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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323291
• Other study ID #: MCC-23077
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Emma Hume
• Phone: 813-745-6426
• Email: Emma.Hume[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Canopy Cancer Collective

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Measured by = 50% of eligible participants recruited.	Up to 12 Months
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials Website