Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers

Recruiting now · Not applicable

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT06409065

Run by

M.D. Anderson Cancer Center

People needed

400

Starts

2024-01-09

Expected to finish

2028-08-31

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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).
• 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.

Where it is running

• MD Anderson — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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