RECRUITING

Cocooned Moms Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Cocooned Moms Study is a pre- and post-design study primarily aimed at reducing stress, depressive symptoms, and blood pressure among expectant Black women by providing them with free access to the InovCares mobile app. InovCares is a culturally-sensitive telehealth platform designed for community-based care coordination in maternal care. It also offers a culturally tailored maternal mental health program, which provides access to resources addressing social determinants of health, cognitive behavioral therapy (CBT), interpersonal therapy, and compassion-focused therapy (CFT), along with peer-to-peer support and gamification. The study will evaluate the impact of these interventions on reported stress levels, depressive symptoms, sleep quality, and blood pressure (BP) among Black pregnant women.

Official Title

Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care

Quick Facts

Study Start:2025-06-01
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06968650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Exclusion criteria
  2. 1. Psychosis diagnosis
  3. 2. Does not speak or understand English
  4. 3. Participants who are not pregnant
  5. 4. Non-Black
  6. 5. Significant vision impairment.

Contacts and Locations

Study Contact

Judite Blanc, PhD
CONTACT
3052437452
cocoonedstudy@miami.edu
Mohamed Kamara
CONTACT
(614) 749-4256
mkamara@inovcares.com

Study Locations (Sites)

University Of Miami
Miami, Florida, 33136
United States
Dr.Traci's House
Tampa, Florida, 33604
United States

Collaborators and Investigators

Sponsor: InovCares Connected Comprehensive Healthcare Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Stress
  • Depression
  • Pregnancy
  • Blood Pressure