NCT07454460

Brief Summary

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

March 2, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

CommunicationAnxietyDepressionSocial Isolation

Outcome Measures

Primary Outcomes (6)

  • Intervention Feasibility (Quantitative)

    Quantitative feasibility will be collected based on visit attendance.

    Post intervention follow up visit (Up to a month)

  • Intervention Feasibility (Qualitative)

    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)

    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)

    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)

  • Communication quality Multiple Goals Score

    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

    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)

Secondary Outcomes (6)

  • Anxiety

    Baseline

  • Anxiety

    Post intervention follow up visit (Up to a month)

  • Depression

    Baseline

  • Depression

    Post intervention follow up visit (Up to a month)

  • Social isolation

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions

EXPERIMENTAL

The intervention will use a combination of asynchronous communication coaching sessions, and AI Yoodli coach sessions.

Behavioral: Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions

Interventions

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.

Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

CommunicationAnxiety DisordersDepressionSocial Isolation

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

BehaviorMental DisordersBehavioral SymptomsSocial Behavior

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Pooja Rao, MD MSCE

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Pediatrics

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Aggregate participant data that underlie the results reported in the study, after de-identification.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
1 years to 3 years following final publication.

Locations