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

NCT06323291 | Completed Early Phase 1

• 1 other identifier: MCC-23077
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

Pancreas; Pancreatic Cancer; Caregiver

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Digital Health Coaching for Pancreatic Cancer Patients

OTHER

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

Digital Health Coaching for Caregivers

OTHER

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

Interventions

Coaching Sessions 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; Digital Health Coaching for Pancreatic Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Canopy Cancer Collective: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Amir Alishahi Tabriz, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Pamela Hodul, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: April 1, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)