CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 145 enrolled
Drug / intervention
Health Education Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02286466
NCT02286466N/ACompleted

Mobile Application of Cognitive-Behavioral Therapy (CBT) for Anxiety and Cancer

Massachusetts General Hospital·interventional·Posted Nov 7, 2014·Updated Aug 28, 2018

In Brief

A clinical study evaluating Health Education Program and CBT Mobile Application for Cancer and Anxiety. Completed, enrolled 145 participants across 1 site.

Detailed Summary

The proposed study seeks to implement a randomized controlled trial to evaluate the effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT) intervention for use as a self-administered mobile application (mobile app) to treat anxiety in patients with metastatic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Anxiety
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 7, 2014
Enrollment StartFeb 18, 2015
Primary CompletionOct 25, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.7 years ago

Interventions

Health Education Programbehavioral

Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.

CBT Mobile Applicationbehavioral

The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.