Cancer, BreastNCT05721976
With Love, Grandma ("Con Cariño, Abuelita") Pilot Study
A study testing With Love, Grandma ("Con Cariño, Abuelita") in people with Cancer, Breast and Cancer, Uterus, run by University of Miami Sylvester Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cancer, Breast, Cancer, Uterus, Cancer, Ovary
- What is being tested?
- With Love, Grandma ("Con Cariño, Abuelita")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Sara M St. George, PhD, 305-243-0726, s.stgeorge@med.miami.edu
Sara M St. George, PhD
About this study
Official title: Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families
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.
- Conditions
- Cancer, Breast, Cancer, Uterus, Cancer, Ovary, Obesity, Activity, Motor, Diet, Healthy
- Being tested
- With Love, Grandma ("Con Cariño, Abuelita")
- Keywords
- Hispanic, family, digital health, cancer survivorship, physical activity, nutrition
- Medical subject headings
- Breast Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Love, Grandma ("Con Cariño, Abuelita")Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| With Love, Grandma ("Con Cariño, Abuelita") Group | Experimental | 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. Receives: Behavioral: With Love, Grandma ("Con Cariño, Abuelita") |
| Control Group | No intervention | This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Measured: 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
Measured: Up to 3 months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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
Measured: Baseline, Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start22 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami Sylvester Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The V Foundation for Cancer Research
- Responsible party
- Principal investigator, Sara StGeorge, University of Miami Sylvester Comprehensive Cancer Center
- Investigators
- Sara M St. George, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721976
- Sponsor's protocol ID
- 20201421
- Other IDs
- 2018-024
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families
- ClinicalTrials.gov ID
- NCT05721976
- Acronym / sponsor ID
- 20201421
- Conditions
- Cancer, Breast, Cancer, Uterus, Cancer, Ovary, Obesity, Activity, Motor, Diet, Healthy
- Keywords
- Hispanic, family, digital health, cancer survivorship, physical activity, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Miami Sylvester Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- The V Foundation for Cancer Research
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Love, Grandma ("Con Cariño, Abuelita") Group | Experimental | Behavioral: With Love, Grandma ("Con Cariño, Abuelita")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. |
| Control Group | No intervention | –This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | With Love, Grandma ("Con Cariño, Abuelita") Group |
Primary outcome
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Time frame: 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)
Time frame: Up to 3 months
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
3 secondary outcomes
Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, Up to 3 months
Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire
Time frame: Baseline, Up to 3 months
Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener
Time frame: Baseline, Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara M St. George, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With Love, Grandma ("Con Cariño, Abuelita") in people with Cancer, Breast and Cancer, Uterus, run by University of Miami Sylvester Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanina Pavia, MD (305-243-0726, vxp395@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of survivor-daughter dyads retained at post-intervention (feasibility) (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.