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COMPLETED NA

Stepped-Care Telehealth for Distress in Cancer Survivors

NCT03060096 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER Severe Anxiety/depression: High Intensity Stepped Care
  • OTHER Moderate Anxiety/depression: Low Intensity Stepped care
  • OTHER Enhanced Usual Care Control

Study Locations (20)

Illinois

  • Rush - Copley Medical Center — Aurora
  • Illinois CancerCare-Bloomington — Bloomington
  • Illinois CancerCare-Canton — Canton
  • Memorial Hospital of Carbondale — Carbondale
  • SIH Cancer Institute — Carterville
  • Illinois CancerCare-Carthage — Carthage
  • Centralia Oncology Clinic — Centralia
  • Carle on Vermilion — Danville

California

  • Kaiser Permanente-Fresno — Fresno
  • Kaiser Permanente-Modesto — Modesto
  • Kaiser Permanente-South Sacramento — Sacramento
  • Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo
  • Kaiser San Rafael-Gallinas — San Rafael
  • Kaiser Permanente-Santa Rosa — Santa Rosa
  • Kaiser Permanente-Stockton — Stockton

Georgia

  • Augusta University Medical Center — Augusta
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah
  • Low Country Cancer Care Associates PC — Savannah
  • Summit Cancer Care-Candler — Savannah

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2018-07-19
Est. Completion 2022-07-29
Phase NA

Sponsor

Wake Forest University Health Sciences

1,061 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03060096

The ClinicalTrials.gov registry entry for NCT03060096 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions — of which Severe Anxiety/depression: High Intensity Stepped Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03060096 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Illinois, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03060096 about?

NCT03060096 is a clinical study titled "Stepped-Care Telehealth for Distress in Cancer Survivors". 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 C...

What is the current status of trial NCT03060096?

This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2018-07-19. Estimated completion is 2022-07-29.

What conditions does trial NCT03060096 study?

This clinical trial studies the following conditions: Cancer, Anxiety, Fatigue, Quality of Life, Depressive Symptoms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03060096?

The interventions under investigation include: Severe Anxiety/depression: High Intensity Stepped Care (OTHER), Moderate Anxiety/depression: Low Intensity Stepped care (OTHER), Enhanced Usual Care Control (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03060096?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03060096 being conducted?

This trial has 20 study locations across Arkansas, California, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial