Status:
COMPLETED
NextSteps Intervention for Advanced Cancer Patients and Caregivers
Lead Sponsor:
Baylor College of Medicine
Conditions:
Lung Cancer
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, pr...
Detailed Description
In this study, 200 advanced cancer patients who are within one month of treatment initiation (baseline) and their caregivers will complete baseline surveys and be randomized to NextSTEPS or a usual me...
Eligibility Criteria
Inclusion
- Patient has stage 3A, 3B, or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation OR patient has Stage 4 GI cancer and is within one month of treatment initiation
- patient is spending more than 50% of time out of bed on a daily basis as measured by an ECOG Performance Status rating of level 0, 1, or 2
- patient has stable brain metastases and no limitation on hepatic or renal function
- patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
- patient and caregiver are age 18 years or older
- patient and caregiver have the ability to read and understand English at a sixth grade level, as determined by ability to understand the consent form
- patient and caregiver can provide informed consent
Exclusion
- patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
- patient is currently enrolled in hospice.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04885439
Start Date
July 1 2015
End Date
June 30 2021
Last Update
April 22 2024
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030