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OpenTrials
Completed

NCT Number: NCT06323291

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: Up to 12 Months

    Measured by ≥ 50% of eligible participants recruited.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Canopy Cancer Collective

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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