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

N/ARecruitingNCT05721976

University of Miami Sylvester Comprehensive Cancer Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percent of survivor-daughter dyads retained at post-intervention (feasibility)

Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures

Time frame: Up to 3 months

Percent of modules completed by survivor-daughter dyads (acceptability)

Calculated as number of modules completed (of 8 total modules) by survivors and daughters

Time frame: Up to 3 months

Secondary Outcomes

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.

Time frame: Baseline, Up to 3 months

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).

Time frame: Baseline, Up to 3 months

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

Time frame: Baseline, Up to 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts