Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
Phase: NA
Conditions: Depression, Anxiety, Engagement, Patient
Sponsor: University of Virginia

Mobile Apps to Reduce Distress in Breast Cancer Survivors using an Adaptive Design 
NCT04583891 
Document Date: 07/17/2021 
 
 

Participants and recruitment: We will recruit 313 adult women diagnosed with breast 
cancer (stages 1-3) in the last 5 years (see Power analysis section in c.2.iii for 
justification of sample size). Only participants who screen high in symptoms of 
depression and/or anxiety will be enrolled. We will use both online and offline 
advertising, for recruitment including support from the Cancer Support Community 
online (https://www.cancersupportcommunity.org)  
Inclusion criteria. (1) age ≥ 18 years;(2) 0-5 years post-diagnosis of Stage I, II, or III 
female breast cancer; (3) elevated symptoms of depression and/or anxiety as measured 
by the PHQ-8 (score ≥10) or GAD-7 (score ≥8).  
Exclusion criteria. (1) receiving or scheduled to initiate individual (1 on 1) treatment for 
depression and/or anxiety to avoid treatment interference (note, individuals will be 
permitted to enroll if they are taking antidepressant medication and have not had an 
appointment to adjust the dosage over the past 2 weeks); (2) mental health condition 
deemed to interfere with study procedures or put the participant at undue risk based on 
self-reported history of psychosis or bipolar disorder, or active suicidal ideation that 
necessitates more intense care as indicated from the Columbia-Suicide Severity Rating 
Scale (C-SSRS); (3) do not have an app-compatible phone (i.e., iOS 10.3 or later or 
Android 4.0.3 or later); and (4) cannot read and speak English (apps and coaching only 
available in English).  
Survivors may be included if they are currently receiving or have concluded any cancer 
treatment (i.e., surgery, chemotherapy, radiation therapy, or hormonal therapy). 
Although we considered narrowing our criteria to exclude those treated with hormonal 
therapy or chemotherapy, given their impact on mood and their potential impact on app 
uptake, we sought to investigate the efficacy of IntelliCare for a broad population of 
breast cancer survivors to increase the generalizability of findings. We will assess 
treatment factors which will allow us to characterize our sample and to examine whether 
treatment factors are related to app usage. The process of randomization should 
distribute the cancer treatment factors evenly across the IntelliCare and Patient 
Education conditions, thereby reducing risk of confounding the impact of treatment on 
outcomes.  
Procedure: Figure 1 depicts the flowchart of study procedures.  
Screening, enrollment, and preassessment: Interested cancer survivors will see our 
advertisement (Step 1), and respond by either going to our website to read the study 
description details and/or calling a toll-free number to discuss the details with a member 
of the research staff. Then, if appropriate and motivated, individuals will be directed to 
complete a brief online interest screen (Step 2) which will be automatically stored and 
then reviewed by staff to determine initial eligibility (Step 3). Ineligible individuals will be 
informed that they do not qualify for the study. The study coordinator will speak by 

phone (Steps 4 and 5) to individuals pre-
eligible based on their screener results to 
inform them about the study, answer all 
study questions, ensure eligibility using the 
phone screen, review the consent form, and 
instruct participants about the online 
informed consent process. Online consent 
forms will be completed using the IRB-
approved procedure for our other digital 
intervention studies. A detailed medical 
history of eligible participants will also be 
taken. Participants will then complete the 
online pre-assessment battery online (Step 
6). It is estimated that the pre-assessment 
battery will take 45-60 minutes to complete.  
Stage 1 Randomization: After completing the 
pre-assessment battery, participants will be 
randomized to 1 of 2 conditions: 1) 
IntelliCare apps; or 2) App-delivered Patient 
Education (Steps 7 and 8). Following the 
procedure in prior IntelliCare trials, 
participants will receive a brief (10 min) 
enrollment call to make sure they can 
download and use the apps. We will use an 
existing onboarding phone protocol from 
prior trials. Specifically, the protocol walks 
the user through downloading the apps from 
the Google Play or iTunes store, enter their Study ID, and allows participants to ask 
questions before accepting the app use permissions. These permissions must be 
accepted in order for the apps to work.  
Stage 2 Randomization: After monitoring app use for the first week of enrollment, 
participants who received the IntelliCare apps and are low-engagers of the intervention 
will be randomly assigned to receive added coaching or no change (Steps 9 and 10). 
Breast cancer survivors receiving the app-delivered Patient Education (i.e., control 
condition) will not be re-randomized.  
Post-assessment and follow-up assessments: At the start of week nine, regardless of 
intervention progress or experimental group, participants will be instructed to complete 
the online post-assessment battery (Step 11). The post-assessment is similar to the 
pre-assessment battery but also includes the intervention evaluation measures, as used 
in our previous digital intervention studies, which provide, in part, insight into the utility, 
preference, and perceived efficacy of the intervention. After completing the post-

assessment battery, individuals will have continued access to their assigned program. 
Those that received added coaching will no longer receive coaching after the start of 
week nine, but will continue to have access to the apps. This same assessment battery 
will be completed again at 6 month (Step 12) and 12 month (Step 13) follow-ups. 
Participants will receive $50 for completing the post, another $50 for completing the 6-
month follow-up, and $100 for completing the 12-month follow up (total = $200 as online 
gift certificates).  
We will also conduct semi-structured interviews at the start of week nine with 
participants randomized to receive IntelliCare. This will enable us to identify the key 
themes, if any, to guide potential tailoring of the IntelliCare apps for a future study that 
will compare the tailored apps against the standard (i.e., untailored) apps. Individual 
interviews will include questions on how the apps meet their needs as a breast cancer 
survivor and specific changes to the apps that would make them more applicable. 
Potential themes that may be expressed by survivors may include using specific breast 
cancer examples, modifications to app look and feel, language used throughout the 
app, or the need for a new app component like dealing with fatigue or survivorship care 
planning. Information gathered from the interviews will then be used to inform possible 
modifications of the apps for use in a future study. In addition, we will also assess 
participants’ preferences to receiving coaching, if any, among the low-engagers who 
received coaching in the IntelliCare condition. Interviews will assess the 
appropriateness of the timing, duration, frequency, and usefulness of coaching calls, as 
well as ways to improve the content of coaching calls for breast cancer survivors.  
Coaching. Low-engager individuals who are randomized to the added coaching 
condition will receive coaching in addition to the standard IntelliCare apps. Coaching will 
be provided throughout the 8-week intervention period to those assigned to this 
condition. A coaching manual was developed for the pilot study of the IntelliCare apps 
among breast cancer survivors, and was modelled on a manual developed and refined 
by co-Investigator Mohr and consultant Lattie. The manual is based on the Efficiency 
Model of Behavioral Intervention Technology Support.  
Coaching is meant to support participants’ utilization of the IntelliCare apps. Coaches 
target potential points at which users may fail to benefit from the program. These “failure 
points” include issues related to the usability of the program, engagement with it, fit of 
the program tool to one’s needs, knowledge of how to use the program, and 
implementation failures (e.g. one practices the skills using the program tools, but does 
not use them in day to day life). Once a failure point is identified, the coach provides 
support to the user to help address the obstacles that may be in the way of using the 
application. In keeping with prior studies, coaches will not be providing traditional 
counseling or psychotherapy. Rather, the coaching is focused on identifying and 
addressing barriers to application utilization. An initial 30-45 minute coaching call will 
focus on orienting participants to using the apps, setting expectations of the coach’s 
role, assessing how the apps may meet participants’ needs, and building rapport. This 

will be done in a semi-structured interview format. Participants will also be encouraged 
to contact coaches at any time, using email or text, with any app-related questions. 
Following the initial coaching call, participants will receive a text message every week 
from the coach to remind them to download and try 1-2 new IntelliCare apps. We will 
conduct fidelity assessments based on procedures from prior IntelliCare trials. 
Bachelor’s degree-level coaches will be trained and monitored by the PI (Dr. Chow) with 
the support of consultant Lattie, who each have a PhD in clinical psychology and over 8 
years of experience in conducting psychological assessments and psychotherapy. 
Coaches will receive a detailed coaching manual and will attend weekly supervision 
meetings throughout the trial. Coaches will also be trained to use an existing 
researcher-facing web portal, which has been used in multiple IntelliCare trials, to track 
app usage as well as send and receive text messages.