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

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

NCT ID: NCT05721976

Condition: Cancer, Breast
Cancer, Uterus
Cancer, Ovary
Obesity
Activity, Motor
Diet, Healthy

Conditions: Official terms:
Breast Neoplasms
Uterine Neoplasms
Ovarian Neoplasms

Conditions: Keywords:
Hispanic
family
digital health
cancer survivorship
physical activity
nutrition

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: With Love, Grandma ("Con Cariño, Abuelita")
Description: 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.
Arm group label: With Love, Grandma ("Con Cariño, Abuelita") Group

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.

Criteria for eligibility:
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)

Gender: Female

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Miami

Address:
City: Miami
Zip: 33136
Country: United States

Status: Recruiting

Contact:
Last name: Sara M St. George, PhD

Phone: 305-243-0726
Email: s.stgeorge@med.miami.edu

Investigator:
Last name: Sara M St. George, PhD
Email: Principal Investigator

Start date: February 22, 2023

Completion date: May 31, 2025

Lead sponsor:
Agency: University of Miami Sylvester Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: The V Foundation for Cancer Research
Agency class: Other

Source: University of Miami

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05721976