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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06323291
Enrollment
20
Registered
2024-03-21
Start date
2024-04-01
Completion date
2025-05-26
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreas, Pancreatic Cancer, Caregiver

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.

Interventions

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.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER
Canopy Cancer Collective
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment RateUp to 12 MonthsMeasured by ≥ 50% of eligible participants recruited.
Participant Acceptance of the Digital Health Coaching ProgramUp to 12 WeeksMeasured by ≥ 70% of participant rating of the intervention as satisfactory. 4 item scale (score range 0-20) will be utilized.
Participant Ease of Usability of the Digital Health Coaching ProgramUp to 12 WeeksMeasured 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.
Feasibility of Utilizing the Digital Health Coaching ProgramUp to 12 WeeksMeasured by ≥ 70% of participant rating of being likely to utilize the intervention. 4 item scale (score range 0-20) will be utilized.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAmir Alishahi Tabriz, MD, PhD

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORPamela Hodul, MD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026