NCT06409065 Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
| NCT ID | NCT06409065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2028-07-01 |
Trial Parameters
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Brief Summary
The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients' and their family caregivers' psychological wellbeing and overall quality of life.
Eligibility Criteria
Inclusion Criteria: * Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer * Be without disease progression for at least 3 months based on surveillance CT imaging * Have an ECOG performance status of ≤2 * Have a family caregiver willing to participate Both patient and caregiver must meet all the following criteria: * Be ≥18 years old * Be able to read and speak English or Spanish. * Be able to provide informed consent Additionally, either the patient and/or caregiver must: • Have a NCCN Distress Thermometer score of ≥4 Exclusion Criteria: A patient who meets the following criteria will be excluded from participation in this study: • Have cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist 3.3 Vulnerable Populations This study is designed for individuals who are at least 18 years of age, and there is no upper age limit. Children under the age of 18 will not
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