Overview

This trial is active, not recruiting.

Conditions cancer, anxiety
Treatments health education program, cbt mobile application
Sponsor Massachusetts General Hospital
Start date September 2014
End date December 2016
Trial size 153 participants
Trial identifier NCT02286466, 12-533

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
The presence and usage of Health Education Program.
health education program
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.
(Experimental)
The presence and usage of a CBT Mobile Application.
cbt mobile application
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.

Primary Outcomes

Measure
Change in anxiety symptoms from baseline to post-assessment
time frame: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)

Secondary Outcomes

Measure
Change in quality of life from baseline to post-assessment
time frame: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)
Change in mood symptoms from baseline to post-assessment
time frame: 1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)
Change in distress (related to stressful live events) from baseline to post-assessment
time frame: 1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of a metastatic solid tumor - Report clinically significant anxiety symptoms (i.e., HADS-Anxiety Subscale > or equal to 8) - Anxiety is principal psychiatric problem - At least four weeks after cancer diagnosis - ECOG performance status of 0-2 - Age greater than 18 years - Ability to read and respond to questions in English Exclusion Criteria: - Co-morbid delirium, dementia, or active and untreated major psychiatric condidtion such as schizophrenia will be excluded from the study

Additional Information

Official title Mobile Application of Cognitive-Behavioral Therapy (CBT) for Anxiety and Cancer
Principal investigator Joseph A Greer, Ph.D.
Description Background: Patients with advanced cancer often experience marked anxiety symptoms that are associated with poor quality of life, high physical symptom burden, and complications with medical treatment. We have demonstrated in prior NCI-funded research that individual cognitive-behavioral therapy (CBT), delivered in-person at a tertiary cancer center, is efficacious for treating heightened anxiety in this population. In our randomized-controlled trial of 40 patients with incurable solid tumors, we observed significant reductions in anxiety symptoms per self-report and blind clinician evaluation, with a large effect size underscoring the clinical benefit of the CBT intervention (Cohen's d=0.80). However, timely access to CBT, especially for patients in community clinic settings, is severely limited by shortened life expectancy, scheduling challenges associated with poor functional status, and the lack of trained clinicians and onsite mental health services. Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of delivering CBT for anxiety via mobile application (app) tailored to patients with advanced cancer. We will administer the intervention at two cancer centers, hypothesizing that patients with advanced cancer who receive CBT via mobile app will report significantly greater reductions in anxiety compared to those assigned to a time-matched control group using an online health educational program. Specific Aims: The primary aims for the proposed project are 1) to adapt our successful CBT intervention for use as a self-administered, mobile application to treat anxiety in patients with advanced cancer; and, 2) to demonstrate the feasibility, efficacy, and generalizability of the CBT mobile app intervention for anxiety compared to an online health education program across two cancer centers (one academic and one community). Study Design: We will employ sequential mixed qualitative and quantitative methods for intervention adaptation and testing. Specifically, we will dedicate year one of the award to creating and scripting the CBT mobile app intervention for anxiety, which will include multiple electronic features that enhance specificity to patients' individual cancer-related concerns. Up to six patients with metastatic cancer will participate in an initial open pilot study to explore the usability and acceptability of the prototype application. Data from qualitative interviews with these participants will be used to refine and adapt the intervention further. In year two, we will enroll and randomly assign patients with anxiety and metastatic cancer to receive either the CBT mobile app intervention or an online health education program. Patients will self-administer the intervention protocol using a tablet PC. The target enrollment for the randomized-controlled trial is 120 patients (CBT Mobile App N=60; Control N=60). Randomization will be stratified by study site and disease severity to demonstrate the generalizability of the intervention among patients with diverse malignancies in both academic and community cancer care settings. Cancer Relevance: According to the American College of Surgeons Commission on Cancer Report (2011), an essential criterion for accreditation as a cancer center is timely patient access to screening and referral for treatment of psychological distress. Yet, most academic and community cancer clinics lack appropriate resources, staff, and training in evidence-based mental health therapies. The proposed project has the potential to address this critical unmet need by adapting an efficacious and clinically-meaningful CBT intervention to a patient-centered and user-friendly platform that can be accessed at home and while patients receive routine oncology care. If successful, our approach could be widely disseminated in a cost-effective manner across multiple oncology settings, greatly improving access to mental health services, especially for patients with cancer in resource-poor communities.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.