Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05721976

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionCancer, Breast, Cancer, Uterus, Cancer, Ovary, Obesity, Activity, Motor, Diet, Healthy

Full registry criteria

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)

Treatments and study arms

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

Behavioral

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 outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Miami🇺🇸 Miami, Florida, United States
Sara M St. George, PhDContact
Sara M St. George, PhDPrincipal Investigator