PCRC Best Supportive Care (PCRC BSC) (PCRC BSC)

February 27, 2020 updated by: Duke University

Implementation of Consensus-based Standards for Best Supportive Care in a Clinical Trial: a Pilot Study

The primary objective of this study is to formalize the delivery of BSC in advanced cancer trials. The first aim (to develop expert-derived consensus statements regarding components of supportive care in cancer clinical trials) and the second aim (to compare the extent to which documentation of current supportive care delivery in trials compares to the consensus statements) have been completed. The final aim of this study is to test the feasibility of thorough documentation of BSC delivery. That work is proposed as the primary aim of this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many cancer clinical trials are designed to evaluate the benefits of experimental anticancer drugs against best supportive care (BSC); many drugs have been registered based on very modest survival advantages when compared with BSC.

Universally across these studies, however, BSC control arms have not been standardized across sites in the way that trialists strive to standardize other interventions in clinical trials; are not consistent with contemporary palliative care practice; are not based on the extensive best available evidence; and are not described in any detail in most cases and certainly not sufficient detail to reproduce in subsequent studies. When reporting of BSC in trials is incomplete, the resulting data have uncertain internal and external validity.

Such poorly defined interventions and variation between sites is unacceptable for other aspects of a clinical trial. Furthermore, a poorly delivered BSC arm might systematically overestimate the performance of the intervention arm(s) in the study leading to poor decision making by clinicians and funders. With mounting evidence that early use of supportive/palliative care can improve patient outcomes, incomplete delivery of BSC might deprive patients of considerable benefit, potentially in the setting of far less toxicity.

In line with the CONSORT statement on reporting of clinical trials, our proposed study would seek to generate consensus-based standards for BSC definition (allowing this to be updated as new evidence becomes available), operationalize and measure outcomes in a clinical trial setting. In doing so, we intend to demonstrate: 1) the feasibility of thorough documentation of BSC, its delivery and measurement in a clinical trial; and 2) improved quality of life over standardized BSC. Specifically in terms of PCEOL research objectives, this study will develop an intervention designed to mitigate adverse physical and psychological symptoms and outcomes that focus especially on the beginning of the end-of-life phase.

This will be a prospective, single arm before and after consecutive cohort study of oncologists and patients. Initially, individual and institutional best practice in terms of supportive/palliative care delivery will be recorded across all sites (control period). Two months into study initiation, patients will complete pre-intervention patient ESAS and PNPC-sv assessment to measure their baseline care experience. At that point, all sites will simultaneously switch to the behavioral modification intervention (BSC checklist; experimental period). From that time forward, documentation of supportive care delivery will be documented via the BSC checklist and medical record review. At month four, physician acceptability and patient experience will be evaluated.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have incurable cancer
  • A shortened life expectancy such that the treating clinician would not be surprised if the patient passed away within 6 months
  • Karnofsky score ≥50
  • Must be receiving anticancer therapy (including chemotherapy or hormonal therapy)
  • By their clinician's best estimate, must be expected to receive at least two months of palliative anticancer therapy at the time of enrollment
  • Must be under active management for cancer- or treatment-related symptoms.

Exclusion Criteria:

  • Non-English speaking
  • Unable to read or write
  • Unable to travel to clinic for an appointment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Study Arm
This study arm consists of providers who will identify their baseline in Best Supportive Care, then have the intervention of using a Best Supportive Care checklist.
Other: Best Supportive Care Checklist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of thorough documentation of BSC delivery, consistent with BSC consensus statements, via the BSC checklist
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of Colorado, Denver
Northwestern University
University of California, San Francisco
American Cancer Society, Inc.
Agency for Healthcare Research and Quality (AHRQ)
Palliative Care Research Cooperative Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00060650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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