With Love, Grandma ("Con Cariño, Abuelita") Pilot Study

Not Applicable

Recruiting

• Conditions: Cancer, Breast; Cancer, Uterus; Obesity; Cancer, Ovary; Activity, Motor; Diet, Healthy
• Interventions: Behavioral: With Love, Grandma ("Con Cariño, Abuelita")

• Registration Number: NCT05721976
• Lead Sponsor: University of Miami Sylvester Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Study Start: 2023-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 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

Daughter of Cancer Survivor Inclusion Criteria:

• 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

Daughter of Cancer Survivor

Exclusion Criteria

• 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).

Cancer Survivor Exclusion Criteria:

• Has uncontrolled schizophrenia or bipolar disorder
• Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions, wheelchair bound)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Love, Grandma ("Con Cariño, Abuelita") Group	With Love, Grandma ("Con Cariño, Abuelita")	Cancer 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.

Primary Outcome Measures

Name	Time	Method
Percent of survivor-daughter dyads retained at post-intervention (feasibility)	Up to 3 months	Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Percent of modules completed by survivor-daughter dyads (acceptability)	Up to 3 months	Calculated as number of modules completed (of 8 total modules) by survivors and daughters

Secondary Outcome Measures

Name	Time	Method
Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire	Baseline, Up to 3 months	Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score).
Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener	Baseline, Up to 3 months	Participants will self-report dietary intake using the NCI All-Day Screener for fruit and vegetables and the percentage of energy from fat and fiber. Mean difference in cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute
Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)	Baseline, Up to 3 months	Participants will self-report walking and sitting time (hours and minutes per day) using three items from the IPAQ. Mean difference in total time spent walking and sitting will be calculated from these items. The result is not reported in scales. Higher scores indicate higher time spent walking and sitting in the last 7 days.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States