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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02543541
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Structured palliative care Behavioral: Standard supportive care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
Study Start Date : October 25, 2015
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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.




Primary Outcome Measures :
  1. Average total MSAS score [ Time Frame: Up to 6 months ]
    Assessment of patient burden

  2. Average total FACT-G score [ Time Frame: Up to 6 months ]
    Measure patient quality of life

  3. Reason for study discontinuation (Patient reported outcome) [ Time Frame: Up to 6 months ]
    Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed

  4. Duration on Study [ Time Frame: Up to 6 months ]
    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

  5. Adverse events [ Time Frame: Up to 6 months ]
    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


Secondary Outcome Measures :
  1. Mean number of hours of palliative care services [ Time Frame: Up to 6 months ]
    Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency

  2. Type of palliative care services [ Time Frame: Up to 6 months ]
    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


Other Outcome Measures:
  1. Frequency of adverse events of patients receiving structured and usual supportive care [ Time Frame: Up to 6 months ]
  2. Average days on study [ Time Frame: Up to 6 months ]
  3. Change in FACT-G score [ Time Frame: From baseline to last contact, up to 6 months ]
    Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care

  4. Change in MSAS score [ Time Frame: From baseline to last contact, up to 6 months ]
    Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care

  5. Change in CRA score [ Time Frame: From baseline to last contact, up to 6 months ]
    Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care

  6. Change in QOLLTI-F score [ Time Frame: From baseline to last contact, up to 6 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543541


Locations
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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Michelle Treasure, MD Metrohealth Medical Center and Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02543541    
Other Study ID Numbers: CASE5Y15
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Case Comprehensive Cancer Center:
Palliative Care
Supportive Care
Caregiver
Phase I