Recruiting

Observational Study

Sponsor:

University of Miami Sylvester Comprehensive Cancer Center

Code:

NCT05721976

Conditions

Cancer, Breast

Cancer, Uterus

Cancer, Ovary

Obesity

Activity, Motor

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Cancer, Breast

Cancer, Uterus

Cancer, Ovary

Obesity

Activity, Motor

Study ID

NCT05721976

Start date

Feb 22, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Control Group

This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.

Interventions

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.

Primary outcome measure

  • Percent of survivor-daughter dyads retained at post-intervention (feasibility) [ Time Frame: Up to 3 months ]
  • Percent of modules completed by survivor-daughter dyads (acceptability) [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Vanina Pavia, MD

305-243-0726vxp395@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Sara M St. George, PhD

305-243-0726s.stgeorge@med.miami.edu

Principal Investigator:

Sara M St. George, PhD

More Information

Sponsor

University of Miami Sylvester Comprehensive Cancer Center

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Hispanic
  • family
  • digital health
  • cancer survivorship
  • physical activity
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami Sylvester Comprehensive Cancer Center on 2026-02-25.