Clinical trial NCT05721976: With Love, Grandma ("Con Cariño, Abuelita") Pilot Study
Official title: Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Cancer, Uterus
Cancer, Ovary
Obesity
Activity, Motor
Diet, Healthy
Keywords: Hispanic
family
digital health
cancer survivorship
physical activity
nutrition
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The V Foundation for Cancer Research
First posted: 2023-02-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Percent of survivor-daughter dyads retained at post-intervention (feasibility)
timeFrame: Up to 3 months
measure: Percent of modules completed by survivor-daughter dyads (acceptability)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, Up to 3 months
measure: Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire
timeFrame: Baseline, Up to 3 months
measure: Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener
timeFrame: Baseline, Up to 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sara M St. George, PhD
role: PRINCIPAL_INVESTIGATOR
References: