Clinical trial NCT06409065: Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
Official title: Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

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.

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: MD Anderson
name: Kathrin Milbury, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: