Advanced Cancer
Conditions
Keywords
Advanced Cancer
Brief 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
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.
Interventions
BEHAVIORALACP video decision aid
10 minute video decision aid describing the goals-of-care options
OTHERUsual Care-
Verbal description of the three types of care
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | 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
| Measure | Time frame | Description |
|---|---|---|
| Increased Advance Care Planning (ACP) Conversations | Baseline and 3 months | Patients randomized to the video will have more ACP conversations and documentation after 3 months. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All enrolled participant completed a baseline survey prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Standard Care - Patient 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
Usual Care: Verbal description of the three types of care | 26 |
| Standard Care - Caregiver 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
Usual Care: Verbal description of the three types of care | 26 |
| ACP Video Decision Aid - Patient 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
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options | 24 |
| ACP Video Decision Aid - Caregiver 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
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options | 24 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Three Month Follow-up | Death | 2 | 0 | 0 | 0 |
| Three Month Follow-up | Lost to Follow-up | 1 | 4 | 5 | 5 |
| Three Month Follow-up | Not completed as dyad (one member of dayd did not complete initial timepoint so withdrawn from study | 1 | 0 | 0 | 1 |
| Three Month Follow-up | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Standard Care - Patient | Total | ACP Video Decision Aid - Caregiver | ACP Video Decision Aid - Patient | Standard Care - Caregiver |
|---|---|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 6.1 | 37.6 years STANDARD_DEVIATION 11.5 | 43.0 years STANDARD_DEVIATION 13.8 | 32.7 years STANDARD_DEVIATION 5.6 | 41.3 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 93 Participants | 23 Participants | 22 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 21 Participants | 84 Participants | 20 Participants | 21 Participants | 22 Participants |
| Region of Enrollment United States | 26 participants | 100 participants | 24 participants | 24 participants | 26 participants |
| Sex: Female, Male Female | 16 Participants | 58 Participants | 14 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 42 Participants | 10 Participants | 10 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 2 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: baseline, 3 months
Population: 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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ACP Video Decision Aid | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care pre intervention | Number of dyads with concordant goals of care | 20 Participants |
| ACP Video Decision Aid | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care pre intervention | Number of dyads with disconcordant goals of care | 5 Participants |
| ACP Video Decision Aid | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care post intervention | Number of dyads with concordant goals of care | 13 Participants |
| ACP Video Decision Aid | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care post intervention | Number of dyads with disconcordant goals of care | 12 Participants |
| ACP Video Decision Aid | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care 3 months post intervention | Number of dyads with concordant goals of care | 10 Participants |
| ACP Video Decision Aid | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care 3 months post intervention | Number of dyads with disconcordant goals of care | 15 Participants |
| Standard Care | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care 3 months post intervention | Number of dyads with concordant goals of care | 9 Participants |
| Standard Care | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care pre intervention | Number of dyads with concordant goals of care | 15 Participants |
| Standard Care | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care post intervention | Number of dyads with disconcordant goals of care | 10 Participants |
| Standard Care | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care pre intervention | Number of dyads with disconcordant goals of care | 10 Participants |
| Standard Care | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care 3 months post intervention | Number of dyads with disconcordant goals of care | 16 Participants |
| Standard Care | Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care) | Concordance in goals of care post intervention | Number of dyads with concordant goals of care | 15 Participants |
Secondary
Increased Advance Care Planning (ACP) Conversations
Patients randomized to the video will have more ACP conversations and documentation after 3 months.
Time frame: Baseline and 3 months
Population: AYA participants that had data at 3-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACP Video Decision Aid | Increased Advance Care Planning (ACP) Conversations | Change in number of AYAs that engaged in ACP conversations following the intervention to 3-months | 13 Participants |
| ACP Video Decision Aid | Increased Advance Care Planning (ACP) Conversations | Change in number of AYAs that had ACP documentation from baseline to 3 months | 2 Participants |
| Standard Care | Increased Advance Care Planning (ACP) Conversations | Change in number of AYAs that engaged in ACP conversations following the intervention to 3-months | 13 Participants |
| Standard Care | Increased Advance Care Planning (ACP) Conversations | Change in number of AYAs that had ACP documentation from baseline to 3 months | 4 Participants |