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

Early Phase 1

Active, not recruiting

• Conditions: Pancreatic Cancer
• Interventions: Behavioral: Coaching Sessions

• Registration Number: NCT06323291
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Study Start: 2024-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Health Coaching for Pancreatic Cancer Patients	Coaching Sessions	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.
Digital Health Coaching for Caregivers	Coaching Sessions	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.

Primary Outcome Measures

Name	Time	Method
Participant Ease of Usability of the Digital Health Coaching Program	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.
Recruitment Rate	Up to 12 Months	Measured by ≥ 50% of eligible participants recruited.
Feasibility of Utilizing the Digital Health Coaching Program	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.
Participant Acceptance of the Digital Health Coaching Program	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States