- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01629069
A Transplant or Cancer Resilience Intervention
A Resilience Intervention Involving Mindfulness Training for Transplant and Cancer Patients and Their Caregivers
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Transplant medicine and cancer are major strategic foci of Mayo Clinic. At Mayo Clinic, we are often challenged to respond adequately to the high levels of stress encountered by our transplant patients and their care-givers. The overall aim of this project is to pilot a 6 session intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes. Demonstration of a feasible and effective program will allow us to offer similar programs at all three sites. This program has potential to better meet our transplant patients' needs, improve outcomes, and set us apart from other transplant programs who do not offer this intervention for patients and caregivers. Psychiatry already has a good collaboration with transplant medicine, with psychiatry screening transplant patients and following a large subset of patients. Many of the referrals to psychiatry post-transplant have to do with difficulty managing stress or break-down in care-giver support. The proposed program would address this unmet need with a more comprehensive intervention than is currently available at the Mayo Clinic. The role of this pilot program is to:
- Explore the feasibility of routinely offering a resilience intervention involving mindfulness based stress reduction to our solid organ and stem-cell transplant and cancer patients and their care-givers.
- Pilot a mindfulness-based group treatment for stress reduction to assess its impact, using standardized rating tools, on transplant patient stress-levels, sleep quality, anxiety, depression, medical outcomes, and health-care utilization
- Examine patient and care-giver acceptance/adherence and satisfaction
- Understand the resources both in terms of staffing and fees required to offer this as a clinical program in the future
- Explore the reimbursement options for covering the program's expenses.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
Arizona
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic in Arizona
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient listed for liver, heart, kidney, or bone marrow transplant
- Patient who has received a liver, heart, kidney, or bone marrow transplant
- Caregiver of transplant patient
- patient with diagnosis of cancer, either active or in remission
- supportive care partner of cancer patient
Exclusion Criteria
- Suicidal
- Severe cognitive impairment
- psychotic
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Participant in MBRT
6 sessions of Mindfulness Based Resilience Training
|
6 weekly group sessions
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient questionaire
Tidsramme: baseline to 6 weeks
|
baseline to 6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 12-004988
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