With Love, Grandma ("Con Cariño, Abuelita") Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorUniversity of Miami Sylvester Comprehensive Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
With Love, Grandma ("Con Cariño, Abuelita")
BehavioralCancer 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: With Love, Grandma ("Con Cariño, Abuelita") GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Time frame
Up to 3 months2
Percent of modules completed by survivor-daughter dyads (acceptability)
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
Time frame
Up to 3 monthsSecondary outcomes
1
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.
Time frame
Baseline, Up to 3 months2
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).
Time frame
Baseline, Up to 3 months3
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
Time frame
Baseline, Up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami Sylvester Comprehensive Cancer Center
Lead sponsor
The V Foundation for Cancer Research
Collaborator
Source ClinicalTrials.gov