- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Smith, MD, MPH
- Phone Number: 209-609-0208
- Email: smithsm@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Recruiting
- Stanford University
-
Contact:
- Stephanie Smith, MD, MPH
- Phone Number: 209-609-0208
- Email: smithsm@stanford.edu
-
Principal Investigator:
- Stephanie Smith, MD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of invited young adult cancer survivor-support person dyads enrolled
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Smith, MD, MPH, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-85827
- 5K08CA285829 (U.S. NIH Grant/Contract)
- NCI-2026-06570 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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