With Love, Grandma ("Con Cariño, Abuelita") Pilot Study
Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families
2 other identifiers
interventional
60
1 country
1
Brief Summary
The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 25, 2026
February 1, 2026
3.9 years
February 1, 2023
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Up to 3 months
Percent of modules completed by survivor-daughter dyads (acceptability)
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
Up to 3 months
Secondary Outcomes (3)
Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)
Baseline, Up to 3 months
Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire
Baseline, Up to 3 months
Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener
Baseline, Up to 3 months
Study Arms (2)
With Love, Grandma ("Con Cariño, Abuelita") Group
EXPERIMENTALCancer survivor-Daughter dyads randomized to the With Love, Grandma ("Con Cariño, Abuelita") group will access a digital lifestyle program that includes 8 modules of didactic, behavioral, and family communication/parenting/grandparenting content from smartphones over the course of 10-12 weeks.
Control Group
NO INTERVENTIONThis group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.
Interventions
Cancer survivor-Daughter dyads will log in to a secured website to access intervention content over a period of 10-12 weeks. The intervention will be delivered primarily through smartphones and will include 8 modules with didactic content on healthy lifestyle behaviors for cancer prevention and control, family behavior change content for setting weekly goals and self-monitoring health behaviors, and family communication and positive parenting/grandparenting content, all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period.
Eligibility Criteria
You may qualify if:
- Grandmother
- Self-identifies as Hispanic
- Diagnosis of breast cancer (stages I-III), endometrial or ovarian cancer (stages I-II)
- Completed active treatment (i.e., surgery, chemotherapy, and/or radiation)
- Body Mass Index (BMI) ≥ 25 (overweight range)
- Engages in \<150 minutes/week of moderate physical activity
- English or Spanish speaking
- Owns a mobile device with internet access (e.g., smartphone, tablet)
- Lives in South Florida
- Adult daughter of the identified cancer survivor (21 years of age or older)
- Has at least 1 living child ages ≤16 years old
- Body Mass Index (BMI) ≥ 25 (overweight range) OR engages in \<150 minutes/week of moderate physical activity
- English or Spanish speaking
- Owns a mobile device with internet access (e.g., smartphone, tablet)
- Lives in South Florida
You may not qualify if:
- Has been diagnosed with distant metastatic cancer
- Has not completed active treatment (i.e., surgery, chemotherapy, and/or radiation)
- Has uncontrolled schizophrenia or bipolar disorder
- Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions,wheelchair bound).
- Has uncontrolled schizophrenia or bipolar disorder
- Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions, wheelchair bound)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara M St. George, PhD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Public Health Sciences
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 10, 2023
Study Start
February 22, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share