- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07606443
COMUNICAR: Community-Led Family-Centered Communication for Cancer Survivorship Care
This study will test a novel intervention to facilitate family-centered communication among Hispanic/Latino (H/L) young adult childhood cancer survivors (YA-CCS), their support persons, and their clinicians through collaboration between the clinic and a community-based organization.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Stephanie Smith, MD, MPH
- Telefonnummer: 209-609-0208
- E-mail: smithsm@stanford.edu
Studiesteder
-
-
California
-
Palo Alto, California, Forenede Stater, 94304
- Rekruttering
- Stanford University
-
Kontakt:
- Stephanie Smith, MD, MPH
- Telefonnummer: 209-609-0208
- E-mail: smithsm@stanford.edu
-
Ledende efterforsker:
- Stephanie Smith, MD, MPH
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Childhood cancer survivor previously treated with chemotherapy and/or radiation therapy
- Currently age 18-25 years
- Identifies as Hispanic/Latino
- Currently ≥5 years post cancer diagnosis
- Fluent in English or Spanish
- Receives medical care at Stanford
- Lives within Jacob's Heart service area (zip codes within Monterey, Santa Cruz, Santa Clara, San Benito Counties: https://www.jacobsheart.org/service-area)
- Ability to understand and the willingness to provide written informed consent.
Exclusion Criteria:
1. Lack of proficiency in written and spoken English or Spanish
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: Family-Centered Communication
Young Adult Cancer Survivors (YA-CCS)-support person dyads receive a family-centered communication intervention delivered by a community health worker and coordinated around a standard-of-care survivorship clinic visit. |
A novel family-centered communication intervention designed to facilitate communication among Young Adult Cancer Survivors (YA-CCS), their chosen support person, and clinicians through collaboration between the clinic and a community-based organization. The intervention includes pre-visit and post-visit sessions delivered by a community health worker and timed around a standard-of-care survivorship clinic visit. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of invited young adult cancer survivor-support person dyads enrolled
Tidsramme: From recruitment initiation through completion of study enrollment, up to 24 months
|
Feasibility assessed by the proportion of invited dyads who enroll in the study. |
From recruitment initiation through completion of study enrollment, up to 24 months
|
|
Proportion of enrolled young adult cancer survivors completing all intervention components
Tidsramme: From intervention initiation through intervention completion, up to 3 weeks
|
Feasibility assessed by the proportion of enrolled young adult cancer survivor participants who complete all intervention components. |
From intervention initiation through intervention completion, up to 3 weeks
|
|
Mean Theoretical Framework of Acceptability questionnaire score
Tidsramme: Post-intervention, within 2 months after intervention completion
|
Acceptability assessed using participant-reported Theoretical Framework of Acceptability (TFA) questionnaire scores. Scores range from 1-5, with higher scores indicating greater acceptability. |
Post-intervention, within 2 months after intervention completion
|
|
Mean Satisfaction With Visit Preparation questionnaire score
Tidsramme: Post-intervention, within 2 months after intervention completion
|
Acceptability assessed using participant-reported Satisfaction With Visit Preparation questionnaire scores. Scores range from -10 to 10, with higher scores indicating greater satisfaction. |
Post-intervention, within 2 months after intervention completion
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stephanie Smith, MD, MPH, Stanford University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
- IRB-85827
- 5K08CA285829 (U.S. NIH-bevilling/kontrakt)
- NCI-2026-06570 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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