A Study to Evaluate A Resilient Living Program for Patients with Advancer Cancer and Their Caregivers
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-011510
NCT ID: NCT04480008
Sponsor Protocol Number: 19-011510
About this study
The primary purpose of this study is to determine feasibility as measured by consent of at least 25% of eligible patients and their caregivers (defined as those who met with the study coordinator), adherence (75% of the enrolled participants will complete at least 3 of the 4 Resilient Living sessions), and acceptability (measured by ) of the delivery of the Resilient Living intervention to patients with advanced cancer and their caregivers.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - Patients:
- Age ≥ 18 years old.
- English fluency.
- No diagnosed severe cognitive impairment.
- Diagnosis of advanced, incurable solid tumor cancer.
- Expected prognosis > 6 months.
- Provide informed consent (written or electronic).
- Ability to complete questionnaire(s) by themselves or with assistance.
- Patient baseline distress score ≥ 4/10 OR identified as having distress that would benefit from program by care team or provider.
- Ability to do first Resilient Living session in person.
Inclusion Criteria - Caregivers:
- Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study.
- Provide informed consent (written or electronic).
- Ability to complete questionnaire(s) by themselves or with assistance.
- Age ≥ 18 years old.
- English fluency.
- No diagnosed severe cognitive impairment.
- Ability to do first Resilient Living session in person.
Exclusion Criteria:
- As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
- Other psychological co-morbidities such as untreated schizophrenia, bipolar disease.
- Participated in the Mayo Clinic study entitled “Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals with Advanced Cancer Undergoing Outpatient Chemotherapy."
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Deirdre Pachman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available