A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors

Anxiety Depression Clinical Trial

Official title:

A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03190291
• Other study ID #: REBAWF 30917CD
• Secondary ID: 5R21CA198237-023
• Status: Not yet recruiting
• Phase: N/A
• First received: June 13, 2017
• Last updated: April 24, 2018
• Start date: May 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2018
• Source: Wake Forest University Health Sciences
• Contact: Robin Rosdhal, RN, OCN
• Phone: 336-713-6519
• Email: rosdhal[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

The purpose of this study is to test a method of implementing this stepped-care approach in community oncology practices caring for rural survivors, using self-directed and telehealth approaches based on cognitive-behavioral theory.

Description:

Primary Objectives: To determine feasibility (recruitment, accrual, retention, adherence) of a Randomized Control Trial (RCT) of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care in 90 post-treatment cancer survivors with moderate or severe levels of emotional distress (anxiety and/or depressive symptoms).

Secondary Objectives:

1. To obtain preliminary data on the efficacy and variability of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care for reducing emotional distress (anxiety and/or depressive symptoms) in 90 post-treatment cancer survivors.

2. To obtain preliminary data on the efficacy and variability of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care for secondary outcomes (sleep disturbance, fatigue, fear of recurrence, and Quality of Life (QOL)) in 90 post-treatment cancer survivors.

3. To determine costs associated with both stepped-care and enhanced usual care interventions from the perspective of a healthcare provider. We will determine costs of intervention implementation and health care utilization in all arms over the course of the interventions.

4. To examine potential differential effects of the intervention on anxiety, depression, sleep disturbance, fatigue, fear of recurrence, and QOL, by gender, age, race/ethnicity, stratification arm (moderate, severe), and psychotropic medication use at baseline.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Score =10 on the Generalized Anxiety Disorder-7 (GAD-7) and/or a score =8 on the Patient Health Questionnaire-9 (PHQ-9), indicating clinically significant anxiety or depressive symptoms, respectively.

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

4. 6-60 months post-treatment (surgery, chemotherapy, radiation therapy, and/or maintenance therapies) for cancer.Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on hormonal therapies.

5. Residency in a rural zip code defined as below by the Rural-Urban Commuting Areas (RUCA) Version 3.1. Residential zip codes are assigned a RUCA code based on size of its largest population center and commuting patterns. A spreadsheet with eligibility by zip code will be provided to all participating sites.

6. Must be able to speak and understand English.

7. Must have access to a telephone

Exclusion Criteria:

1. Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days]

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

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

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

5. Global cognitive impairment based on education-adjusted scores (details below) on the Telephone Interview for Cognitive Status-modified

6. Self-reported psychotic symptoms in the last 30 days:

"Have you seen things that aren't really there or have you heard voices when no one else was around within the last 30 days?")

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

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

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

Related Conditions & MeSH terms

• Anxiety Depression

Intervention

Behavioral:
• Stepped Care: Low Intensity
Self-guided CBT workbook teaches people to monitor depressive and anxiety-producing thoughts, modify these thoughts, and modify behaviors that reinforce depression and anxiety.

Other:
• Enhanced Usual Care
Will receive information about referrals/resources in their local area, including support groups and mental health providers. They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the National Cancer Institute to assist with the transition from active treatment to survivorship.

Behavioral:
• Stepped Care: High Intensity
Will consist of the CBT workbook, plus psychotherapy delivered by telephone with a licensed therapist.

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-2 (PHQ-2)	Includes a 3-item depression/anxiety screening	Pre-Screen
Primary	Generalized Anxiety Disorder-1 (GAD-1)	Generalized Anxiety Disorder Question	Pre-Screen
Primary	Telephone Interview of Cognitive Status-modified-34 (TICS-m)	Screening measure of cognitive function based on MMSE and validated for telephone administration. Assess global cognitive impairment. Eligibility will be based on education adjusted scores. Scores at the following cut-points are eligible for the study: < 8th grade: TICS-m = 23; 8-10th grade: TICS- m = 26; 11-12th grade: TICS-m = 28; > 12th grade: TICS-m = 30.	Pre-Screen
Primary	Generalized Anxiety Disorder-7 (GAD-7)	Incorporates DSM-IV symptoms for generalized anxiety disorder. A score = 10 indicates moderate anxiety symptoms, and a score = 15 suggests severe symptoms.	Screening
Primary	Patient Health Questionnaire-9 (PHQ-9)	Self-report measure used for screening, diagnosing, monitoring and measuring the severity of depression that incorporates DSM-IV depression diagnostic criteria. A score = 8 indicates moderate depressive symptoms while a score =15 suggests severe depressive symptoms.	Screening
Secondary	Fear of Cancer Recurrence Inventory Severity Subscale (FCRI)	Will be used to measure self-reported fear of recurrence.	Baseline, Week 13
Secondary	Insomnia Severity Index	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.	Baseline, Week 13
Secondary	PROMIS-Fatigue Scale-Short Form 8a	Measure of the experience of fatigue and the impact of fatigue on activities across multiple domains.	Baseline, Week 13
Secondary	Self-Report Quality of Life (SF-36)	Self-report measure of quality of life consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy or fatigue, emotional well-being, and general health perceptions.	Baseline, Week 13
Secondary	The Impact of Events Scale - Revised (IES-R)	Self-report measure of cancer-specific distress. 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.	Baseline, Week 13
Secondary	Cornell Services Index	Assesses the frequency of use of medical outpatient visits, psychiatric and psychotherapeutic visits, and intensive services such as hospitalizations, emergency room visits, and home health visits.	Baseline, Week 13