A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials

A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials

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.

Patient Inclusion Criteria:

• Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
• Patients are eligible to enroll on this study with or without the enrollment of their caregiver.

Patient Exclusion Criteria:

• Patients diagnosed with a hematologic malignancy.

Caregiver Inclusion Criteria:

• Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
• Caregivers must be willing to complete surveys at baseline and on monthly basis.

Caregiver Exclusion Criteria:

• Caregivers who are solely professional, paid caregivers