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

NCT02543541 | Completed DMC

• 1 other identifier: CASE5Y15
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Palliative Care; Supportive Care; Caregiver; Phase I

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Mean number of hours of palliative care services

  Up to 6 months

• Type of palliative care services

  Up to 6 months

Other Outcomes (6)

• 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

  From baseline to last contact, up to 6 months

Study Arms (2)

Standard Supportive Care

ACTIVE COMPARATOR

Behavioral: Standard supportive care

Structured Supportive Care

EXPERIMENTAL

Behavioral: Structured palliative care

Interventions

Structured palliative care BEHAVIORAL

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.

Structured Supportive Care

Standard supportive care BEHAVIORAL

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

Standard Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with a hematologic malignancy.
• 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.
• Caregivers who are solely professional, paid caregivers

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 34033228 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michelle Treasure, MD

  Metrohealth Medical Center and Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 7, 2015
• Study Start: October 25, 2015
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

US (1)