Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:22 AM
Study NCT ID:
NCT07454460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001185', 'term': 'Artificial Intelligence'}], 'ancestors': [{'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Communication quality Multiple Goals Score', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Communication quality Multiple Goals Score', 'timeFrame': 'Post intervention follow up visit (Up to a month)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Anxiety', 'timeFrame': 'Post intervention follow up visit (Up to a month)', 'description': '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).'}, {'measure': 'Depression', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Depression', 'timeFrame': 'Post intervention follow up visit (Up to a month)', 'description': '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.'}, {'measure': 'Social isolation', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Social isolation', 'timeFrame': 'Post intervention follow up visit (Up to a month)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication', 'Anxiety', 'Depression', 'Social Isolation'], 'conditions': ['Communication', 'Anxiety', 'Depression', 'Social Isolation']}, 'descriptionModule': {'briefSummary': 'This research is being done to test a communication coaching intervention 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.', 'detailedDescription': 'This study is being done to test a communication coaching intervention 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is currently ≥18-35 years old\n* Participant is receiving cancer-directed care at Penn State Cancer Institute or Penn State Children's Hospital\n* 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)\n* Participant has access to a computer with internet capability\n* Participant is fluent in written and spoken English\n\nExclusion Criteria:\n\n* Participant is not fluent in written and spoken English\n* Participant with cognitive inability to participant in the study as determined by the study team\n* Participants with history of relapsed cancer"}, 'identificationModule': {'nctId': 'NCT07454460', 'briefTitle': 'AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)', 'orgStudyIdInfo': {'id': '28236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions', 'description': 'The intervention will use a combination of asynchronous communication coaching sessions, and AI Yoodli coach sessions.', 'interventionNames': ['Behavioral: Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions']}], 'interventions': [{'name': 'Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions', 'type': 'BEHAVIORAL', 'description': "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.\n\nThe 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.", 'armGroupLabels': ['Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pooja Rao, MD MSCE', 'role': 'CONTACT', 'email': 'prao2@pennstatehealth.psu.edu', 'phone': '7175316012'}], 'overallOfficials': [{'name': 'Pooja Rao, MD MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '1 years to 3 years following final publication.', 'ipdSharing': 'YES', 'description': 'Aggregate participant data that underlie the results reported in the study, after de-identification.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Pediatrics', 'investigatorFullName': 'Pooja Rao', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}