Mobile App of CBT for Anxiety and Cancer

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.
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.

Inclusion Criteria:

- Diagnosis of a metastatic solid tumor

- Report clinically significant anxiety symptoms (i.e., Hospital Anxiety and Depression
Scale (HADS) -Anxiety Subscale > or equal to 8)

- Anxiety is principal psychiatric problem

- At least four weeks after cancer diagnosis

- Eastern Cooperative Oncology Group (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 condition such
as schizophrenia will be excluded from the study