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | ACP Video Decision Aid - Caregiver | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Standard Care - Patient | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
Usual Care-: Verbal description of the three types of care | 2 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Standard Care - Caregiver | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
Usual Care-: Verbal description of the three types of care | 0 | 25 | 0 | 25 | 0 | 25 |
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