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Stepped-Care Telehealth for Distress in Rural Cancer Survivors (Telehealth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03060096
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date May 21, 2020
Actual Study Start Date  ICMJE July 19, 2018
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • Feasibility of study intervention measured by recruitment rate [ Time Frame: 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.
  • Feasibility of study intervention measured by accrual rate [ Time Frame: Screening through end of study at week 13 ]
    Accrual rates will be calculated by calculating the mean number of participants recruited per month.
  • Feasibility of study intervention measured by adherence to intervention [ Time Frame: 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.
  • Feasibility of study intervention measured by retention [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2017)
  • Longitudinal changes in the Generalized Anxiety Disorder-7 (GAD-7) score for anxiety [ Time Frame: 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.
  • Longitudinal changes in the Patient Health Questionnaire (PHQ-9) score for depression [ Time Frame: 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.
  • Combined analysis of PHQ-9 and GAD-7 [ Time Frame: 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.
  • Longitudinal changes in the Insomnia Severity Index (ISI) [ Time Frame: 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.
  • Longitudinal changes in the PROMIS Fatigue Scale [ Time Frame: 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.
  • Longitudinal changes in the Fear of Recurrence Inventory Severity Subscale [ Time Frame: 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.
  • Longitudinal changes in the Health Status Questionnaire (SF-36) [ Time Frame: 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.
  • Determine costs associated with stepped care mental health and enhanced usual care [ Time Frame: 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
  • Analysis of differential effects of intervention measured by subgroup stratification [ Time Frame: 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.
  • Longitudinal changes in the Impact of Events Scale-Revised (IES-R) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • Longitudinal changes in the GAD-7 score for anxiety [ Time Frame: 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.
  • Longitudinal changes in the PHQ-9 score for depression [ Time Frame: 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. Longitudinal changes in the PHQ-9 will be measured in participants to evaluate the effectiveness of the intervention in reducing depression.
  • Combined analysis of PHQ-9 and GAD-7 [ Time Frame: 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.
  • Longitudinal changes in the Insomnia Severity Index (ISI) [ Time Frame: Baseline (Week 0), Week 13 ]
    The Insomnia Severity Index is a 7-item self report measure of type and severity of insomnia symptoms. Longitudinal changes in the ISI will be measured in participants to evaluate the effectiveness of the intervention on problems with sleep.
  • Longitudinal changes in the PROMIS Fatigue Scale [ Time Frame: 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. Longitudinal changes in the PROMIS Fatigue Short Form will be measured in participants to evaluate the effectiveness of the intervention on problems with fatigue.
  • Longitudinal changes in the Fear of Recurrence Inventory Severity Subscale [ Time Frame: 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. Longitudinal changes in the FCRI scores will be measured in participants to evaluate the effectiveness of the intervention on fear of cancer recurrence.
  • Longitudinal changes in the Health Status Questionnaire (SF-36) [ Time Frame: Baseline (Week 0), Week 13 ]
    The Health Status Questionnaire (SF-36) is a self-report measure of 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.
  • Determine costs associated with stepped care mental health and enhanced usual care [ Time Frame: 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
  • Analysis of differential effects of intervention measured by subgroup stratification [ Time Frame: 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.
  • Longitudinal changes in the Impact of Events Scale-Revised (IES-R) [ Time Frame: Baseline (Week 0), Week 13 ]
    The IES-R is a 22-item self-report measure of cancer-specific distress. Longitudinal changes in the IES-R scores will be measured in participants to evaluate the effectiveness of the intervention on cancer-specific distress.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stepped-Care Telehealth for Distress in Rural Cancer Survivors
Official Title  ICMJE Stepped-Care Telehealth for Distress in Rural Cancer Survivors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety
  • Depressive Symptoms
  • Sleep Disturbance
  • Recurrent Disease
  • Fatigue
  • Quality of Life
  • Cancer
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Moderate Anxiety/depression: Low Intensity Stepped care
  • 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.
    Intervention: Other: Severe Anxiety/depression: High Intensity Stepped Care
  • 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.
    Intervention: Other: Enhanced Usual Care Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
120
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)28,29 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.
  • 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.
  • Global cognitive impairment based on education-adjusted scores on the Telephone Interview for Cognitive Status-modified
  • 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 )
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Craver, MT, MHA (336) 716-0891 NCORP@wakehealth.edu
Contact: Suzanne Danhauer, PhD 336-716-0891 danhauer@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03060096
Other Study ID Numbers  ICMJE IRB-00047561
1R21CA198237 ( U.S. NIH Grant/Contract )
5R21CA198237-02 ( U.S. NIH Grant/Contract )
3UG1CA189824-04S1 ( U.S. NIH Grant/Contract )
WF-30917CD ( Other Identifier: NCI )
NCI-2017-01840 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Suzanne Danhauer, PhD Wake Forest Baptist Medical Center
PRS Account Wake Forest University Health Sciences
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP