Advanced CancerNCT03780816
Variation in Cancer Centers' End-of-Life Quality
An observational study of Advanced Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a qualitative study of local organizational and provider practice norms, and how these norms influence patient and family expectations and provider decision-making heuristics for minority patients with advanced cancer at major US cancer centers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Observation of provider-patient interactions and interviews
- How many people
- 473 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 15 Jul 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient and inpatient oncology providers who meet inclusion criteria and are nominated by their practice managers will be observed. If providers do not opt out after being introduced to the study by cancer center leadership, providers will be contacted directly for recruitment. A sub-sample of observed providers will be invited to participate in semi-structured interviews. A sub-sample of all patients (and caregivers) cared for by the shadowed provider who meet inclusion criteria will be invited to participate in semi-structured interviews. Recruitment will seek equal numbers of minority and non-minority participants. Personnel involved in developing and enforcing organizational policies, procedures, and practices, will also be invited to participate in semi-structured interviews.
Provider Inclusion Criteria:
- Hospital-based providers (e.g., hospitalists, intensivists, emergency medicine, advanced practice providers) or oncology providers (e.g. medical oncologists, radiation oncologists, surgical oncologists, advanced practice providers)
- Care for patients with advanced cancer
- High clinical load
- Have high peer influence
Patient Inclusion Criteria:
- Advanced cancer
- Provider "would not be surprised" if patient died in the next 12 months
Caregiver Inclusion Criteria:
-Self-reported caregiver of a patient meeting inclusion criteria
Other Informant Inclusion Criteria:
- Member of the cancer center, hospital, unit, or service line leadership
Patient Exclusion Criteria:
- Potential medical malpractice cases
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
This is a qualitative study of local organizational and provider practice norms, and how these norms influence patient and family expectations and provider decision-making heuristics for minority patients with advanced cancer at major US cancer centers. Outpatient visits with oncologists will be observed and documented via hand-written field notes. Semi-structured interviews with selected participating clinicians, patients, caregivers, and other informants will follow the initial observation.
Read the detailed description
The purpose of this study is to identify organizational and provider practice norms at major US cancer centers, and how these norms influence patient and family expectations and provider decision-making heuristics for later-line chemotherapy, hospice, and ICU admission among minority patients with advanced cancer. Norms are rules about which there is at least some degree of consensus, enforced through social sanctions. Heuristics are unconscious judgments or rules of thumb.The study team will collect direct observation data from outpatient clinic visits, and semi-structured interview data from selected participating providers, patients, caregivers, and other informants following the initial observation.
The study team will perform 2-week, qualitative case studies of 3 theoretically sampled National Comprehensive Cancer Network (NCCN) and NCI Comprehensive Cancer Centers. Oncology practice managers' nominations of providers with particular cancer focuses, high volumes, and high peer influence will be used to sample oncologic clinicians to shadow in outpatient clinic settings. Observations will be hand-written during the clinic visit, and later dictated and transcribed. Observed providers will be invited to be interviewed. Select patients and caregivers will also be invited to be interviewed following initial clinic observation. Other informants will be invited to be interviewed on an ad hoc basis. All interviews will be audio recorded and transcribed, and interviews will be semi-structured to allow for natural flow of conversation. Observations and interviews will all be done by the study PI, project coordinator, and/or another research team member.
Clinical observations and semi-structured interviews will assess the following outcomes: 1) formal and informal organizational norms influencing provider decision-making, 2) provider decision-making heuristics, and 3) patient and caregiver expectations. All outcomes will be assessed regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral.
The investigators aim to to explore the how COVID-19 intersects with organizational and provider norms, practices, and service delivery for patients with advanced cancer.
- Conditions
- Advanced Cancer
- Being tested
- Observation of provider-patient interactions and interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of provider-patient interactions and interviewsOther
Clinical interactions between cancer patients and providers will be observed and hand-written field notes recorded and later transcribed. Semi-structured interviews with providers, patients, caregivers, and other informants will take place following initial observation.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Site: Norris Cotton Cancer Center | Observation and interview protocols will be piloted at this site. The content of these observations and interviews will not be analyzed for content. Receives: Other: Observation of provider-patient interactions and interviews | |
| Karmanos Cancer Institute | Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data. Receives: Other: Observation of provider-patient interactions and interviews | |
| UNC Lineberger Comprehensive Cancer Center | Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data. Receives: Other: Observation of provider-patient interactions and interviews | |
| UAB O'Neal Comprehensive Cancer Center | Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data. Receives: Other: Observation of provider-patient interactions and interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formal and informal norms influencing provider decision making as assessed using ethnographic observation
Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
Measured: 2-week site observation period
Provider decision making heuristics as assessed using ethnographic observation
Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
Measured: 2-week site observation period
Patient expectations as assessed using ethnographic observation
Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
Measured: 2-week site observation period
Formal and informal norms influencing provider decision making as assessed using semi-structured interviews
Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
Measured: 2-week site observation period
Provider decision making heuristics as assessed using semi-structured interviews
Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
Measured: 2-week site observation period
Patient expectations as assessed using semi-structured interviews
Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
Measured: 2-week site observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Jul 2019
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Amber Barnato, Dartmouth-Hitchcock Medical Center
- Investigators
- Amber E Barnato, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780816
- Sponsor's protocol ID
- D18149
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2018
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knutzen KE, Schifferdecker KE, Murray GF, Alam SS, Brooks GA, Kapadia NS, Butcher R, Barnato AE. Role of norms in variation in cancer centers' end-of-life quality: qualitative case study protocol. BMC Palliat Care. 2020 Aug 27;19(1):136. doi: 10.1186/s12904-020-00641-x.
PubMed 32854691
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Cancer Centers' End-of-Life Quality
- ClinicalTrials.gov ID
- NCT03780816
- Acronym / sponsor ID
- D18149
- Conditions
- Advanced Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
This is a qualitative study of local organizational and provider practice norms, and how these norms influence patient and family expectations and provider decision-making heuristics for minority patients with advanced cancer at major US cancer centers. Outpatient visits with oncologists will be observed and documented via hand-written field notes. Semi-structured interviews with selected participating clinicians, patients, caregivers, and other informants will follow the initial observation.
Detailed description
The purpose of this study is to identify organizational and provider practice norms at major US cancer centers, and how these norms influence patient and family expectations and provider decision-making heuristics for later-line chemotherapy, hospice, and ICU admission among minority patients with advanced cancer. Norms are rules about which there is at least some degree of consensus, enforced through social sanctions. Heuristics are unconscious judgments or rules of thumb.The study team will collect direct observation data from outpatient clinic visits, and semi-structured interview data from selected participating providers, patients, caregivers, and other informants following the initial observation.
The study team will perform 2-week, qualitative case studies of 3 theoretically sampled National Comprehensive Cancer Network (NCCN) and NCI Comprehensive Cancer Centers. Oncology practice managers' nominations of providers with particular cancer focuses, high volumes, and high peer influence will be used to sample oncologic clinicians to shadow in outpatient clinic settings. Observations will be hand-written during the clinic visit, and later dictated and transcribed. Observed providers will be invited to be interviewed. Select patients and caregivers will also be invited to be interviewed following initial clinic observation. Other informants will be invited to be interviewed on an ad hoc basis. All interviews will be audio recorded and transcribed, and interviews will be semi-structured to allow for natural flow of conversation. Observations and interviews will all be done by the study PI, project coordinator, and/or another research team member.
Clinical observations and semi-structured interviews will assess the following outcomes: 1) formal and informal organizational norms influencing provider decision-making, 2) provider decision-making heuristics, and 3) patient and caregiver expectations. All outcomes will be assessed regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral.
The investigators aim to to explore the how COVID-19 intersects with organizational and provider norms, practices, and service delivery for patients with advanced cancer.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilot Site: Norris Cotton Cancer Center | – | Other: Observation of provider-patient interactions and interviewsObservation and interview protocols will be piloted at this site. The content of these observations and interviews will not be analyzed for content. |
| Karmanos Cancer Institute | – | Other: Observation of provider-patient interactions and interviewsObservations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data. |
| UNC Lineberger Comprehensive Cancer Center | – | Other: Observation of provider-patient interactions and interviewsObservations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data. |
| UAB O'Neal Comprehensive Cancer Center | – | Other: Observation of provider-patient interactions and interviewsObservations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient and inpatient oncology providers who meet inclusion criteria and are nominated by their practice managers will be observed. If providers do not opt out after being introduced to the study by cancer center leadership, providers will be contacted directly for recruitment. A sub-sample of observed providers will be invited to participate in semi-structured interviews. A sub-sample of all patients (and caregivers) cared for by the shadowed provider who meet inclusion criteria will be invited to participate in semi-structured interviews. Recruitment will seek equal numbers of minority and non-minority participants. Personnel involved in developing and enforcing organizational policies, procedures, and practices, will also be invited to participate in semi-structured interviews.
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 |
|---|---|---|
| Observation of provider-patient interactions and interviewsClinical interactions between cancer patients and providers will be observed and hand-written field notes recorded and later transcribed. Semi-structured interviews with providers, patients, caregivers, and other informants will take place following initial observation. | Other | Karmanos Cancer Institute, Pilot Site: Norris Cotton Cancer Center, UAB O'Neal Comprehensive Cancer Center, UNC Lineberger Comprehensive Cancer Center |
Primary outcome
Formal and informal norms influencing provider decision making as assessed using ethnographic observation
Time frame: 2-week site observation period
Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
Provider decision making heuristics as assessed using ethnographic observation
Time frame: 2-week site observation period
Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
Patient expectations as assessed using ethnographic observation
Time frame: 2-week site observation period
Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
Formal and informal norms influencing provider decision making as assessed using semi-structured interviews
Time frame: 2-week site observation period
Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
Provider decision making heuristics as assessed using semi-structured interviews
Time frame: 2-week site observation period
Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
Patient expectations as assessed using semi-structured interviews
Time frame: 2-week site observation period
Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
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 16 Feb 2023.
- Derived from this study: PubMed 32854691Knutzen KE, Schifferdecker KE, Murray GF, Alam SS, Brooks GA, Kapadia NS, Butcher R, Barnato AE. Role of norms in variation in cancer centers' end-of-life quality: qualitative case study protocol. BMC Palliat Care. 2020 Aug 27;19(1):136. doi: 10.1186/s12904-020-00641-x.
- Individual participant dataSharing planned: No
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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.
Amber E Barnato, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Formal and informal norms influencing provider decision making as assessed using ethnographic observation (time frame: 2-week site observation period). The study lists 6 primary outcomes in all. 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 NCT03780816, which also lists 1 linked publication.
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 16 Feb 2023.