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Trial Title:
Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
NCT ID:
NCT06409065
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Meditation Program
Description:
Meditation and discussion sessions will be audio recorded
Arm group label:
Attention Control
Arm group label:
Behavioral Intervention (FFM Program)
Arm group label:
Usual Care
Other name:
Discussion Program
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kathrin Milbury, MD,PHD
Phone:
713-745-2868
Email:
kmilbury@mdanderson.org
Start date:
January 9, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06409065
http://www.mdanderson.org
