Cancer Coaching And Remote Education For Self-Empowerment (CARES) Study

Study Overview

Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study

This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.

N/A

Pancreatic Cancer

BEHAVIORAL: Coaching Sessions

MCC-23077

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	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-16
First Submitted that Met QC Criteria 2024-03-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-18
First Posted (ACTUAL) 2024-03-21	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Health Services Research

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Digital Health Coaching for Pancreatic Cancer Patients Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment.	BEHAVIORAL: Coaching Sessions Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email dep
OTHER: Digital Health Coaching for Caregivers Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment.	BEHAVIORAL: Coaching Sessions Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email dep

Participant Group/Arm

Intervention/Treatment

OTHER: Digital Health Coaching for Pancreatic Cancer Patients

Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment.

BEHAVIORAL: Coaching Sessions

Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email dep

OTHER: Digital Health Coaching for Caregivers

Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment.

BEHAVIORAL: Coaching Sessions

Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email dep

Primary Outcome Measures	Measure Description	Time Frame
Recruitment Rate	Measured by ≥ 50% of eligible participants recruited.	Up to 12 Months
Participant Acceptance of the Digital Health Coaching Program	Measured by ≥ 70% of participant rating of the intervention as satisfactory. 4 item scale (score range 0-20) will be utilized.	Up to 12 Weeks
Participant Ease of Usability of the Digital Health Coaching Program	Measured by ≥ 70% of participant rating the mobile application as easy-to-use for scheduling coaching visits. 4 item scale (score range 0-20) will be utilized.	Up to 12 Weeks
Feasibility of Utilizing the Digital Health Coaching Program	Measured by ≥ 70% of participant rating of being likely to utilize the intervention. 4 item scale (score range 0-20) will be utilized.	Up to 12 Weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

18 years of age or older.
Participant must have a pancreatic cancer diagnosis or be a caregiver such as a friend or spouse.
Participant must be planning to receive treatment and/or care management at Moffitt Cancer Center.
Participant must be able to speak and read English.
Participant must be able to provide informed consent.

Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia
Any participant that does not meet all inclusion criteria will be excluded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Canopy Cancer Collective

Investigators

PRINCIPAL_INVESTIGATOR: Amir Alishahi Tabriz, MD, PhD, Moffitt Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record