- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06323291
Cancer Coaching and Remote Education for Self-Empowerment (CARES) Studie
This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Tampa, Florida, Forente stater, 33612
- Moffitt Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Digital Health Coaching for Pancreatic Cancer Patients
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. |
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. |
|
Annen: Digital Health Coaching for Caregivers
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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment Rate
Tidsramme: Up to 12 Months
|
Measured by ≥ 50% of eligible participants recruited. |
Up to 12 Months
|
|
Participant Acceptance of the Digital Health Coaching Program
Tidsramme: 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. |
Up to 12 Weeks
|
|
Participant Ease of Usability of the Digital Health Coaching Program
Tidsramme: 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. |
Up to 12 Weeks
|
|
Feasibility of Utilizing the Digital Health Coaching Program
Tidsramme: 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. |
Up to 12 Weeks
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Pamela Hodul, MD, Moffitt Cancer Center
- Hovedetterforsker: Amir Alishahi Tabriz, MD, PhD, Moffitt Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MCC-23077
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