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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06409065
• Other study ID #: 2023-0450
• Secondary ID: NCI-2024-03804
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: February 1, 2030

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Kathrin Milbury, MD,PHD
• Phone: (713) 745-2868
• Email: kmilbury[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To enhance the accessibility and scalability for future research, both the interventions (FFM and AC) will be delivered via videoconferencing. To increase the generalizability of the findings, a multi-site enrollment recruitment strategy will be used to enroll a diverse (including underserved) patient population. The program will be delivered in both English and Spanish and a varied social economic population will be enrolled in the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 1, 2030
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Meditation Program
Meditation and discussion sessions will be audio recorded

Locations

Country	Name	City	State
United States	MD Anderson	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms	Participants will complete the Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item self-report measure focusing on the affective component of depression, which is appropriate as patients may experience somatic symptoms due to treatment toxicities rather than depression.	Through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center Website