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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543541
• Other study ID #: CASE5Y15
• Status: Completed
• Phase: N/A
• Start date: October 25, 2015
• Est. completion date: January 10, 2019

Study information

• Verified date: April 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• Standard supportive care
Supportive care for the patient and caregiver will be provided by the treating oncologist.

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of adverse events of patients receiving structured and usual supportive care		Up to 6 months
Other	Average days on study		Up to 6 months
Other	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
Other	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
Other	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
Other	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
Primary	Average total MSAS score	Assessment of patient burden	Up to 6 months
Primary	Average total FACT-G score	Measure patient quality of life	Up to 6 months
Primary	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
Primary	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
Primary	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	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
Secondary	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