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Intervention For AYAS With Cancer Risk Syndromes (AYA-RISE)

Primary Purpose

Cancer Risk Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AYA-RISE Adolescents and Young Adults Risk Information and Screening Education
Standard clinical visit for genetic counseling
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cancer Risk Syndrome focused on measuring Cancer Risk Syndrome, LiFraumeni Syndrome Association (LFSA) Youth Conference

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Across all study aims, we will enroll AYA patients, family members/caregivers, and providers.

AIM 1, PART 1 - STAKEHOLDER INTERVIEWS

AYA Patients

  1. Ages 12-24 years, inclusive
  2. Diagnosed with a cancer risk syndrome
  3. English-speaking and -reading
  4. Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference
  5. Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater
  6. Not receiving active cancer therapy

Family caregivers-Inclusion Criteria

  1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
  2. English-speaking and -reading
  3. At any of the study sites

Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists)

  1. English-speaking and reading
  2. Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites

AIM 1, PART 2 - INTERVENTION PILOT

AYA Patients

  1. Ages 12-24 years, inclusive
  2. Diagnosed with a cancer risk syndrome
  3. English-speaking and -reading
  4. Receiving care at Dana-Farber Cancer Institute
  5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
  6. Not receiving active cancer therapy
  7. Did not participate in a stakeholder interview

Eligibility notes:

  • Family caregivers of participating 12-17y patients will be eligible to participate in the pilot
  • 12-17y patients can participate without a family member if both the patient and family member agree.
  • Patients 18-24y will have the option to participate with or without a family member.

AIM 2 - RANDOMIZED TRIAL

AYA Patients

  1. Ages 12-24 years, inclusive
  2. Diagnosed with a cancer risk syndrome
  3. English-speaking and reading
  4. Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites
  5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
  6. Not receiving active cancer therapy
  7. Did not participate in either part of Aim 1 (interview or pilot)

Family caregivers

  1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
  2. English-speaking and -reading
  3. At any of the study sites
  4. Did not participate in either part of Aim 1 (interview or pilot)

AIM 3 - SEMI-STRUCTURED INTERVIEWS AYA Patients, Family Caregivers, Providers, and Site PIs

  1. Participated in the intervention arm of Aim 2, or
  2. Is a site principal investigator at one of the 4 participating study sites

Sites / Locations

  • Emory University School of MedicineRecruiting
  • University of ChicagoRecruiting
  • Boston Children's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University of Utah, Huntsman Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

Aim 1-Part 1 Stakeholder Interview

Aim 1-Part 2

Aim 2-Genetic Counseling

Aim 2- Genetic Counseling with AYA-RISE

Aim 3 Semi-structured interviews

Arm Description

This arm will focus on finding the best format for the study intervention (called AYA-RISE) whether AYA-RISE is easy to use; and whether patients, family caregivers, and providers find AYA-RISE acceptable. The research study procedures include: Using and reviewing AYA-RISE Participating in audio-recorded, 30-minute interviews

This arm is a pilot study of the study intervention (called AYA-RISE). The activities involved in this part of the study are: Baseline Questionnaire Using and reviewing AYA-RISE Follow-up Questionnaire Brief interviews to get feedback on AYA-RISE

The names of the study activities involved in this study are: Baseline Questionnaire Follow-up Questionnaire Medical record review The study procedures will all take place on the day of the patient's regularly scheduled clinic visit. Participants will be in this research study for up to 1 year.

The names of the study activities involved in this study are: Baseline Questionnaire Follow-up Questionnaire Medical record review Using the study intervention, AYA-RISE The study procedures will all take place on the day of the patient's regularly scheduled clinic visit. Participants will be in this research study for up to 1 year.

Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.

Outcomes

Primary Outcome Measures

Percentage of Consenting AYA use AYA-RISE
The feasibility (>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Percentage of Acceptability
Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.)
Change in patient knowledge of cancer risk and screening
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Change in psychological distress
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Patient ownership of information in the intervention arm
determined as % AYAs able to store and access portal information
Participants who followed up for recommended care
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Utilization of AYA-RISE
Chat transcripts and patient portal access
Acceptability of AYA-RISE
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Adoption of AYA-RISE
An analytic matrix on intervention design will be used to code of semi-structured interviews - Semi-structured interview of Providers and Clinic Leaders Were patients and providers willing to try the intervention? Would they want to continue to use the intervention?
Practicality of Using AYA-RISE
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview Is it practical to continue to use AYA-RISE within constraints of clinic, provider, and patient/family needs?
Fidelity of AYA-RISE
Site RA: Observation and Checklist Does actual implementation match the planned process?
Sustainability of AYA-Rise
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
May 9, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04323774
Brief Title
Intervention For AYAS With Cancer Risk Syndromes
Acronym
AYA-RISE
Official Title
AYA-RISE: Refining a Scalable, Patient- and Family-centered Intervention to Improve Cancer Risk Communication and Decision-making Among Adolescents and Young Adults With Cancer Risk Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is being done because there is a need to improve cancer risk communication and decision-making among adolescents and young adults. In this study, the investigators are looking at whether using a chatbot and online portal for cancer risk information helps improve communication and decision-making. Over 70,000 adolescents and young adults (AYAs) are diagnosed with cancer in the U.S. every year and up to 10% have genetic changes (or, mutations) that put them at a higher risk of developing new cancers during their lifetimes. These genetic mutations can result in cancer risk syndromes (such as, Lynch Syndrome or Li-Fraumeni Syndrome). Identifying cancer risk syndromes can allow for screening and early diagnosis of future cancers, which could ultimately save lives and offer more care choices for patients. As a result, genetic counseling and testing for cancer risk syndromes is being recommended more for Adolescents and Young Adults with new cancer diagnoses, regardless of family history. This research study to develop an intervention called AYA-RISE that aims to assist AYAs with cancer risk communication and decision-making around their caregivers.
Detailed Description
This research study involves three aims (Aims 1, 2, and 3). Aim 1, Part 1, which focuses on finding the best format for the study intervention (called AYA-RISE); whether AYA-RISE is easy to use; and whether patients, family caregivers, and providers find AYA-RISE acceptable.The research study procedures include: Using and reviewing AYA-RISE, Participating in audio-recorded, 30-minute interviews Aim 1, Part 2, which is a pilot study of the study intervention (called AYA-RISE). In this pilot study, the investigators are looking at whether AYA-RISE is easy to use and what participants think of it. -- The activities involved in this part of the study are: Baseline Questionnaire Using and reviewing AYA-RISE Follow-up Questionnaire Brief feedback interviews on AYA-RISE In Aim 2, participants will be randomized trial into one of two groups; Group 1: Standard Genetic Counseling/follow-up visit or Group 2 : Standard Genetic Counseling/follow-up visit and Access to AYA-Rise Aim 3: Semi-Structured Interviews: Evaluate implementation outcomes using 28 semi-structured interviews with patients, family members, providers, and site principal investigators

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Risk Syndrome
Keywords
Cancer Risk Syndrome, LiFraumeni Syndrome Association (LFSA) Youth Conference

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1-Part 1 Stakeholder Interview
Arm Type
No Intervention
Arm Description
This arm will focus on finding the best format for the study intervention (called AYA-RISE) whether AYA-RISE is easy to use; and whether patients, family caregivers, and providers find AYA-RISE acceptable. The research study procedures include: Using and reviewing AYA-RISE Participating in audio-recorded, 30-minute interviews
Arm Title
Aim 1-Part 2
Arm Type
Experimental
Arm Description
This arm is a pilot study of the study intervention (called AYA-RISE). The activities involved in this part of the study are: Baseline Questionnaire Using and reviewing AYA-RISE Follow-up Questionnaire Brief interviews to get feedback on AYA-RISE
Arm Title
Aim 2-Genetic Counseling
Arm Type
Active Comparator
Arm Description
The names of the study activities involved in this study are: Baseline Questionnaire Follow-up Questionnaire Medical record review The study procedures will all take place on the day of the patient's regularly scheduled clinic visit. Participants will be in this research study for up to 1 year.
Arm Title
Aim 2- Genetic Counseling with AYA-RISE
Arm Type
Experimental
Arm Description
The names of the study activities involved in this study are: Baseline Questionnaire Follow-up Questionnaire Medical record review Using the study intervention, AYA-RISE The study procedures will all take place on the day of the patient's regularly scheduled clinic visit. Participants will be in this research study for up to 1 year.
Arm Title
Aim 3 Semi-structured interviews
Arm Type
No Intervention
Arm Description
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.
Intervention Type
Behavioral
Intervention Name(s)
AYA-RISE Adolescents and Young Adults Risk Information and Screening Education
Other Intervention Name(s)
AYA-RISE
Intervention Description
A chatbot is a computer program that can chat with humans. The text the chatbot uses to talk with humans was created by real people, but the chatbot itself is not a real person. A company called Clear Genetics developed the original chatbot and patient portal, and this study team customized it for this research study.
Intervention Type
Behavioral
Intervention Name(s)
Standard clinical visit for genetic counseling
Intervention Description
Standard clinical visit for genetic counseling and follow up
Primary Outcome Measure Information:
Title
Percentage of Consenting AYA use AYA-RISE
Description
The feasibility (>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Time Frame
2 years
Title
Percentage of Acceptability
Description
Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.)
Time Frame
2 years
Title
Change in patient knowledge of cancer risk and screening
Description
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Time Frame
baseline to post-visit surveys up to 24 months
Title
Change in psychological distress
Description
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Time Frame
baseline to post-visit surveys up to 24 months
Title
Patient ownership of information in the intervention arm
Description
determined as % AYAs able to store and access portal information
Time Frame
24 Months
Title
Participants who followed up for recommended care
Description
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Time Frame
screening and follow-up over the next year up to 24 Months
Title
Utilization of AYA-RISE
Description
Chat transcripts and patient portal access
Time Frame
2 Years
Title
Acceptability of AYA-RISE
Description
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Time Frame
2 Years
Title
Adoption of AYA-RISE
Description
An analytic matrix on intervention design will be used to code of semi-structured interviews - Semi-structured interview of Providers and Clinic Leaders Were patients and providers willing to try the intervention? Would they want to continue to use the intervention?
Time Frame
2 Years
Title
Practicality of Using AYA-RISE
Description
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview Is it practical to continue to use AYA-RISE within constraints of clinic, provider, and patient/family needs?
Time Frame
2 Years
Title
Fidelity of AYA-RISE
Description
Site RA: Observation and Checklist Does actual implementation match the planned process?
Time Frame
2 Years
Title
Sustainability of AYA-Rise
Description
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Across all study aims, we will enroll AYA patients, family members/caregivers, and providers. AIM 1, PART 1 - STAKEHOLDER INTERVIEWS AYA Patients Ages 12-24 years, inclusive Diagnosed with a cancer risk syndrome English-speaking and -reading Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater Not receiving active cancer therapy Family caregivers-Inclusion Criteria Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes English-speaking and -reading At any of the study sites Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists) English-speaking and reading Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites AIM 1, PART 2 - INTERVENTION PILOT AYA Patients Ages 12-24 years, inclusive Diagnosed with a cancer risk syndrome English-speaking and -reading Receiving care at Dana-Farber Cancer Institute Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater Not receiving active cancer therapy Did not participate in a stakeholder interview Eligibility notes: Family caregivers of participating 12-17y patients will be eligible to participate in the pilot 12-17y patients can participate without a family member if both the patient and family member agree. Patients 18-24y will have the option to participate with or without a family member. AIM 2 - RANDOMIZED TRIAL AYA Patients Ages 12-24 years, inclusive Diagnosed with a cancer risk syndrome English-speaking and reading Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater Not receiving active cancer therapy Did not participate in either part of Aim 1 (interview or pilot) Family caregivers Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes English-speaking and -reading At any of the study sites Did not participate in either part of Aim 1 (interview or pilot) AIM 3 - SEMI-STRUCTURED INTERVIEWS AYA Patients, Family Caregivers, Providers, and Site PIs Participated in the intervention arm of Aim 2, or Is a site principal investigator at one of the 4 participating study sites
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Mack, MD
Phone
(617) 632-6622
Email
JMACK@PARTNERS.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mack, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Porter, MD
Email
chris.porter@emory.edu
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Henderson, MD
Email
thenderson@peds.bsd.uchicago.edu
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Mack, MD
Phone
617-632-6622
Email
JMACK@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Jennifer Mack, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Mack, MD
Phone
617-632-6622
Email
JMACK@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Jennifer Mack, MD
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Maese, DO
Email
luke.maese@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Intervention For AYAS With Cancer Risk Syndromes

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