The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family. The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers. The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment. The team can make referrals to other specialists. Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination. Secondary Objective(s): 1\. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care. Exploratory: 1. To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care. 2. To compare caregiver burden and quality of life between the study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
132
Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
Supportive care for the patient and caregiver will be provided by the treating oncologist.
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Average total MSAS score
Assessment of patient burden
Time frame: Up to 6 months
Average total FACT-G score
Measure patient quality of life
Time frame: Up to 6 months
Reason for study discontinuation (Patient reported outcome)
Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
Time frame: Up to 6 months
Duration on Study
Measure of central tendency of the duration patients were on the phase I study. Duration on study will serve as the primary objective for sample size determination
Time frame: Up to 6 months
Adverse events
Measure of central tendency of adverse events. AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities). The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed. An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE \* GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event. These scores will be compared between study arms
Time frame: Up to 6 months
Mean number of hours of palliative care services
Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency
Time frame: Up to 6 months
Type of palliative care services
Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency
Time frame: Up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.