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

NCT ID: NCT06323291

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pancreas Pancreatic Cancer Caregiver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Coaching Sessions

Intervention Type BEHAVIORAL

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 depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions.

Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness.

Participants will receive content for each of the modules via email.

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.

Group Type OTHER

Coaching Sessions

Intervention Type BEHAVIORAL

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 depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions.

Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness.

Participants will receive content for each of the modules via email.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions.

Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness.

Participants will receive content for each of the modules via email.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canopy Cancer Collective

UNKNOWN

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amir Alishahi Tabriz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Pamela Hodul, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCC-23077

Identifier Type: -

Identifier Source: org_study_id