Brief Summary
This study investigates cancer care delivery in adolescent and young adult patients with acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the patient level and seeking input from healthcare providers may help doctors increase rates of adherence to National Comprehensive Cancer Network (NCCN) treatment guidelines. It may also improve care for adolescent and young adult patients with acute lymphoblastic leukemia.
Brief Title
Cancer Care Delivery in Adolescent and Young Adult Patients With Acute Lymphoblastic Leukemia
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the proportion of adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients with a documented treatment plan consistent with NCCN guidelines for AYAs with ALL.
II. To evaluate the proportion of AYA ALL patients whose delivered treatment during induction and post-induction therapy (PIT) is consistent with NCCN guidelines for AYAs with ALL.
III. To determine the impact of treating physician specialty and facility type on likelihood of AYA ALL patients having a documented treatment plan concordant with NCCN guidelines when stratified by age group (15-17year\[y\], 18-21y, and 22-39y).
IV. To determine the impact of treating physician specialty and facility type on the likelihood of AYA ALL patients receiving induction and post-Induction therapy (PIT) concordant with NCCN guidelines when stratified by age group (15-17y, 18-21y, and 22-39y).
V. To identify for AYAs with ALL, targetable structure- and process-level barriers and facilitators which will increase the proportion of patients having a documented treatment plan and receiving treatment according to NCCN guidelines.
EXPLORATORY OBJECTIVE:
I. To explore potential correlations with clinical and social demographic variables to the presence of a documented treatment plan and delivered treatment consistent with NCCN guidelines in AYAs with ALL.
OUTLINE:
CHART REVIEW: Patient medical record data is abstracted and treatment plans are reviewed for consistency to NCCN guidelines. For each patient, induction and post-induction care is recorded as either concordant with NCCN guidelines or non-concordant with NCCN guidelines.
SITE QUESTIONNAIRE: Participating sites complete a questionnaire which is designed to capture facility-oriented data.
FOCUS GROUPS: Healthcare providers participate in focus groups over 2-3 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses which will be recorded on a flip-chart or white board, followed by discussion of the ideas for clarification.
I. To evaluate the proportion of adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients with a documented treatment plan consistent with NCCN guidelines for AYAs with ALL.
II. To evaluate the proportion of AYA ALL patients whose delivered treatment during induction and post-induction therapy (PIT) is consistent with NCCN guidelines for AYAs with ALL.
III. To determine the impact of treating physician specialty and facility type on likelihood of AYA ALL patients having a documented treatment plan concordant with NCCN guidelines when stratified by age group (15-17year\[y\], 18-21y, and 22-39y).
IV. To determine the impact of treating physician specialty and facility type on the likelihood of AYA ALL patients receiving induction and post-Induction therapy (PIT) concordant with NCCN guidelines when stratified by age group (15-17y, 18-21y, and 22-39y).
V. To identify for AYAs with ALL, targetable structure- and process-level barriers and facilitators which will increase the proportion of patients having a documented treatment plan and receiving treatment according to NCCN guidelines.
EXPLORATORY OBJECTIVE:
I. To explore potential correlations with clinical and social demographic variables to the presence of a documented treatment plan and delivered treatment consistent with NCCN guidelines in AYAs with ALL.
OUTLINE:
CHART REVIEW: Patient medical record data is abstracted and treatment plans are reviewed for consistency to NCCN guidelines. For each patient, induction and post-induction care is recorded as either concordant with NCCN guidelines or non-concordant with NCCN guidelines.
SITE QUESTIONNAIRE: Participating sites complete a questionnaire which is designed to capture facility-oriented data.
FOCUS GROUPS: Healthcare providers participate in focus groups over 2-3 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses which will be recorded on a flip-chart or white board, followed by discussion of the ideas for clarification.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
* Newly diagnosed with either Ph- or Ph+ ALL between January 1st, 2012 and December 31st, 2016
* Age at diagnosis: 15-39 years, inclusive
* Both diagnosed and initially treated at the participating National Cancer Institute Community Oncology Research Program (NCORP) institution during induction and post-induction therapy (PIT)
* Aim 3: Healthcare professional currently employed at a participating NCORP institution
* Eligible healthcare providers include but are not limited to: physicians, registered nurses (RNs), nurse practitioners, physician assistants, patient advocates, social workers, pharmacists and clinical research associates (CRAs)
* Aim 3: Direct involvement in the care of AYA ALL patients
Exclusion Criteria:
* Diagnosis of secondary ALL
* Diagnosis of mixed lineage acute leukemia
* Diagnosis of acute leukemia of ambiguous lineage (ALAL)
* Diagnosis of Burkitt's leukemia
* Transfer of care to another institution during induction or post-induction therapy (PIT)
* Aim 3: Trainee
* Newly diagnosed with either Ph- or Ph+ ALL between January 1st, 2012 and December 31st, 2016
* Age at diagnosis: 15-39 years, inclusive
* Both diagnosed and initially treated at the participating National Cancer Institute Community Oncology Research Program (NCORP) institution during induction and post-induction therapy (PIT)
* Aim 3: Healthcare professional currently employed at a participating NCORP institution
* Eligible healthcare providers include but are not limited to: physicians, registered nurses (RNs), nurse practitioners, physician assistants, patient advocates, social workers, pharmacists and clinical research associates (CRAs)
* Aim 3: Direct involvement in the care of AYA ALL patients
Exclusion Criteria:
* Diagnosis of secondary ALL
* Diagnosis of mixed lineage acute leukemia
* Diagnosis of acute leukemia of ambiguous lineage (ALAL)
* Diagnosis of Burkitt's leukemia
* Transfer of care to another institution during induction or post-induction therapy (PIT)
* Aim 3: Trainee
Inclusion Criteria
Inclusion Criteria:
* Newly diagnosed with either Ph- or Ph+ ALL between January 1st, 2012 and December 31st, 2016
* Age at diagnosis: 15-39 years, inclusive
* Both diagnosed and initially treated at the participating National Cancer Institute Community Oncology Research Program (NCORP) institution during induction and post-induction therapy (PIT)
* Aim 3: Healthcare professional currently employed at a participating NCORP institution
* Eligible healthcare providers include but are not limited to: physicians, registered nurses (RNs), nurse practitioners, physician assistants, patient advocates, social workers, pharmacists and clinical research associates (CRAs)
* Aim 3: Direct involvement in the care of AYA ALL patients
* Newly diagnosed with either Ph- or Ph+ ALL between January 1st, 2012 and December 31st, 2016
* Age at diagnosis: 15-39 years, inclusive
* Both diagnosed and initially treated at the participating National Cancer Institute Community Oncology Research Program (NCORP) institution during induction and post-induction therapy (PIT)
* Aim 3: Healthcare professional currently employed at a participating NCORP institution
* Eligible healthcare providers include but are not limited to: physicians, registered nurses (RNs), nurse practitioners, physician assistants, patient advocates, social workers, pharmacists and clinical research associates (CRAs)
* Aim 3: Direct involvement in the care of AYA ALL patients
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
39 Years
Minimum Age
15 Years
NCT Id
NCT03204916
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
ACCL16N1CD
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)
Primary Outcomes
Outcome Description
Primary analysis will describe the proportion of patients meeting this endpoint in overall evaluation window.
Outcome Measure
Proportion of patients with a documented treatment plan concordant with National Comprehensive Cancer Network (NCCN) guidelines for adolescent and young adults with acute lymphoblastic leukemia
Outcome Time Frame
Overall evaluation window, an average of 12 weeks after start of treatment
Outcome Description
Primary analysis will describe the proportion of patients meeting this endpoint in induction evaluation window.
Outcome Measure
Proportion of patients with a documented treatment plan concordant with National Comprehensive Cancer Network (NCCN) guidelines for adolescent and young adults with acute lymphoblastic leukemia
Outcome Time Frame
Induction evaluation window, an average of 4 weeks after start of treatment
Outcome Description
Primary analysis will describe the proportion of patients in post-induction therapy (PIT) evaluation window.
Outcome Measure
Proportion of patients with a documented treatment plan concordant with National Comprehensive Cancer Network (NCCN) guidelines for adolescent and young adults with acute lymphoblastic leukemia
Outcome Time Frame
PIT evaluation window, an average of 8 weeks after induction
Outcome Description
Primary analysis will describe the proportion of patients meeting this endpoint.
Outcome Measure
Proportion of patients whose delivered treatment in induction and two months of post-induction phase chemotherapy is consistent with National Comprehensive Cancer Network guidelines for adolescents and young adults with acute lymphoblastic leukemia
Outcome Time Frame
An average of 12 weeks after start of treatment
Outcome Description
Descriptive analysis will be used to examine the differences in the proportion of patients with a documented treatment plan consistent with the NCCN guidelines and with induction and post-induction therapy delivered according to guidelines, between primary physician type (pediatric oncology vs. other) and facility type groups (children's hospital \[CH\] vs. other).
Outcome Measure
Proportion of patients with a documented treatment plan consistent with the National Comprehensive Cancer Network guidelines based upon primary physician type (pediatric oncology versus other) and facility type groups (children's hospital versus other)
Outcome Time Frame
An average of 12 weeks after start of treatment
Outcome Description
Descriptive analysis will be used to examine the differences in the proportion of patients with a documented treatment plan consistent with the NCCN guidelines and with induction and post-induction therapy delivered according to guidelines, between primary physician type (pediatric oncology vs. other) and facility type groups (CH vs. other).
Outcome Measure
Proportion of patients with induction and post-induction therapy delivered consistent with the National Comprehensive Cancer Network guidelines based upon primary physician type and facility type groups
Outcome Time Frame
An average of 12 weeks after start of treatment
Outcome Description
These endpoints will be defined by the issues and language used by the participants during the focus groups. Will be descriptive in nature and employ thematic analysis.
Outcome Measure
Facilitators and barriers ranked by importance to National Comprehensive Cancer Network guidelines for adolescent and young adults with acute lymphoblastic leukemia
Outcome Time Frame
Up to 6 focus groups, assessed up to 4 years
Secondary Ids
Secondary Id
NCI-2017-01053
Secondary Id
ACCL16N1CD
Secondary Id
COG-ACCL16N1CD
Secondary Id
ACCL16N1CD
Secondary Id
UG1CA189955
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Healthcare professional currently employed at a participating NCORP institution, and patients diagnosed with Philadelphia chromosome (Ph) negative or positive ALL between January 1, 2012 and December 31, 2016.
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
39
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Loeb
Investigator Email
david.loeb@einsteinmed.org
Investigator Phone
718-741-2342
Categories Mesh Debug
Blood & Bone Marrow Cancers --- PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
Blood & Bone Marrow Cancers --- LEUKEMIA, LYMPHOID
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
LEUKEMIA, LYMPHOID
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES