PCRC Best Supportive Care (PCRC BSC)

NCT02396641 | Completed

• 1 other identifier: Pro00060650
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Feasibility of Best Supportive Care Delivery

Keywords

Best Supportive Care

Outcome Measures

Primary Outcomes (1)

• Feasibility of thorough documentation of BSC delivery, consistent with BSC consensus statements, via the BSC checklist

  60 days

Study Arms (1)

Single Study Arm

EXPERIMENTAL

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

Interventions

Best Supportive Care Checklist OTHER

Single Study Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (4)

• Nipp RD, Currow DC, Cherny NI, Strasser F, Abernethy AP, Zafar SY. Best supportive care in clinical trials: review of the inconsistency in control arm design. Br J Cancer. 2015 Jun 30;113(1):6-11. doi: 10.1038/bjc.2015.192. Epub 2015 Jun 11.

  PMID: 26068397 RESULT

• Cherny NI, Abernethy AP, Strasser F, Sapir R, Currow D, Zafar SY. Improving the methodologic and ethical validity of best supportive care studies in oncology: lessons from a systematic review. J Clin Oncol. 2009 Nov 10;27(32):5476-86. doi: 10.1200/JCO.2009.21.9592. Epub 2009 Jun 29.

  PMID: 19564538 RESULT

• Zafar SY, Currow DC, Cherny N, Strasser F, Fowler R, Abernethy AP. Consensus-based standards for best supportive care in clinical trials in advanced cancer. Lancet Oncol. 2012 Feb;13(2):e77-82. doi: 10.1016/S1470-2045(11)70215-7.

  PMID: 22300862 RESULT

• Currow DC, Foley K, Zafar SY, Wheeler JL, Abernethy AP. The need for a re-evaluation of best supportive care studies reported to date. Br J Cancer. 2011 Feb 1;104(3):390-1. doi: 10.1038/sj.bjc.6606081. No abstract available.

  PMID: 21285970 RESULT

Study Design

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

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 2, 2020

Record last verified: 2015-12