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Recruiting NCT05721976

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

No phase Interventional Cancer, Breast Cancer, Uterus Cancer, Ovary Obesity

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: With Love, Grandma ("Con Cariño, Abuelita").
Who it may be relevant to
Registry conditions: Cancer, Breast, Cancer, Uterus, Cancer, Ovary, Obesity. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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 i

Primary outcome measures

  • Percent of survivor-daughter dyads retained at post-intervention (feasibility) [Time frame: Up to 3 months]
  • Percent of modules completed by survivor-daughter dyads (acceptability) [Time frame: Up to 3 months]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05721976 · 20201421 · 2018-024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗