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AnxietyTelehealthNCT03060096

Stepped-Care Telehealth for Distress in Cancer Survivors

A study testing Severe Anxiety/depression: High Intensity Stepped Care and Moderate Anxiety/depression: Low Intensity Stepped care in people with Anxiety and Depressive Symptoms, run by Wake Forest University Health Sciences at 166 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Depressive Symptoms, Sleep Disturbance
What is being tested?
Severe Anxiety/depression: High Intensity Stepped Care and Moderate Anxiety/depression: Low Intensity Stepped care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
166 sitesUnited States
Study dates
19 Jul 2018to 29 Jul 2022
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

166 sites in 1 country.

166 sites in 1 country

United States166 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates-Bristol

    Bristol, Virginia, 24201

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Wellmont Medical Associates Oncology and Hematology-Johnson City

    Johnson City, Tennessee, 37604

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Regional Cancer Center at Indian Path Community Hospital

    Kingsport, Tennessee, 37660

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Marshfield Clinic - Ladysmith Center

    Ladysmith, Wisconsin, 54848

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Saint Vincent Hospital Cancer Center at Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Sovah Health Martinsville

    Martinsville, Virginia, 24115

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Olathe Health Cancer Center

    Olathe, Kansas, 66061

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Ascension Via Christi - Pittsburg

    Pittsburg, Kansas, 66762

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, 93401

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Low Country Cancer Care Associates PC

    Savannah, Georgia, 31405

  • Summit Cancer Care-Candler

    Savannah, Georgia, 31405

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • HSHS Saint Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • VCU Community Memorial Health Center

    South Hill, Virginia, 23970

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Spartanburg Medical Center - Mary Black Campus

    Spartanburg, South Carolina, 29307

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Marshfield Clinic Stevens Point Center

    Stevens Point, Wisconsin, 54482

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • AdventHealth Infusion Center Weaverville

    Weaverville, North Carolina, 28787

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

Other trials in United States

About this study

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.

Read the detailed description

Noting the need for evidence-based cancer survivorship care, the American Society of Clinical Oncology (ASCO) published guidelines for screening, assessment, and care of psychosocial distress (anxiety, depression) in adults with cancer. These guidelines recommend screening all adults with cancer for distress and treating those with moderate or severe symptoms using a stepped-care approach tailored to distress severity. While these guidelines apply to survivors with all cancer types across the cancer treatment and survivorship continuum, we have chosen to focus on survivors with non-metastatic breast, colorectal, prostate, uterine, and cervical cancers , as well as those with any stage lymphoma (Hodgkin's or non-Hodgkin's). Further, we have focused on the post-treatment survivorship period 6 months-5 years post-treatment because distress may be more likely to be assessed and addressed after treatment completion. A significant minority of post-treatment survivors is at risk for anxiety and depression symptoms during the five years following the end of treatment and accessible interventions are needed to treat them.

The purpose of this study is to test a method of implementing this stepped-care approach in community oncology practices caring for cancer survivors, using self-directed and stepped-care telehealth approaches based on cognitive-behavioral theory. Our approach is based on a previous trial of telephone-based cognitive behavioral therapy for rural older adults with Generalized Anxiety Disorder (NIMH 1R01MH083664: The Tranquil Moments Study; PI: Brenes), which has demonstrated high acceptability and efficacy for reducing anxiety, worry, and depressive symptoms in a rural geriatric population. This protocol adapts the methods of the previous trial to bring psychosocial care to underserved cancer survivors, many of whom have minimal or no access to mental health providers. Cancer survivors will be recruited through multiple NCI Community Oncology Research Program (NCORP) sites through the NCI-funded Wake Forest NCORP Research Base (WF NCORP RB).

We will obtain data on feasibility, outcome variability, and efficacy for designing a subsequent fully powered randomized controlled trial (RCT) assessing the effects of the intervention on distress in cancer survivors. In the planned larger study, we anticipate that this intervention will: (a) reduce treatment barriers for post-treatment cancer survivors; (b) enhance availability of psychosocial treatment (through use of telephone sessions and a workbook); and (c) result in reductions in anxiety and depressive symptoms in cancer survivors.

Being tested
Severe Anxiety/depression: High Intensity Stepped Care, Moderate Anxiety/depression: Low Intensity Stepped care, Enhanced Usual Care Control
Medical subject headings
Anxiety Disorders, Depression, Parasomnias, Recurrence, Fatigue, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Severe Anxiety/depression: High Intensity Stepped CareOther

    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.

  • Moderate Anxiety/depression: Low Intensity Stepped careOther

    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.

  • Enhanced Usual Care ControlOther

    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.

Study groups in NCT03060096
Study groupRoleWhat they receive
Moderate Anxiety/depression: Low Intensity Stepped careExperimentalparticipants 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.
Receives: Other: Moderate Anxiety/depression: Low Intensity Stepped care
Severe Anxiety/depression: High Intensity Stepped CareExperimentalParticipants 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.
Receives: Other: Severe Anxiety/depression: High Intensity Stepped Care
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.
Receives: Other: Enhanced Usual Care Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Randomization through completion of study at week 13

  2. 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.

    Measured: Randomization through completion of study at week 13

  3. 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.

    Measured: Screening through end of study at week 13

  4. 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.

    Measured: Start of study screening time to end of study accrual

Secondary outcomes (8)

  1. Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks

    The Generalized Anxiety Disorder (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. The first 7 questions are summed to create a total score ranging from 0 to 21. Higher scores reflect greater anxiety severity. Scores above 10 are considered to be in the clinical range. GAD-7 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe anxiety, respectively.

    Measured: Screening or baseline (if >30 days since screening), Week 13

  2. Longitudinal Changes in the Patient Health Questionnaire (PHQ-9) Score for Depression From Baseline to 13 Weeks

    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. Longitudinal changes in the PHQ-9 will be measured in participants to evaluate the effectiveness of the intervention in reducing depression. The possible range is 0-27. A larger score represents more severe depression level.

    Measured: Screening or baseline (if >30 days since screening), Week 13

  3. Number of Participants With Moderate of Severe Depression (PHQ-9) or Anxiety (GAD-7) at 13 Weeks

    A combined variable will be created that indicates if a participant had moderate/severe depression or anxiety at mid- or post-intervention. This is defined as either PHQ-9 or GAD-7 greater than or equal to 15.

    Measured: Week 13

  4. Longitudinal Changes in the Insomnia Severity Index (ISI) From Baseline to 13 Weeks.

    Measure Description: The Insomnia Severity Index (ISI) is 7-item self-report measure of type and severity of insomnia symptoms, including problems with sleep onset, sleep maintenance, or early morning awakening; satisfaction with current sleep pattern; interference with daily functioning; noticing impairment attributed to sleep problems; and level of concern or distress caused by the sleep problem. Each of the seven items is scored on a 5-point scale, ranging from 0 (lowest) to 4 (highest). The sum of the scores for all seven items yields a total score, which falls within a range of 0 to 28. A higher score indicates a greater level of sleep impairment.

    Measured: Baseline (Week 0), Week 13

  5. Longitudinal Changes in the PROMIS Fatigue Scale From Baseline to 13 Weeks

    The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a is a measure of the experience of fatigue and the impact of fatigue on activities across multiple domains. There are eight items rated on a scale of 1(never) to 5 (always) based on how often fatigue was experienced over the last 7 days. The sum of these eight items ranges from a minimum of 8 to a maximum of 40, with higher scores representing more fatigue. This total score is then converted into a t-score based on the PROMIS 8a adult conversion table. The smallest t score is 33.1 and the largest t score is 77.8. A higher t score indicates greater fatigue.

    Measured: Baseline (Week 0), Week 13

  6. Longitudinal Changes in the Fear of Recurrence Inventory Severity Subscale From Baseline to 13 Weeks

    The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of cancer recurrence. Range is 0 to 36 with higher values representing higher fear of recurrence.

    Measured: Baseline (Week 0), Week 13

  7. Longitudinal Changes in the Health Status Questionnaire (SF-36) From Baseline to 13 Weeks

    The Health Status Questionnaire (SF-36) functions as a self-reporting tool designed to evaluate an individual's quality of life. It consists of 36 items and is organized into eight subscales. Each subscale score is then translated into a linear scale that spans from 0 to 100. A higher score means enhanced quality of life. Additionally, the questionnaire incorporates two domains as mental health component and physical health component. These domains are the results of linear aggregation from the 8 subscales and transforming into T score metric. In these metrics, the t score has a mean of 50 and a standard deviation of 10 based on the characteristics of U.S. general population for both mental and physical health sub scores. A higher T-score corresponds to a higher quality of life for that subscale.

    Measured: Baseline (Week 0), Week 13

  8. Longitudinal Changes in the Impact of Events Scale-Revised (IES-R) From Baseline to 13 Weeks

    The Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure of cancer related distress. The IES-R assesses the frequency with which respondents experience intrusive thoughts, avoidant behaviors, and autonomic arousal specific to one's thoughts and feelings about cancer over the past week. Each item is rated on a 5-point scale ranging from 0("not at all") to 4("extremely"). The higher grade indicates greater stress. IES- R total score is the sum of the means of the three subscale scores. IES- R total score ranges from 0 to 12. The higher scores indicate higher cancer distress.

    Measured: Baseline (Week 0), Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start19 Jul 2018
  3. Primary completion29 Jul 2022
  4. Study completion29 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03060096
Sponsor's protocol ID
IRB00047561
Other IDs
1R21CA198237, 5R21CA198237-02, 3UG1CA189824-04S1, WF-30917CD, NCI-2017-01840
Acronym
Telehealth
Status last verified
Feb 2026
First submitted
31 Jan 2017
Last updated
27 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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