ACP video decision aid
Behavioral10 minute video decision aid describing the goals-of-care options
NCT Number: NCT04149704
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston Children's Hospital, Boston, Massachusetts, United States
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
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
10 minute video decision aid describing the goals-of-care options
Verbal description of the three types of 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
Time frame: Baseline and 3 months
Patients randomized to the video will have more ACP conversations and documentation after 3 months.
Dana-Farber Cancer Institute
Other
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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