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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-01-09 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 be included. First and foremost, it is unlikely that a minor is diagnosed with a metastatic solid tumor. It is also unlikely that a minor serves as the primary family caregiver of a patient with cancer. Additionally, the intervention is designed for adults, and the assessment tools are not validated for minors. While pregnant caregivers (self-identified) are study eligible, we will also exclude pregnant patients (medical notes). 3.4 Recruitment/Screening Process Eligible study participants (i.e. cancer patients) will be identified using the electronic clinic appointment systems on their tumor characteristics (i.e. cancer type and stage) and date of birth (i.e. minimum 18 years old). Potential patients and caregivers will be approached during patients' appointment at an outpatient oncology appointment, screened for eligibility, and consented. Since this is a family-based intervention, it is possible that caregivers will not be present during the patients' clinic visits. If so, patients will be asked for permission to contact the caregiver via phone to obtain consent.
Contact & Investigator
Kathrin Milbury, MD,PHD
PRINCIPAL INVESTIGATOR
MD Anderson
Frequently Asked Questions
Who can join the NCT06409065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06409065 currently recruiting?
Yes, NCT06409065 is actively recruiting participants. Contact the research team at kmilbury@mdanderson.org for enrollment information.
Where is the NCT06409065 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06409065 clinical trial?
NCT06409065 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Kathrin Milbury, MD,PHD at MD Anderson. The trial plans to enroll 400 participants.
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