Clinical trial NCT02543541: A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
Official title: A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Palliative Care
Supportive Care
Caregiver
Phase I
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average total MSAS score
timeFrame: Up to 6 months
measure: Average total FACT-G score
timeFrame: Up to 6 months
measure: Reason for study discontinuation (Patient reported outcome)
timeFrame: Up to 6 months
measure: Duration on Study
timeFrame: Up to 6 months
measure: Adverse events
timeFrame: Up to 6 months
Secondary outcomes:
measure: Mean number of hours of palliative care services
timeFrame: Up to 6 months
measure: Type of palliative care services
timeFrame: Up to 6 months
Other outcomes:
measure: Frequency of adverse events of patients receiving structured and usual supportive care
timeFrame: Up to 6 months
measure: Average days on study
timeFrame: Up to 6 months
measure: Change in FACT-G score
timeFrame: From baseline to last contact, up to 6 months
measure: Change in MSAS score
timeFrame: From baseline to last contact, up to 6 months
measure: Change in CRA score
timeFrame: From baseline to last contact, up to 6 months
measure: Change in QOLLTI-F score
timeFrame: From baseline to last contact, up to 6 months
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Metrohealth Medical Center and Case Comprehensive Cancer Center
name: Michelle Treasure, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.