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NCT Number: NCT05721976

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

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.

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Key information

Conditions

Cancer, Breast Activity, Motor Adnexal Diseases Behavior Body Weight Breast Diseases Breast Neoplasms Cancer, Ovary Cancer, Uterus Diet, Healthy Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Motor Activity Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Diseases Ovarian Neoplasms Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Sara M St. George, PhD

CONTACT

[email protected]

305-243-0726

Sara M St. George, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. 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

  2. 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

  1. 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.

  2. 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).

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Vanina Pavia, MD

CONTACT

[email protected]

305-243-0726

Sponsors and collaborators

Lead sponsor

University of Miami Sylvester Comprehensive Cancer Center

Other

Collaborators

  • The V Foundation for Cancer Research

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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