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- Registre américain des essais cliniques
- Essai clinique NCT07454460
AYA-PeerConnect : Une intervention de coaching en communication pour les adolescents/jeunes adultes survivants du cancer (AYACS)
AYA-PeerConnect : Une intervention de coaching en communication pour les adolescents/jeunes adultes survivants du cancer (AJASC)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033
- Milton S. Hershey Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Feasibility (Quantitative)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
|
|
Communication quality Multiple Goals Score
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pooja Rao, MD MSCE, Penn State College of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 28236
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Aggregate participant data that underlie the results reported in the study, after de-identification.
Délai de partage IPD
1 years to 3 years following final publication.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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