Clinical trial NCT02286466: Mobile App of CBT for Anxiety and Cancer
Official title: Mobile Application of Cognitive-Behavioral Therapy (CBT) for Anxiety and Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Anxiety Symptoms From Baseline to Post-assessment
timeFrame: 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
timeFrame: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)
measure: Change in Mood Symptoms From Baseline to Post-assessment
timeFrame: 1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)
measure: Change in Depression Symptoms From Baseline to Post-assessment
timeFrame: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph A Greer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: