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

February 24, 2026 updated by: Sara StGeorge, University of Miami Sylvester Comprehensive Cancer Center

Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Sara M St. George, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Cancer Survivor 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With Love, Grandma ("Con Cariño, Abuelita") Group
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.
Behavioral: With Love, Grandma ("Con Cariño, Abuelita")
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.
No Intervention: Control Group
This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Time Frame: Up to 3 months
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)
Time Frame: Up to 3 months
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)
Time Frame: 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.
Baseline, Up to 3 months
Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire
Time Frame: 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).
Baseline, Up to 3 months
Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener
Time Frame: 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
Baseline, Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami Sylvester Comprehensive Cancer Center

Collaborators

The V Foundation for Cancer Research

Investigators

  • Principal Investigator: Sara M St. George, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201421
  • 2018-024 (Other Grant/Funding Number: V Foundation for Cancer Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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