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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. To compare caregiver burden and quality of life between the study arms.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Structured palliative care
* Behavioral: Standard supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Supportive Care<br> | Behavioral: Standard supportive care<br>* Supportive care for the patient and caregiver will be provided by the treating oncologist.<br>|
| Experimental: Structured Supportive Care<br> | Behavioral: Structured palliative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total MSAS score | Assessment of patient burden | Up to 6 months | 
| Average total FACT-G score | Measure patient quality of life | 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 | 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 | 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 | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Supportive Care, Caregiver, Phase I