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Behavioral Intervention

Digital Health Program for Breast Cancer Survivors

N/A

Recruiting

Led By Sara M St. George, PhD

Research Sponsored by University of Miami Sylvester Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Grandmother

Has at least 1 living child ages ≤16 years old

Must not have

Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions, wheelchair bound)

Has been diagnosed with distant metastatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a digital program can help Hispanic women cancer survivors and their daughters improve lifestyle habits like exercise and diet.

Who is the study for?

This trial is for Hispanic female cancer survivors living in South Florida, who are overweight and have had breast (stages I-III), endometrial or ovarian cancer (stages I-II). They must have completed active treatment and engage in less than 150 minutes of moderate physical activity per week. Participants also need to be grandmothers with internet access on a mobile device. Adult daughters of these survivors can join if they're over 21 and have a child under 16.

What is being tested?

'With Love, Grandma' is a digital program aimed at improving lifestyle behaviors like physical activity and diet among Hispanic female cancer survivors and their adult daughters. The study will evaluate how practical, acceptable, and effective this web and mobile-phone-based intervention is.

What are the potential side effects?

Since the intervention involves lifestyle changes through a digital platform rather than medication or medical procedures, typical side effects associated with drugs are not expected. However, participants may experience discomfort from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a grandmother.

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I have a child who is 16 years old or younger.

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I have been diagnosed with early-stage breast, endometrial, or ovarian cancer.

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I have finished all my cancer treatments like surgery, chemo, or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot do physical activities on my own due to a severe health condition.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener

Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire

Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: With Love, Grandma ("Con Cariño, Abuelita") GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 Intervention

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

0 / 6Eligibility criteria met