- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07454460
AYA-PeerConnect: En kommunikationscoaching-intervention for adolescente/unge voksne kræftoverlevere (AYACS)
AYA-PeerConnect: En Kommunikationscoaching-intervention for Unge/Voksne med Kræft (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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Milton S. Hershey Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention Feasibility (Quantitative)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Social isolation
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pooja Rao, MD MSCE, Penn State College of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 28236
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Aggregate participant data that underlie the results reported in the study, after de-identification.
IPD-delingstidsramme
1 years to 3 years following final publication.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
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