Stepped-Care Telehealth for Distress in Cancer Survivors

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03060096
Collaborator
National Cancer Institute (NCI) (NIH)
68
166
3
50.4
0.4
0

Study Details

Study Description

Brief Summary

Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.

Condition or Disease Intervention/Treatment Phase
  • Other: Severe Anxiety/depression: High Intensity Stepped Care
  • Other: Moderate Anxiety/depression: Low Intensity Stepped care
  • Other: Enhanced Usual Care Control
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be stratified by baseline score ≥15 on the GAD-7 and/or on the PHQ-9, indicating severe significant anxiety or depressive symptom. Participants with moderate symptoms only (10-14 on the PHQ-9 and/or 8-14 on the GAD-7) will be block randomized to either the low-intensity stepped care or to the enhanced usual care (EUC control). Participants with moderate to severe symptoms will be block randomized to either the high-intensity stepped care intervention or the EUC control. Block sizes will be chosen randomly to ensure that future assignments cannot be inferred from previous ones.Participants will be stratified by baseline score ≥15 on the GAD-7 and/or on the PHQ-9, indicating severe significant anxiety or depressive symptom. Participants with moderate symptoms only (10-14 on the PHQ-9 and/or 8-14 on the GAD-7) will be block randomized to either the low-intensity stepped care or to the enhanced usual care (EUC control). Participants with moderate to severe symptoms will be block randomized to either the high-intensity stepped care intervention or the EUC control. Block sizes will be chosen randomly to ensure that future assignments cannot be inferred from previous ones.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Stepped-Care Telehealth for Distress in Cancer Survivors
Actual Study Start Date :
Jul 19, 2018
Actual Primary Completion Date :
Jul 29, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Moderate Anxiety/depression: Low Intensity Stepped care

participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support.

Other: Moderate Anxiety/depression: Low Intensity Stepped care
The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.

Experimental: Severe Anxiety/depression: High Intensity Stepped Care

Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally.

Other: Severe Anxiety/depression: High Intensity Stepped Care
The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.

Active Comparator: Enhanced Usual Care Control (EUC)

Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety & depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study.

Other: Enhanced Usual Care Control
Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of study intervention measured by recruitment rate [Screening through end of study at week 13]

    Recruitment rate will be determined by the number of eligible participants who met all eligibility criteria and percent who agreed to participate.

  2. Feasibility of study intervention measured by accrual rate [Screening through end of study at week 13]

    Accrual rates will be calculated by calculating the mean number of participants recruited per month.

  3. Feasibility of study intervention measured by adherence to intervention [Randomization through completion of study at week 13]

    Intervention adherence will be estimated as the mean percentage of therapy (high-intensity intervention) or check-in (low-intensity intervention) sessions each participant completes.

  4. Feasibility of study intervention measured by retention [Randomization through completion of study at week 13]

    Study retention will be estimated by the proportion of participants who complete the Week 7 and 13 visits

Secondary Outcome Measures

  1. Longitudinal changes in the Generalized Anxiety Disorder-7 (GAD-7) score for anxiety [Screening, baseline (if >30 days since screening), Week 7, Week 13]

    The GAD-7 is a self-report measure of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of Generalized Anxiety Disorder (GAD). Longitudinal changes in the GAD-7 will be measured in participants to evaluate the effectiveness of the intervention in reducing anxiety. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. GAD-7 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe anxiety, respectively.

  2. Longitudinal changes in the Patient Health Questionnaire (PHQ-9) score for depression [Screening, baseline (if >30 days since screening), Week 7, Week 13]

    The PHQ-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder where participants rate how often they experienced 9 symptoms over past 2 weeks. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Longitudinal changes in the PHQ-9 will be measured in participants to evaluate the effectiveness of the intervention in reducing depression.

  3. Combined analysis of PHQ-9 and GAD-7 [Screening, baseline (if >30 days since screening), Week 7, Week 13]

    A combined variable will be created that indicates if a participant had moderate/severe depression or anxiety at mid- or post-intervention. Each stepped care group will be compared with EUC using a generalized estimating equation (GEE) approach with a logit link to determine if rates of the combined outcome differ at mid- or post-intervention.

  4. Longitudinal changes in the Insomnia Severity Index (ISI) [Baseline (Week 0), Week 13]

    The Insomnia Severity Index is a 7-item self-reported measure of type and severity of insomnia symptoms. Patients select 1 of 5 numbers with "0" indicating no problem, to "4" indicating very severe problem. ISI scores of 0-7 = no clinically significant insomnia; 8-14 =subthreshold insomnia; 15-21 clinical insomnia of moderate severity; 21-28 =severe clinical insomnia. Longitudinal changes in the ISI will be measured in participants to evaluate the effectiveness of the intervention on problems with sleep.

  5. Longitudinal changes in the PROMIS Fatigue Scale [Baseline (Week 0), Week 13]

    The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form is a measure of the experience of fatigue and the impact of fatigue on activities across multiple domains. Each questions has five response options ranging in value from one to five with one indicating the least amount of frequency/intensity and five indicating the highest frequency/intensity. Longitudinal changes in the PROMIS Fatigue Short Form will be measured in participants to evaluate the effectiveness of the intervention on problems with fatigue.

  6. Longitudinal changes in the Fear of Recurrence Inventory Severity Subscale [Baseline (Week 0), Week 13]

    The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence of cancer. Items are rated on a 5-point scale, where 0 = never/not at all, 1 = rarely/a little, 2 = sometimes/somewhat, 3 = most of the time/a lot and 4 = all the time/a great deal. Longitudinal changes in the FCRI scores will be measured in participants to evaluate the effectiveness of the intervention on fear of cancer recurrence.

  7. Longitudinal changes in the Health Status Questionnaire (SF-36) [Baseline (Week 0), Week 13]

    The Health Status Questionnaire (SF-36) is a self-report measure of quality of life. The 36 item questionnaire is divided into 8 subscales and 2 composite domains. Each of the 8 summed scores is linearly transformed onto a scale. The higher the score, the higher the quality of life. Longitudinal changes in the IES-R scores will be measured in participants to evaluate the effectiveness of the intervention on cancer-specific distress.

  8. Determine costs associated with stepped care mental health and enhanced usual care [Cornell Services Index baseline and week 13, weekly sessions logs (weeks 1-12), tracking log (Baseline to Week 13), implementation cost interviews at study completion]

    Includes costs of intervention implementation & health care costs for each participant. Implementation costs determined using data on time spent on intervention activities (tracking logs,staff interviews). Other costs (e.g., telephone, printed materials) valued using project records on expenses. All costs summed related to each intervention to obtain total cost of implementing. Total costs in each arm will be divided by # of patients served to obtain average cost/patient. Sensitivity analyses conducted to assess how implementation costs vary depending on inputs used, such as salaries. Health care cost determined using data from self-reported utilization of heath care services (Cornell Services Index). To calculate these costs, published data on avg costs of these events or data from sources (such as Medicare Fee Schedule, Medical Expenditure Panel Survey) will be used. Analyses conducted to examine impact of interventions on health care utilization and costs. Use of linear models with

  9. Analysis of differential effects of intervention measured by subgroup stratification [Screening, Baseline (Week 0), Mid week 7, Week 13]

    Stratified subgroup analysis of secondary outcomes by gender, age, race/ethnicity, stratification arm(moderate/severe), expectancy and psychotropic medication use at baseline.

  10. Longitudinal changes in the Impact of Events Scale-Revised (IES-R) [Baseline (Week 0), Week 13]

    The IES-R is a 22-item self-report measure of cancer-specific distress. Patients select numbers from 0 (not at all) to 4 (extremely) to indicate how frequently particular comments have been true during the past seven days. The total score, which ranges from 0 to 88 provides a measure of the severity of distress. Longitudinal changes in the IES-R scores will be measured in participants to evaluate the effectiveness of the intervention on cancer-specific distress.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥18 years

  • Score ≥10 on the GAD-7 and/or a score ≥8 on the PHQ-9, indicating clinically significant anxiety or depressive symptoms, respectively.

  • Past history of treated Stage I, II, or III (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (to include uterine and cervical) cancers and non-Hodgkin's lymphoma.

  • 6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer. Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on maintenance or hormonal therapies.

  • Participant resides in California, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, Tennessee, or Wisconsin

  • Study-trained therapist in the state where the participant resides.

  • Must be able to speak and understand English.

  • Must have access to a telephone

Exclusion Criteria:
  • Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days prior to randomization].

  • Self-reported active alcohol or substance abuse within the last 30 days.

  • Past history of prostate cancer or non-Hodgkin's lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy).

  • Diagnosis of a second malignancy (except for non-melanoma skin cancers) after a previous diagnosis of breast, colorectal, gynecologic cancers and non-Hodgkin's lymphoma

  • Progressive cancer (must be considered no evidence of disease or stable)

  • Self -reported history of a diagnosis of dementia from a healthcare provider.

  • Self -reported psychotic symptoms in the last 30 days prior to randomization

  • Active suicidal ideation (currently reported suicidal plan and intent).

  • Any change in psychotropic medications within the last 30 days.

  • Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff)

  • Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
2 Kaiser Permanente-Fresno Fresno California United States 93720
3 Kaiser Permanente-Modesto Modesto California United States 95356
4 Kaiser Permanente-South Sacramento Sacramento California United States 95823
5 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
6 Kaiser San Rafael-Gallinas San Rafael California United States 94903
7 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
8 Kaiser Permanente-Stockton Stockton California United States 95210
9 Augusta University Medical Center Augusta Georgia United States 30912
10 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
11 Low Country Cancer Care Associates PC Savannah Georgia United States 31405
12 Summit Cancer Care-Candler Savannah Georgia United States 31405
13 Rush - Copley Medical Center Aurora Illinois United States 60504
14 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
15 Illinois CancerCare-Canton Canton Illinois United States 61520
16 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
17 SIH Cancer Institute Carterville Illinois United States 62918
18 Illinois CancerCare-Carthage Carthage Illinois United States 62321
19 Centralia Oncology Clinic Centralia Illinois United States 62801
20 Carle on Vermilion Danville Illinois United States 61832
21 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
22 Decatur Memorial Hospital Decatur Illinois United States 62526
23 Illinois CancerCare-Dixon Dixon Illinois United States 61021
24 Carle Physician Group-Effingham Effingham Illinois United States 62401
25 Crossroads Cancer Center Effingham Illinois United States 62401
26 Illinois CancerCare-Eureka Eureka Illinois United States 61530
27 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
28 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
29 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
30 Illinois CancerCare-Macomb Macomb Illinois United States 61455
31 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
32 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
33 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
34 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
35 Illinois CancerCare-Pekin Pekin Illinois United States 61554
36 Illinois CancerCare-Peoria Peoria Illinois United States 61615
37 Methodist Medical Center of Illinois Peoria Illinois United States 61636
38 Illinois CancerCare-Peru Peru Illinois United States 61354
39 Valley Radiation Oncology Peru Illinois United States 61354
40 Illinois CancerCare-Princeton Princeton Illinois United States 61356
41 Southern Illinois University School of Medicine Springfield Illinois United States 62702
42 Springfield Clinic Springfield Illinois United States 62702
43 Memorial Medical Center Springfield Illinois United States 62781
44 Carle Cancer Center Urbana Illinois United States 61801
45 The Carle Foundation Hospital Urbana Illinois United States 61801
46 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
47 HaysMed University of Kansas Health System Hays Kansas United States 67601
48 Lawrence Memorial Hospital Lawrence Kansas United States 66044
49 Olathe Health Cancer Center Olathe Kansas United States 66061
50 Ascension Via Christi - Pittsburg Pittsburg Kansas United States 66762
51 Salina Regional Health Center Salina Kansas United States 67401
52 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
53 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
54 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
55 Fairview Ridges Hospital Burnsville Minnesota United States 55337
56 Cambridge Medical Center Cambridge Minnesota United States 55008
57 Mercy Hospital Coon Rapids Minnesota United States 55433
58 Fairview Southdale Hospital Edina Minnesota United States 55435
59 Unity Hospital Fridley Minnesota United States 55432
60 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
61 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
62 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
63 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
64 Hennepin County Medical Center Minneapolis Minnesota United States 55415
65 Health Partners Inc Minneapolis Minnesota United States 55454
66 Monticello Cancer Center Monticello Minnesota United States 55362
67 New Ulm Medical Center New Ulm Minnesota United States 56073
68 Fairview Northland Medical Center Princeton Minnesota United States 55371
69 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
70 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
71 United Hospital Saint Paul Minnesota United States 55102
72 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
73 Lakeview Hospital Stillwater Minnesota United States 55082
74 Sanford Thief River Falls Medical Center Thief River Falls Minnesota United States 56701
75 Ridgeview Medical Center Waconia Minnesota United States 55387
76 Rice Memorial Hospital Willmar Minnesota United States 56201
77 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
78 Sanford Cancer Center Worthington Worthington Minnesota United States 56187
79 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
80 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
81 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
82 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
83 Cox Cancer Center Branson Branson Missouri United States 65616
84 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
85 Southeast Cancer Center Cape Girardeau Missouri United States 63703
86 Parkland Health Center - Farmington Farmington Missouri United States 63640
87 Capital Region Southwest Campus Jefferson City Missouri United States 65109
88 Freeman Health System Joplin Missouri United States 64804
89 Mercy Hospital Joplin Joplin Missouri United States 64804
90 Truman Medical Centers Kansas City Missouri United States 64108
91 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
92 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
93 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
94 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
95 Mercy Hospital South Saint Louis Missouri United States 63128
96 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
97 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
98 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
99 Mercy Hospital Springfield Springfield Missouri United States 65804
100 CoxHealth South Hospital Springfield Missouri United States 65807
101 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
102 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
103 Mercy Hospital Washington Washington Missouri United States 63090
104 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
105 AdventHealth Infusion Center Asheville Asheville North Carolina United States 28803
106 AdventHealth Infusion Center Haywood Clyde North Carolina United States 28721
107 AdventHealth Hendersonville Hendersonville North Carolina United States 28792
108 AdventHealth Infusion Center Weaverville Weaverville North Carolina United States 28787
109 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
110 Sanford South University Medical Center Fargo North Dakota United States 58103
111 Sanford Broadway Medical Center Fargo North Dakota United States 58122
112 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
113 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
114 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
115 Prisma Health Cancer Institute - Laurens Clinton South Carolina United States 29325
116 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
117 McLeod Regional Medical Center Florence South Carolina United States 29506
118 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
119 Tidelands Georgetown Memorial Hospital Georgetown South Carolina United States 29440
120 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
121 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
122 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
123 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
124 Self Regional Healthcare Greenwood South Carolina United States 29646
125 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
126 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
127 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
128 Spartanburg Medical Center Spartanburg South Carolina United States 29303
129 Spartanburg Medical Center - Mary Black Campus Spartanburg South Carolina United States 29307
130 MGC Hematology Oncology-Union Union South Carolina United States 29379
131 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
132 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
133 Wellmont Bristol Regional Medical Center Bristol Tennessee United States 37620
134 Wellmont Medical Associates Oncology and Hematology-Johnson City Johnson City Tennessee United States 37604
135 Regional Cancer Center at Indian Path Community Hospital Kingsport Tennessee United States 37660
136 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
137 Wellmont Medical Associates-Bristol Bristol Virginia United States 24201
138 Sovah Health Martinsville Martinsville Virginia United States 24115
139 Southwest VA Regional Cancer Center Norton Virginia United States 24273
140 Virginia Cancer Institute Richmond Virginia United States 23230
141 VCU Massey Cancer Center at Stony Point Richmond Virginia United States 23235
142 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
143 VCU Community Memorial Health Center South Hill Virginia United States 23970
144 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
145 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
146 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
147 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
148 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
149 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
150 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
151 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
152 Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin United States 54143
153 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
154 Aspirus Medford Hospital Medford Wisconsin United States 54451
155 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
156 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
157 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
158 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
159 HSHS Saint Nicholas Hospital Sheboygan Wisconsin United States 53081
160 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
161 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
162 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
163 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
164 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
165 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
166 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Suzanne Danhauer, PhD, Wake Forest Baptist Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03060096
Other Study ID Numbers:
  • IRB00047561
  • 1R21CA198237
  • 5R21CA198237-02
  • 3UG1CA189824-04S1
  • WF-30917CD
  • NCI-2017-01840
  • NCT03190291
First Posted:
Feb 23, 2017
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022