Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03780816
Other study ID # D18149
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2019
Est. completion date July 15, 2021

Study information

Verified date February 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 473
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation of provider-patient interactions and interviews
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.

Locations

Country Name City State
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2-week site observation period
Primary 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. 2-week site observation period
Primary 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. 2-week site observation period
Primary 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. 2-week site observation period
Primary 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. 2-week site observation period
Primary 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. 2-week site observation period
See also
  Status Clinical Trial Phase
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Recruiting NCT05045040 - Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03994601 - An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Completed NCT01393990 - A Study of LY2228820 in Participants With Advanced Cancer Phase 1
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Active, not recruiting NCT04121676 - Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer Phase 1
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03674567 - Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab Phase 1/Phase 2
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A
Completed NCT02778126 - A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer Phase 1
Completed NCT02529553 - A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Phase 1
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT02245204 - Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers Phase 1
Completed NCT01901237 - Yoga for Adolescent and Young Adult Non-Curative Cancer Patients N/A
Completed NCT01583777 - Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer Phase 1