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

Launched by M.D. ANDERSON CANCER CENTER · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how two different support programs can help improve the emotional wellbeing and overall quality of life for patients with advanced cancer and their family caregivers. The study aims to understand how these programs can help both the patient and the person caring for them feel better and manage the challenges that come with cancer.

To participate, patients must be at least 18 years old, have a specific type of advanced cancer (like metastatic breast or lung cancer), and have a family member or friend who is willing to join the study as a caregiver. They also need to have shown no signs of disease progression for at least three months and be able to communicate in English or Spanish. Participants can expect to engage in supportive activities designed to help both them and their caregivers cope better during this difficult time. It's important to note that this trial is currently recruiting, so eligible patients and caregivers can sign up to take part in this meaningful research.

Gender

ALL

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.