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

Sponsor

University of Miami Sylvester Comprehensive Cancer Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05721976

Collaborator

The V Foundation for Cancer Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Cancer, Uterus Cancer, Ovary Obesity Activity, Motor Diet, Healthy	Behavioral: With Love, Grandma ("Con Cariño, Abuelita")	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Control Group This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ) [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.
Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire [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).
Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)