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Trial Title:
Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study
NCT ID:
NCT06323291
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreas
Pancreatic Cancer
Caregiver
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Coaching Sessions
Description:
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.
Arm group label:
Digital Health Coaching for Caregivers
Arm group label:
Digital Health Coaching for Pancreatic Cancer Patients
Summary:
This Pilot Study will evaluate a 12-week pilot program that offers digital health
coaching for individuals with pancreatic cancer and their caregivers.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Hume
Phone:
813-745-6426
Email:
Emma.Hume@moffitt.org
Investigator:
Last name:
Kea Turner, MPH, PhD
Email:
Principal Investigator
Investigator:
Last name:
Pamela Hodul, MD
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
Canopy Cancer Collective
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323291
http://www.moffitt.org/clinical-trials-research/clinical-trials/