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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721976
• Other study ID #: 20201421
• Secondary ID: 2018-024
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: Vanina Pavia, MD
• Phone: 305-243-0726
• Email: vxp395[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Activity, Motor
• Breast Neoplasms
• Cancer, Breast
• Cancer, Uterus
• Diet, Healthy
• Obesity
• Ovarian Neoplasms
• Uterine Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center	The V Foundation for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of survivor-daughter dyads retained at post-intervention (feasibility)	Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures	Up to 3 months
Primary	Percent of modules completed by survivor-daughter dyads (acceptability)	Calculated as number of modules completed (of 8 total modules) by survivors and daughters	Up to 3 months
Secondary	Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)	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.	Baseline, Up to 3 months
Secondary	Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire	Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score).	Baseline, Up to 3 months
Secondary	Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener	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	Baseline, Up to 3 months