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Clinical Trials/NCT05721976
NCT05721976
Recruiting
Not Applicable

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

University of Miami Sylvester Comprehensive Cancer Center1 site in 1 country60 target enrollmentFebruary 22, 2023

Overview

Phase
Not Applicable
Intervention
With Love, Grandma ("Con Cariño, Abuelita")
Conditions
Cancer, Breast
Sponsor
University of Miami Sylvester Comprehensive Cancer Center
Enrollment
60
Locations
1
Primary Endpoint
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Status
Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2023
End Date
December 31, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Miami Sylvester Comprehensive Cancer Center
Responsible Party
Principal Investigator
Principal Investigator

Sara StGeorge

Assistant Professor of Public Health Sciences

University of Miami Sylvester Comprehensive Cancer Center

Eligibility Criteria

Inclusion 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

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)

Arms & Interventions

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.

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

Control Group

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)
  • Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)(Baseline, Up to 3 months)

Study Sites (1)

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