Clinical Trials Directory

Trials / Terminated

TerminatedNCT04705025

Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer

Phase II Pilot Study Evaluating the Feasibility of Delivery and Evaluation of a Digital Cognitive-Behavioral Stress Management (CBSM) Device (BNT001) for Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Stage I-III Non-Small Cell Lung Cancer

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Jonsson Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the effect of a digital application (app), BNT001, on cognitive-behavioral stress management in patients with stage I-III breast or lung cancer. The app is designed for cancer patients to treat anxiety and depressive symptoms related to their cancer diagnosis. The purpose of this study is to develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app prior to the launch of a phase III randomized trial. The impact of the app in managing stress and improving quality of life and mood is a secondary aim.

Detailed description

PRIMARY OBJECTIVE: I. To assess the feasibility of implementing and evaluating a digital cognitive-behavioral stress management (CBSM) device, BNT001, in stage I-III breast or stage I-III non-small cell lung cancer currently undergoing treatment or recently completed treatment (\< 3 months). SECONDARY OBJECTIVES: I. To collect preliminary data regarding the efficacy of the intervention with regard to improvements in patients' reported symptoms of distress. II. To evaluate patient safety and risks associated with screening procedures (severe anxiety or depression) as well as during receipt of the digital intervention. OUTLINE: Prior to participating in the study patients complete an online baseline questionnaire to assess anxiety and depression and general quality of life, as well as some specific questions related to their coping. They are also interviewed by a clinician who rates their level of anxiety and depression. After this, patients use the BNT001 app and undergo 10 sessions of CBSM over 45-60 minutes each consisting of cancer-specific educational videos, guided relaxation training, interactive exercises, and discussion modules. Following completion of the 5th session, patients undergo a telephone check-in assessment to see how things are going, update their treatments and medications, and schedule a phone call to assess for adverse events. At the end of the 10th session, patients complete a post-treatment online questionnaire and a phone debriefing interview to discuss their experience with the intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavior TherapyUndergo CBSM using the BNT001 app
OTHERInterviewComplete interview
OTHERQuality-of-Life AssessmentAncillary studies
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2021-04-08
Primary completion
2023-03-30
Completion
2023-03-30
First posted
2021-01-12
Last updated
2023-07-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04705025. Inclusion in this directory is not an endorsement.