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

University of Miami Health System

Status: Enrolling

Conditions: Cancer, Ovary; Cancer, Breast; Cancer, Uterus; Activity, Motor; Obesity; Diet, Healthy

Treatments: Behavioral: With Love, Grandma ("Con Cariño, Abuelita")

Study type: Interventional

Funder types: Other

Identifiers

NCT05721976

2018-024 (Other Grant/Funding Number)

20201421

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

With Love, Grandma ("Con Cariño, Abuelita") Group

Experimental group

Description:

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.

Treatment:

Behavioral: With Love, Grandma ("Con Cariño, Abuelita")

Control Group

No Intervention group

Description:

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