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Implementation and Effectiveness Trial of HN-STAR (HN-STAR)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HN-STAR Intervention
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancer focused on measuring Survivorship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Survivor Inclusion Criteria:

  • Age ≥18 years.
  • Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, any part of pharynx and unknown squamous cell carcinoma primary.
  • Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
  • Deemed free of disease at last assessment.
  • Cognitively and physically able to complete study survey per local NCORP site staff discretion.
  • Scheduled for a clinic visit with a provider who has agreed to participate in this study and meets requirements for the arm to which their practice has been assigned (the practice designated clinician) for routine follow-up.
  • Willing to complete study assessments 3, 6, and 9 months after the designated clinic visit either 1) remotely (via smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.

Survivor Exclusion Criteria:

  • In active cancer treatment (including hormone therapy) for any other cancer, excluding local therapy for non-melanoma skin cancer.
  • Evidence of prior cancer (excluding non-melanoma skin cancer) within 3 years of the designated clinician visit.
  • Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
  • Recurrent, persistent, or progressive disease at last assessment (per scan or clinical assessment).
  • Does not speak or read English, because the HN-STAR tool is only available in English at this time.
  • Received only surgery as treatment for head and neck cancer.
  • Current, planned enrollment, or in follow-up on another interventional symptom management study protocol, as per patient self-report or research staff members' knowledge at the time of consent. Concurrent participation in treatment or imaging studies is allowed.

Designated Clinician Inclusion Criteria:

  • Age > = 18 years
  • MD, DO, NP, or PA
  • Able to speak and read English, because the HN-STAR tool is only available in English at this time.
  • Routinely provides care for cancer patients or survivors.
  • Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit

Stakeholders Inclusion Criteria:

  • Age > = 18
  • Member of the practice clinical or administrative team who is involved in the oversight of the delivery of head and neck cancer survivorship care or who would make decisions about implementing head and neck survivorship tools such as HN-STAR. This could include clinic administrators, nurse navigators, key clinical team members, program directors, information technology specialists, and other staff (e.g., service line or nursing leaders).
  • Employed for at least one month at the practice.
  • Able to speak and reads English, because the HN-STAR tool is only available in English at this time.

Stakeholder Exclusion Criteria:

  • Is the designated clinician at the practice.

Primary Care Provider Inclusion Criteria:

  • Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
  • Age >= 18
  • MD, DO, NP, or PA

Primary Care Provider Exclusion Criteria:

  • Provides Oncology Care

Sites / Locations

  • Kingman Regional Medical CenterRecruiting
  • Rocky Mountain Cancer Centers - BoulderRecruiting
  • Beebe South Coastal Health CampusRecruiting
  • Beebe Health CampusRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Augusta University Medical CenterRecruiting
  • Queen's Medical CenterRecruiting
  • Carle on VermilionRecruiting
  • Decatur Memorial HospitalRecruiting
  • Carle Physician Group-Mattoon/CharlestonRecruiting
  • Carle Cancer CenterRecruiting
  • Reid HealthRecruiting
  • Iowa Methodist Medical CenterRecruiting
  • Mercy Medical Center - Des MoinesRecruiting
  • Harold Alfond Center for Cancer CareRecruiting
  • Maine Medical Partners OtolaryngologyRecruiting
  • Maine Medical Partners - South PortlandRecruiting
  • Park Nicollet Clinic - Saint Louis ParkRecruiting
  • Regions HospitalRecruiting
  • OptumCare Cancer Care at Seven HillsRecruiting
  • OptumCare Cancer Care at CharlestonRecruiting
  • OptumCare Cancer Care at Fort ApacheRecruiting
  • Montefiore Medical Center-Einstein CampusRecruiting
  • Montefiore Medical Center - Moses CampusRecruiting
  • Sanford Roger Maris Cancer CenterRecruiting
  • Licking Memorial HospitalRecruiting
  • Geisinger Medical CenterRecruiting
  • AnMed Health Cancer CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • Saint Francis HospitalRecruiting
  • Prisma Health Cancer Institute - ButternutRecruiting
  • Prisma Health Cancer Institute - FarisRecruiting
  • Saint Francis Cancer CenterRecruiting
  • Spartanburg Medical CenterRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • Bon Secours Saint Francis Medical CenterRecruiting
  • ThedaCare Regional Cancer CenterRecruiting
  • Saint Vincent Hospital Cancer Center Green BayRecruiting
  • Aspirus Cancer Care - James Beck Cancer CenterRecruiting
  • Aspirus Cancer Care - Stevens PointRecruiting
  • Aspirus Regional Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

HN-STAR

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Change in HNC-Specific QOL
Measured using Trial Outcome Index from the Functional Assessment of Cancer Therapy Head and Neck. It is a 23-item summary measure that ranges from 0 to a maximum of 96 where higher scores indicate better overall physical and functional outcomes.

Secondary Outcome Measures

Change in QoL
Measured using domains and overall measures from the FACT H&N. The total score evaluates overall QoL in Head and Neck Cancer patients and ranges from 0 to 144, with higher scores indicating better overall QoL. Subscales are calculated by summing the relevant questions [answered using a Likert scale ranging from 0 (Not at all) to 4 (Very much)]. Higher scores on subscales represent a better health state.
Change in QoL
Measured using scales from the EORTC QLQ-C30. Scales from the EORTC QLQ-C30 evaluate functional status, global health status and symptoms. All scales range from 0 to 100, with higher scores representing higher functioning, QoL or symptoms.
Change symptom burden
Measured using scales from the EORTC QLQ-HN43. Symptom subscales from the EORTC QLQ- HN43 range from 0 to 100, with higher scores representing higher symptom burden.
Change in symptom burden
Measured using PRO-CTCAE items for relevant symptoms.
Change in pain
Measured using Brief Pain Inventory Short Form. Pain severity and interference items are measured using a scale from 0 to 10, with higher scores indicating worse pain or interference. The average is used as a summary measure of pain severity and pain interference.
Change in patient activation
Measured using Patient Activation Measure Short Form. PAM score ranges from 0 to 100, with higher score meaning higher level of activation.
Change in perceived quality of cancer care
Measured using the CAHPS® Cancer Care Survey.
Adherence and surveillance of guideline concordant care
Rate at which survivors had ≥1 visit to a primary care provider in the year following the initial visit will be compared by arm. Receipt or non-receipt of guideline-concordant cancer surveillance will be derived from the oncology medical records and compared by arm.

Full Information

First Posted
December 4, 2019
Last Updated
October 3, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04208490
Brief Title
Implementation and Effectiveness Trial of HN-STAR
Acronym
HN-STAR
Official Title
Implementation and Effectiveness Trial of HN-STAR
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
People who have been treated for head and neck cancer (HNC survivors) can experience serious consequences from their cancer and its treatment, ongoing risks of new cancers, and other unrelated illnesses. These concerns pose challenges to the provision of comprehensive care to HNC survivors. We created HN-STAR to facilitate and tailor the ongoing care of HNC survivors. Survivors use HN-STAR on a computer or tablet to answer questions about symptoms and health concerns before a routine visit with a cancer care provider. During the clinic visit, the provider uses HN-STAR to see evidence-based recommendations for managing each concern reported by the survivor. The provider and survivor discuss recommendations and select appropriate actions (e.g., testing, referrals, prescriptions, self-management). HN-STAR produces a survivorship care plan that includes all reported concerns and the actions selected in clinic. The survivorship care plan is given to the survivor and the primary care provider. Three months, six months, and nine months later, the survivor uses HN-STAR from home (or clinic) to report their concerns again, and a new survivorship care plan is created each time. Our trial randomizes 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 recent survivors of head and neck cancer. We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes (including cancer-related well-being, symptoms, and patient activation) over one year compared to survivors in the usual care arm, measured by surveys at baseline and one year later. We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm. Our final aim investigates the implementation of HN-STAR in clinical practice, using interviews and surveys of survivors, providers, and other clinic staff to understand the feasibility, acceptability, appropriateness, and other aspects of providing survivorship care to head and neck cancer survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Survivorship

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HN-STAR
Arm Type
Other
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
HN-STAR Intervention
Intervention Description
The Head and Neck Survivorship Tool (HN-STAR) is a web-based tool used to assist clinicians in implementing the ACS/ASCO HNC survivorship guidelines.
Primary Outcome Measure Information:
Title
Change in HNC-Specific QOL
Description
Measured using Trial Outcome Index from the Functional Assessment of Cancer Therapy Head and Neck. It is a 23-item summary measure that ranges from 0 to a maximum of 96 where higher scores indicate better overall physical and functional outcomes.
Time Frame
Baseline & 1 year
Secondary Outcome Measure Information:
Title
Change in QoL
Description
Measured using domains and overall measures from the FACT H&N. The total score evaluates overall QoL in Head and Neck Cancer patients and ranges from 0 to 144, with higher scores indicating better overall QoL. Subscales are calculated by summing the relevant questions [answered using a Likert scale ranging from 0 (Not at all) to 4 (Very much)]. Higher scores on subscales represent a better health state.
Time Frame
Baseline & 1 year
Title
Change in QoL
Description
Measured using scales from the EORTC QLQ-C30. Scales from the EORTC QLQ-C30 evaluate functional status, global health status and symptoms. All scales range from 0 to 100, with higher scores representing higher functioning, QoL or symptoms.
Time Frame
Baseline & 1 year
Title
Change symptom burden
Description
Measured using scales from the EORTC QLQ-HN43. Symptom subscales from the EORTC QLQ- HN43 range from 0 to 100, with higher scores representing higher symptom burden.
Time Frame
Baseline & 1 year
Title
Change in symptom burden
Description
Measured using PRO-CTCAE items for relevant symptoms.
Time Frame
Baseline & 1 year
Title
Change in pain
Description
Measured using Brief Pain Inventory Short Form. Pain severity and interference items are measured using a scale from 0 to 10, with higher scores indicating worse pain or interference. The average is used as a summary measure of pain severity and pain interference.
Time Frame
Baseline & 1 year
Title
Change in patient activation
Description
Measured using Patient Activation Measure Short Form. PAM score ranges from 0 to 100, with higher score meaning higher level of activation.
Time Frame
Baseline & 1 year
Title
Change in perceived quality of cancer care
Description
Measured using the CAHPS® Cancer Care Survey.
Time Frame
Baseline & 1 year
Title
Adherence and surveillance of guideline concordant care
Description
Rate at which survivors had ≥1 visit to a primary care provider in the year following the initial visit will be compared by arm. Receipt or non-receipt of guideline-concordant cancer surveillance will be derived from the oncology medical records and compared by arm.
Time Frame
These variables will be derived from the medical record during the year following the initial visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Survivor Inclusion Criteria: Age ≥18 years. Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary. Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit. Deemed free of disease at last assessment. Cognitively and physically able to complete study survey per local NCORP site staff discretion. Scheduled for a clinic visit with a provider who has agreed to participate in this study and meets requirements for the arm to which their practice has been assigned (the practice designated clinician) for routine follow-up. Willing to complete study assessments 3, 6, and 9 months after the designated clinic visit either 1) remotely (via telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer. Survivor Exclusion Criteria: In active cancer treatment (including hormone therapy) for any other cancer, excluding local therapy for non-melanoma skin cancer. Evidence of prior cancer (excluding non-melanoma skin cancer) within 3 years of the designated clinician visit. Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma. Recurrent, persistent, or progressive disease at last assessment (per scan or clinical assessment). Does not speak or read English, because the HN-STAR tool is only available in English at this time. Received only surgery as treatment for head and neck cancer. Current, planned enrollment, or in follow-up on another interventional symptom management study protocol, as per patient self-report or research staff members' knowledge at the time of consent. Concurrent participation in treatment or imaging studies is allowed. Designated Clinician Inclusion Criteria: Age > = 18 years MD, DO, NP, or PA Able to speak and read English, because the HN-STAR tool is only available in English at this time. Routinely provides care for cancer patients or survivors. Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit Stakeholders Inclusion Criteria: Age > = 18 Member of the practice clinical or administrative team who is involved in the oversight of the delivery of head and neck cancer survivorship care or who would make decisions about implementing head and neck survivorship tools such as HN-STAR. This could include clinic administrators, nurse navigators, key clinical team members, program directors, and other staff (e.g., service line or nursing leaders). Employed for at least one month at the practice. Able to speak and reads English, because the HN-STAR tool is only available in English at this time. Stakeholder Exclusion Criteria: Is the designated clinician at the practice. Primary Care Provider Inclusion Criteria: Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study. Age >= 18 MD, DO, NP, or PA Primary Care Provider Exclusion Criteria: Provides Oncology Care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Craver
Phone
336-716-0891
Email
NCORP@wakehealth.edu
Facility Information:
Facility Name
Kingman Regional Medical Center
City
Kingman
State/Province
Arizona
ZIP/Postal Code
86401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A Ellerton
Facility Name
Rocky Mountain Cancer Centers - Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A Masters
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A Masters
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-444-2223
First Name & Middle Initial & Last Name & Degree
Marcus S Noel
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-444-2223
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
706-721-2388
Email
ga_cares@augusta.edu
First Name & Middle Initial & Last Name & Degree
Dr. Sharad A Ghamande
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
808-545-8548
First Name & Middle Initial & Last Name & Degree
Christa Braun-Inglis
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Tanmay Sahai
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4740
Email
rhamrick@dmhhs.org
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Tanmay Sahai
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Tanmay Sahai
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Howard M Gross
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
515-241-6727
First Name & Middle Initial & Last Name & Degree
Joshua Luckenbill
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
308-398-6518
Email
clinicaltrials@sfmc-gi.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Harold Alfond Center for Cancer Care
City
Augusta
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-626-4855
First Name & Middle Initial & Last Name & Degree
Vatche Tchekmedyian
Facility Name
Maine Medical Partners Otolaryngology
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-8670
Email
ClinicalResearch@mmc.org
First Name & Middle Initial & Last Name & Degree
Vatche Tchekmedyian
Facility Name
Maine Medical Partners - South Portland
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-8670
Email
ClinicalResearch@mmc.org
First Name & Middle Initial & Last Name & Degree
Vatche Tchekmedyian
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Pamala A. Pawloski
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Pamala A. Pawloski
Facility Name
OptumCare Cancer Care at Seven Hills
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-384-0013
Email
research@sncrf.org
Facility Name
OptumCare Cancer Care at Charleston
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-384-0013
Email
research@sncrf.org
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-384-0013
Email
research@sncrf.org
Facility Name
Montefiore Medical Center-Einstein Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
718-379-6866
Email
eskwak@montefiore.org
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
718-379-6866
Email
eskwak@montefiore.org
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-234-6161
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Preston D. Steen
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
740-348-4000
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D Moore
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Sorab Gupta
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-512-4651
Email
rhonda.ballew@anmedhealth.org
First Name & Middle Initial & Last Name & Degree
Leander Cannick
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-792-9321
Email
hcc-clinical-trials@musc.edu
First Name & Middle Initial & Last Name & Degree
Evan M. Graboyes
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-603-6213
Email
melissa_beckman@bshsi.org
First Name & Middle Initial & Last Name & Degree
Robert D. Siegel
Facility Name
Prisma Health Cancer Institute - Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
864-241-6251
First Name & Middle Initial & Last Name & Degree
Ki Young Chung
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-522-2066
Email
kim.williams3@prismahealth.org
First Name & Middle Initial & Last Name & Degree
Jeffrey K. Giguere
Facility Name
Saint Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-603-6213
Email
melissa_beckman@bshsi.org
First Name & Middle Initial & Last Name & Degree
Robert D. Siegel
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-560-6104
Email
kmertz-rivera@gibbscc.org
First Name & Middle Initial & Last Name & Degree
Amarinthia (Amy) Curtis
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicalTrialsSF@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Preston D. Steen
Facility Name
Bon Secours Saint Francis Medical Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
804-893-8663
Email
Jaime_scott@bshsi.org
First Name & Middle Initial & Last Name & Degree
William J. Irvin
Facility Name
ThedaCare Regional Cancer Center
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Harsha V. Poola
Facility Name
Saint Vincent Hospital Cancer Center Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
920-433-8889
Email
ewd_research_admin@hshs.org
First Name & Middle Initial & Last Name & Degree
Anthony J Jaslowski
Facility Name
Aspirus Cancer Care - James Beck Cancer Center
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
715-847-2353
Email
Beth.Knetter@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J Huang
Facility Name
Aspirus Cancer Care - Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
715-847-2353
Email
Beth.Knetter@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J Huang
Facility Name
Aspirus Regional Cancer Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
877-405-6866
First Name & Middle Initial & Last Name & Degree
Andrew J Huang

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
IPD Sharing Time Frame
6 months after publication for a 2 year duration
IPD Sharing Access Criteria
upon request to NCORP@wakehealth.edu
IPD Sharing URL
https://nctn-data-archive.nci.nih.gov/

Learn more about this trial

Implementation and Effectiveness Trial of HN-STAR

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