Back to resultsWith Love, Grandma ("Con Cariño, Abuelita") Pilot Study
Primary Purpose
Cancer, Breast, Cancer, Uterus, Cancer, Ovary
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
With Love, Grandma ("Con Cariño, Abuelita")
Sponsored by
About this trial
This is an interventional treatment trial for Cancer, Breast focused on measuring Hispanic, family, digital health, cancer survivorship, physical activity, nutrition
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)
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
With Love, Grandma ("Con Cariño, Abuelita") Group
Control Group
Arm 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.
This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.
Outcomes
Primary Outcome Measures
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Percent of modules completed by survivor-daughter dyads (acceptability)
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
Secondary Outcome Measures
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.
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).
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
Full Information
NCT ID
NCT05721976
First Posted
February 1, 2023
Last Updated
July 12, 2023
Sponsor
University of Miami Sylvester Comprehensive Cancer Center
Collaborators
The V Foundation for Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT05721976
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami Sylvester Comprehensive Cancer Center
Collaborators
The V Foundation for Cancer Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer, Uterus, Cancer, Ovary, Obesity, Activity, Motor, Diet, Healthy
Keywords
Hispanic, family, digital health, cancer survivorship, physical activity, nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With Love, Grandma ("Con Cariño, Abuelita") Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.
Intervention Type
Behavioral
Intervention Name(s)
With Love, Grandma ("Con Cariño, Abuelita")
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Description
Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Time Frame
Up to 3 months
Title
Percent of modules completed by survivor-daughter dyads (acceptability)
Description
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
Baseline, Up to 3 months
Title
Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire
Description
Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score).
Time Frame
Baseline, Up to 3 months
Title
Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener
Description
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
Time Frame
Baseline, Up to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanina Pavia, MD
Phone
305-243-0726
Email
vxp395@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M St. George, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara M St. George, PhD
Phone
305-243-0726
Email
s.stgeorge@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Sara M St. George, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
With Love, Grandma ("Con Cariño, Abuelita") Pilot Study
We'll reach out to this number within 24 hrs