- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454460
AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pooja Rao, MD MSCE
- Phone Number: 7175316012
- Email: prao2@pennstatehealth.psu.edu
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Milton S. Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant is currently ≥18-35 years old
- Participant is receiving cancer-directed care at Penn State Cancer Institute or Penn State Children's Hospital
- Participant has completed all cancer-directed therapy and is at least 1 year from end of cancer treatment (based on date of last cancer-directed treatment)
- Participant has access to a computer with internet capability
- Participant is fluent in written and spoken English
Exclusion Criteria:
- Participant is not fluent in written and spoken English
- Participant with cognitive inability to participant in the study as determined by the study team
- Participants with history of relapsed cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions
The intervention will use a combination of asynchronous communication coaching sessions, and AI Yoodli coach sessions.
|
Participants will complete asynchronous individual sessions for Visits 2-4. Each visit will include a 60-minute interactive didactic session using Rise 360 software, with a 20-minute Yoodli AI coaching session (both Rise 360 and Yoodli will be accessed via website). Rise 360 sessions will cover topics related to communication style, multiple goals theory and how to apply concepts learned in being good communicators. Yoodli AI coaching session will be completed for the corresponding Rise 360 session before moving to the next visit's session. The 20-minute Yoodli AI coaching sessions will include coaching from the Yoodli AI coach and practicing various peer conversation situations. These sessions will consolidate and reinforce concepts learned in the didactic sessions. The Yoodli AI coach is programmed with input on relationship style (a communication tool to assess communication style) to deliver personalized coaching. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication quality Multiple Goals Score
Time Frame: Baseline
|
Rating process for communication quality analysis (CQA) domains.
A domain score is calculated for each of the six communication quality domains (content, emotion, accommodation, engagement, relationship, and face).
Using the emotion domain as an example, the neutral score is assigned as a "1," and as participants express emotion (as per the definition above and further detailed in the CQA codebook) the score increases with the highest quality score being "7".
A domain score is assigned every five minutes for each of the six domains.
The full range for each measure is 6 (most neutral)-42 (highest quality).
|
Baseline
|
|
Communication quality Multiple Goals Score
Time Frame: Post intervention follow up visit (Up to a month)
|
Rating process for communication quality analysis (CQA) domains.
A domain score is calculated for each of the six communication quality domains (content, emotion, accommodation, engagement, relationship, and face).
Using the emotion domain as an example, the neutral score is assigned as a "1," and as participants express emotion (as per the definition above and further detailed in the CQA codebook) the score increases with the highest quality score being "7".
A domain score is assigned every five minutes for each of the six domains.
The full range for each measure is 6 (most neutral)-42 (highest quality).
|
Post intervention follow up visit (Up to a month)
|
|
Intervention Feasibility (Quantitative)
Time Frame: Post intervention follow up visit (Up to a month)
|
Quantitative feasibility will be collected based on visit attendance.
|
Post intervention follow up visit (Up to a month)
|
|
Intervention Feasibility (Qualitative)
Time Frame: Post intervention follow up visit (Up to a month)
|
Qualitative feasibility data will be collected from post-module mixed methods assessments, and exit interviews and focus groups.
|
Post intervention follow up visit (Up to a month)
|
|
Intervention Acceptability (Quantitative)
Time Frame: Post intervention follow up visit (Up to a month)
|
Quantitative acceptability will be collected using an acceptability questionnaire.
Quantitative acceptability will be integrated with qualitative data from post-module mixed methods assessments, and exit interviews and focus groups to understand intervention acceptability.
|
Post intervention follow up visit (Up to a month)
|
|
Intervention Acceptability (Qualitative)
Time Frame: Post intervention follow up visit (Up to a month)
|
Qualitative acceptability data will be collected from post-module mixed methods assessments, and exit interviews and focus groups.
|
Post intervention follow up visit (Up to a month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: Baseline
|
Anxiety will be measured using the Anxiety (Emotional Distress-Anxiety-Short Form 8a) measure from the Patient Reported Outcomes Measurement Information System (PROMIS).
It is an 8-item self-report questionnaire assessing anxiety symptoms over the past 7 days, including fear, tension, and worry.
It is scored on a 5-point Likert scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always).
|
Baseline
|
|
Anxiety
Time Frame: Post intervention follow up visit (Up to a month)
|
Anxiety will be measured using the Anxiety (Emotional Distress-Anxiety-Short Form 8a) measure from the Patient Reported Outcomes Measurement Information System (PROMIS).
It is an 8-item self-report questionnaire assessing anxiety symptoms over the past 7 days, including fear, tension, and worry.
It is scored on a 5-point Likert scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always).
|
Post intervention follow up visit (Up to a month)
|
|
Depression
Time Frame: Baseline
|
Depression will be measured using the Depression (Emotional Distress-Depression-Short Form 8b) measure from the Patient Reported Outcomes Measurement Information System (PROMIS).
It is an 8-item, self-report questionnaire assessing negative mood, views of self, and social cognition over the past seven days.
It uses a 5-point scale (1=Never, 5=Always) to measure severity.
|
Baseline
|
|
Depression
Time Frame: Post intervention follow up visit (Up to a month)
|
Depression will be measured using the Depression (Emotional Distress-Depression-Short Form 8b) measure from the Patient Reported Outcomes Measurement Information System (PROMIS).
It is an 8-item, self-report questionnaire assessing negative mood, views of self, and social cognition over the past seven days.
It uses a 5-point scale (1=Never, 5=Always) to measure severity.
|
Post intervention follow up visit (Up to a month)
|
|
Social isolation
Time Frame: Baseline
|
Social isolation will be measured by the validated Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Form 8a.The PROMIS Social Isolation 8a short form is a 8-item, self-report tool measuring perceived loneliness and detachment from others.
It uses a 5-point Likert scale (1=Never to 5=Always) to assess feelings of being avoided, excluded, or disconnected.
|
Baseline
|
|
Social isolation
Time Frame: Post intervention follow up visit (Up to a month)
|
Social isolation will be measured by the validated Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Form 8a.The PROMIS Social Isolation 8a short form is a 8-item, self-report tool measuring perceived loneliness and detachment from others.
It uses a 5-point Likert scale (1=Never to 5=Always) to assess feelings of being avoided, excluded, or disconnected.
|
Post intervention follow up visit (Up to a month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pooja Rao, MD MSCE, Penn State College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28236
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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