Stepped-Care Telehealth for Distress in Cancer Survivors
Telehealth
6 other identifiers
interventional
68
1 country
166
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Jul 2018
Longer than P75 for not_applicable anxiety
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2022
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedFebruary 27, 2026
February 1, 2026
4 years
January 31, 2017
July 19, 2023
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Feasibility of Study Intervention Measured by Retention
Study retention will be estimated by the number of participants who complete the Week 7 and 13 visits
Randomization through completion of study at week 13
Feasibility of Study Intervention Measured by Adherence to Intervention
Intervention adherence will be estimated as the mean proportion of therapy (high-intensity intervention) or check-in (low-intensity intervention) sessions each participant completes.
Randomization through completion of study at week 13
Feasibility of Study Intervention Measured by Recruitment Rate
Recruitment rate will be determined by the number of eligible participants who met all eligibility criteria and percent who agreed to participate.
Screening through end of study at week 13
Feasibility of Study Intervention Measured by Accrual Rate
The accrual rate is determined by dividing the overall number of participants recruited in each arm by the total span of 38 months between the start of the first screening for enrollment and the time the study closed to accrual.
Start of study screening time to end of study accrual
Secondary Outcomes (8)
Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks
Screening or baseline (if >30 days since screening), Week 13
Longitudinal Changes in the Patient Health Questionnaire (PHQ-9) Score for Depression From Baseline to 13 Weeks
Screening or baseline (if >30 days since screening), Week 13
Number of Participants With Moderate of Severe Depression (PHQ-9) or Anxiety (GAD-7) at 13 Weeks
Week 13
Longitudinal Changes in the Insomnia Severity Index (ISI) From Baseline to 13 Weeks.
Baseline (Week 0), Week 13
Longitudinal Changes in the PROMIS Fatigue Scale From Baseline to 13 Weeks
Baseline (Week 0), Week 13
- +3 more secondary outcomes
Study Arms (3)
Moderate Anxiety/depression: Low Intensity Stepped care
EXPERIMENTALparticipants 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.
Severe Anxiety/depression: High Intensity Stepped Care
EXPERIMENTALParticipants 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.
Enhanced Usual Care Control (EUC)
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (166)
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Low Country Cancer Care Associates PC
Savannah, Georgia, 31405, United States
Summit Cancer Care-Candler
Savannah, Georgia, 31405, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
HaysMed University of Kansas Health System
Hays, Kansas, 67601, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Olathe Health Cancer Center
Olathe, Kansas, 66061, United States
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, 66762, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Truman Medical Centers
Kansas City, Missouri, 64108, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803, United States
AdventHealth Infusion Center Haywood
Clyde, North Carolina, 28721, United States
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792, United States
AdventHealth Infusion Center Weaverville
Weaverville, North Carolina, 28787, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford South University Medical Center
Fargo, North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina, 29307, United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, 37620, United States
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City, Tennessee, 37604, United States
Regional Cancer Center at Indian Path Community Hospital
Kingsport, Tennessee, 37660, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Wellmont Medical Associates-Bristol
Bristol, Virginia, 24201, United States
Sovah Health Martinsville
Martinsville, Virginia, 24115, United States
Southwest VA Regional Cancer Center
Norton, Virginia, 24273, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Saint Vincent Hospital Cancer Center at Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study didn't reach the recruitment goal due to slow accrual rates.
Results Point of Contact
- Title
- Dr. Emily Dressler
- Organization
- Wake Forest NCORP Research Base
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Danhauer, PhD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 23, 2017
Study Start
July 19, 2018
Primary Completion
July 29, 2022
Study Completion
July 29, 2022
Last Updated
February 27, 2026
Results First Posted
September 21, 2023
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share