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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of modules completed by survivor-daughter dyads (acceptability)
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Secondary outcome measures
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)

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.

Find a Location

Who is running the clinical trial?

University of Miami Sylvester Comprehensive Cancer CenterLead Sponsor
9 Previous Clinical Trials
2,559 Total Patients Enrolled
The V Foundation for Cancer ResearchOTHER
18 Previous Clinical Trials
1,208 Total Patients Enrolled
1 Trials studying Ovarian Cancer
20 Patients Enrolled for Ovarian Cancer
Sara M St. George, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials

Media Library

With Love, Grandma ("Con Cariño, Abuelita") (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05721976 — N/A
Ovarian Cancer Research Study Groups: Control Group, With Love, Grandma ("Con Cariño, Abuelita") Group
Ovarian Cancer Clinical Trial 2023: With Love, Grandma ("Con Cariño, Abuelita") Highlights & Side Effects. Trial Name: NCT05721976 — N/A
With Love, Grandma ("Con Cariño, Abuelita") (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721976 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment slots still available for this research project?

"The trial, which was initially unveiled on May 1st 2023 and last edited February 1st, is not actively recruiting patients. Nevertheless, there are currently 3994 other clinical trials in search of participants."

Answered by AI

Who else is applying?

What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
With Love, Grandma ("Con Cariño, Abuelita") Pilot Study
Sara StGeorge 2023. "With Love, Grandma ("Con Cariño, Abuelita") Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721976.
All > Uterine Cancer
~4 spots leftby May 2024
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