Stepped-Care Telehealth for Distress in Cancer Survivors

Wake Forest University Health Sciences68 enrolled

Overview

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.

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.

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (166)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Start of study screening time to end of study accrual

Secondary Outcomes

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: Week 13

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.