Feasibility of Best Supportive Care DeliveryPCRC BSCNCT02396641
PCRC Best Supportive Care (PCRC BSC)
A study of Feasibility of Best Supportive Care Delivery, run by Duke University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feasibility of Best Supportive Care Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-English speaking
- Unable to read or write
- Unable to travel to clinic for an appointment
About this study
Official title: 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.
Read the 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.
- Being tested
- Best Supportive Care Checklist
- Keywords
- Best Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Supportive Care ChecklistOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Supportive Care Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of thorough documentation of BSC delivery, consistent with BSC consensus statements, via the BSC checklist
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Feasibility of Best Supportive Care DeliveryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Palliative Care Research Cooperative Group, Agency for Healthcare Research and Quality (AHRQ), American Cancer Society, Inc., University of California, San Francisco, Northwestern University, University of Colorado, Denver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396641
- Sponsor's protocol ID
- Pro00060650
- Acronym
- PCRC BSC
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2015
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26068397Cherny 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.
PubMed 19564538Zafar 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.
PubMed 22300862Currow 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.
PubMed 21285970
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Consensus-based Standards for Best Supportive Care in a Clinical Trial: a Pilot Study
- ClinicalTrials.gov ID
- NCT02396641
- Acronym / sponsor ID
- PCRC BSC / Pro00060650
- Keywords
- Best Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Palliative Care Research Cooperative Group, Agency for Healthcare Research and Quality (AHRQ), American Cancer Society, Inc., University of California, San Francisco, Northwestern University, University of Colorado, Denver
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Study Arm | Experimental | Other: Best Supportive Care ChecklistThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Non-English speaking
- Unable to read or write
- Unable to travel to clinic for an appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Supportive Care Checklist | Other | Single Study Arm |
Primary outcome
Feasibility of thorough documentation of BSC delivery, consistent with BSC consensus statements, via the BSC checklist
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Results publication: PubMed 26068397Nipp 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.
- Results publication: PubMed 19564538Cherny 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.
- Results publication: PubMed 22300862Zafar 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.
- Results publication: PubMed 21285970Currow 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Feasibility of Best Supportive Care Delivery, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of thorough documentation of BSC delivery, consistent with BSC consensus statements, via the BSC checklist (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396641, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.