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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Standard supportive care; Behavioral: Structured palliative care

Detailed Description

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
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events of patients receiving structured and usual supportive care		Up to 6 months
Average days on study		Up to 6 months
Change in FACT-G score	Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care	From baseline to last contact, up to 6 months
Change in MSAS score	Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care	From baseline to last contact, up to 6 months
Change in CRA score	Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care	From baseline to last contact, up to 6 months
Change in QOLLTI-F score	Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care	From baseline to last contact, up to 6 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Michelle Treasure, MD, Metrohealth Medical Center and Case Comprehensive Cancer Center

Publications and helpful links

General Publications

• Treasure M, Daly B, Cao S, Fu P, Hong A, Weinstein E, Surdam J, Meropol NJ, Dowlati A. A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials. Cancer Med. 2021 Jul;10(13):4312-4321. doi: 10.1002/cam4.3971. Epub 2021 May 25.

Study record dates

Study Major Dates

• Study Start: October 25, 2015
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Caregiver; Palliative Care; Supportive Care; Phase I
• Other Study ID Numbers: CASE5Y15