Stepped-Care Telehealth for Distress in Cancer Survivors

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.

Conditions

• Anxiety
• Depressive Symptoms
• Sleep Disturbance
• Recurrent Disease
• Fatigue
• Quality of Life
• Cancer

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Suzanne Danhauer, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-19

Primary Completion

2022-07-29

Completion

2022-07-29

Countries

• United States

Study Locations