Supportive care programs for advanced cancer patients and their caregivers
Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
This study is testing two supportive care programs delivered online to see if they can help improve the mental wellbeing and quality of life for people with advanced cancer and their family caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06409065 on ClinicalTrials.gov |
What this trial studies
This behavioral research focuses on the effects of two supportive care programs aimed at improving the psychological wellbeing and quality of life for patients with advanced cancer and their family caregivers. The interventions will be delivered via videoconferencing to enhance accessibility and scalability, allowing for a diverse patient population to participate. The study will recruit participants from multiple sites and will be conducted in both English and Spanish to ensure inclusivity. Eligible participants must have a specific cancer diagnosis and a family caregiver willing to engage in the program.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with metastatic cancer who have a family caregiver and are experiencing psychological distress.
Not a fit: Patients with cognitive deficits that hinder their ability to complete self-report instruments will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and quality of life for both cancer patients and their caregivers.
How similar studies have performed: Previous studies have shown positive outcomes with supportive care interventions for cancer patients, suggesting a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- MD Anderson — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kathrin Milbury, MD,PHD — MD Anderson
- Study coordinator: Kathrin Milbury, MD,PHD
- Email: kmilbury@mdanderson.org
- Phone: (713) 745-2868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.