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

April 11, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Pamela Hodul, MD
        • Contact:
        • Principal Investigator:
          • Kea Turner, MPH, PhD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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
  • Any participant that does not meet all inclusion criteria will be excluded.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Up to 12 Months
Measured by ≥ 50% of eligible participants recruited.
Up to 12 Months
Participant Acceptance of the Digital Health Coaching Program
Time Frame: Up to 12 Weeks
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
Time Frame: Up to 12 Weeks

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
Time Frame: Up to 12 Weeks

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

Collaborators and Investigators

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Canopy Cancer Collective

Investigators

  • Principal Investigator: Pamela Hodul, MD, Moffitt Cancer Center
  • Principal Investigator: Kea Turner, MPH, PhD, Moffitt Cancer Center

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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