- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07454460
AYA-PeerConnect: Un intervento di coaching alla comunicazione per adolescenti e giovani adulti sopravvissuti al cancro (AYACS)
AYA-PeerConnect: Un Intervento di Coaching Comunicativo per Adolescenti/Giovani Adulti Sopravvissuti al Cancro (AYACS)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
- Milton S. Hershey Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intervention Feasibility (Quantitative)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Anxiety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pooja Rao, MD MSCE, Penn State College of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 28236
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Aggregate participant data that underlie the results reported in the study, after de-identification.
Periodo di condivisione IPD
1 years to 3 years following final publication.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .