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

2017-06-19 02:51:12 | BioPortfolio


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.


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.

Study Design


Anxiety Depression


Stepped Care: Low Intensity, Enhanced Usual Care, Stepped Care: High Intensity


Wake Forest School of Medicine
North Carolina
United States


Not yet recruiting


Wake Forest University Health Sciences

Results (where available)

View Results


Published on BioPortfolio: 2017-06-19T02:51:12-0400

Clinical Trials [12742 Associated Clinical Trials listed on BioPortfolio]

Stepped Care for Depression in Heart Failure

This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention includes cognitive behavior therapy (CBT), plus antidepressant medicatio...

Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)

The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in...

Stepped Care for Depression and Musculoskeletal Pain

This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

Comparison of Two Counseling Induction Strategies

New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on methadone and randomly assigned to one of two induction conditions: 1) routine stepped care, or 2) ...

Collaborative Care Intervention for Cancer Caregivers

The proposed randomized controlled trial will test the efficacy of a stepped collaborative care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers. Bio...

PubMed Articles [19158 Associated PubMed Articles listed on BioPortfolio]

A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT.

This trial examined whether a stepped care program for depression, which initiated treatment with internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-r...

The cost-effectiveness of stepped care for the treatment of anxiety disorders in adults: A model-based economic analysis for the Australian setting.

To evaluate the cost-effectiveness of stepped care compared to care as usual (CAU) for the treatment of adults with mild-to-moderate anxiety disorders from a health sector perspective in the Australia...

A stepped care intervention for non-specialist health workers' management of depression in the Mental Health in Primary Care (MeHPriC) project, Lagos, Nigeria: A cluster randomised controlled trial.

The study aimed to evaluate the clinical effectiveness of a developed stepped care intervention for management of depression in primary care.

Screening and Stepped Care Targeting Psychological Distress in Patients With Metastatic Colorectal Cancer: The TES Cluster Randomized Trial.

This study evaluated the effectiveness of a screening and stepped care program (the TES program) in reducing psychological distress compared with care as usual (CAU) in patients with metastatic colore...

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international recommendations. The objective of this stu...

Medical and Biotech [MESH] Definitions

Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.

Medical care provided after the regular practice schedule of the physicians. Usually it is designed to deliver 24-hour-a-day and 365-day-a-year patient care coverage for emergencies, triage, pediatric care, or hospice care.

An interval of care by a health care facility or provider for a specific medical problem or condition. It may be continuous or it may consist of a series of intervals marked by one or more brief separations from care, and can also identify the sequence of care (e.g., emergency, inpatient, outpatient), thus serving as one measure of health care provided.

Advanced and highly specialized care provided to medical or surgical patients whose conditions are life-threatening and require comprehensive care and constant monitoring. It is usually administered in specially equipped units of a health care facility.

Health care provided during a transition to a different mode of care (e.g., TRANSITION TO ADULT CARE).

More From BioPortfolio on "A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors"

Quick Search

Relevant Topics

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Searches Linking to this Trial