Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness

Study Overview
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Brief Summary
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The purpose of this international oncology research includes the following three aims: Aim 1. Expand and strengthen the existing research partnership with investigators from Centro Javeriano de Oncología, Pontificia Universidad Javeriana, and Hospital Universitario San Ignacio in Bogotá, Colombia. Aim 2. Evaluate the implementation feasibility and acceptability of the 9-week Spanish-translated mindfulness app, Wakeful, in a mixed Colombian young adult cancer patient sample. Aim 3. Translate and record professional Spanish-language voice overs for all new STU00210628 content for future implementation.

Detailed Description
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The purpose of this international oncology research includes the following three aims: Aim 1. Expand and strengthen the existing research partnership with investigators from Centro Javeriano de Oncología, Pontificia Universidad Javeriana, and Hospital Universitario San Ignacio in Bogotá, Colombia. Aim 2. Evaluate the implementation feasibility and acceptability of the 9-week Spanish-translated mindfulness app, Wakeful, in a mixed Colombian young adult cancer patient sample. Aim 3. Translate and record professional Spanish-language voice overs for all new STU00210628 content for future implementation. The research is a collaborative study. All research activities, except implementation of the Wakeful intervention-related research activities, will be conducted by Centro Javeriano de Oncologia research staff, and data collection will take place online via Zoom and REDCap accounts. Northwestern research staff will be involved in Wakeful app intervention related activities (i.e., conducting the Wakeful orientation via Zoom; providing Wakeful intervention management and technical support; data collection via the Wakeful app; sending reminders via the Wakeful app, following-up with participants who have not used the Wakeul app in 14 days; and data analysis). The following are the study sites: Northwestern University and Centro Javeriano de Oncologia. This study will not seek sIRB or reliance agreement. Each site will seek local IRB approval. The research investigators will conduct a pre-post feasibility study. Thirty men and women will complete a 9-week online course. Participants will be assessed at baseline just prior to the start of the course (T1), followed by assessments at 9 weeks (T2). Following consent, participants will be immediately directed to a secure REDCap survey URL to complete the T1 (baseline) survey. The survey will take approximately 20-30 minutes to complete. Next, participants will receive an email invitation to participate in a Wakeful orientation via Zoom, during which they will receive an email from the Wakeful app inviting them to register. By clicking the Create Password button in the email invitation, they will be directed to the Wakeful registration page where they will create a unique username and password. Wakeful will then prompt them to confirm their username and password and sign in. Once they sign in, Wakeful will prompt them to watch a brief video orientation and begin the 9-week self-directed course. Within 24 hours of completing the 9 Wakeful classes, a participant will receive an email with instructions and a link to complete the T2 survey. At the end of participation, no other information will be collected by the app; however, participants will still have access to specific features of the app (i.e., the mindfulness videos for review and the timer for continued practice) in the event they would like to continue their mindfulness practice after study participation. Spanish-language assessments will occur over the internet through a secure REDCap platform. Outcome measures include: socio-demographic and clinical information (gathered at T1); feasibility metrics (gathered on an ongoing basis throughout the study); acceptability and satisfaction metrics (gathered at T2); usability metrics (gathered on an ongoing basis throughout the study); and health related quality of life and wellbeing measures (gathered at all time-points unless otherwise indicated).

Official Title
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Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Wakeful Spanish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer Age 18-39 years at time of enrollment Under treatment or within 3 years of having completed primary cancer treatment (i.e., surgery, chemotherapy, or radiation) at time of enrollment Access to a device with Wifi (e.g., smartphone, computer, tablet) Fluency in spoken and written Spanish Exclusion Criteria: Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship Inability to provide informed consent Prisoners or other detained individuals at time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The researchers will collect implementation feasibility and acceptability data of the 9-week Spanish-language Wakeful app in a mixed sample of young adult cancer survivors (n=30) between 18-39, using a single arm pre-post test design. Following consent, participants will be immediately directed to a secure Redcap assessment URL to complete the T1 assessment. Next, participants will be sent an email to access the Wakeful web app where they will watch a brief video orientation and begin the 9-week self-directed course. After 9 weeks, participants will be emailed a secure URL to complete the T2 assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wakeful Spanish<br>Wakeful Spanish is the Spanish-language version of Wakeful, developed at Northwestern University. It is a self-directed 9-week digital mindfulness course closely aligned with traditional 8-week Mindfulness-based Stress Reduction (MBSR) programs. | Behavioral: Wakeful Spanish<br>* Wakeful Spanish is the Spanish-language version of Wakeful, a self-directed 9-week digital mindfulness course closely aligned with traditional 8-week Mindfulness-based Stress Reduction (MBSR) programs. Wakeful makes one new class available to users each week for 9 weeks. Users receive weekly email notifications from Wakeful informing them when a new class is available. Estimated class duration is 1-1.5 hours. With Wakeful, users can - Write what they observed during meditations. Be guided by videos/audios through breathing exercises and gentle stretching. See what others experienced and their tips for overcoming challenges. Access videos/audios that explain how mindfulness benefits the body and mind. Receive suggestions on meditations to do during the week Set an intention for the week based on class content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation feasibility measured by enrollment rate | This indicator of implementation feasibility for the intervention delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached). Enrollment rate will be tracked continuously during the 9-week study. | continuously for 9 weeks | 
| Implementation feasibility measured by retention rate | This indicator of implementation feasibility for the intervention delivered is defined by the retention rate being >/= 70% (e.g., total number of participants who drop out/ total number enrolled). Retention rate will be tracked continuously during the 9-week study. | continuously for 9 weeks | 
| Implementation feasibility measured by completion rate | This indicator of implementation feasibility for the intervention delivered is defined by the overall completion rate being >/= 70% (e.g., total number of individuals completed/total number enrolled). Completion rate will be tracked continuously during the 9-week study. | continuously for 9 weeks | 
| Acceptability of the Wakeful program as measured by a post-intervention evaluation survey | Acceptability will be measured using a Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as >/= 70% of survey responses in affirmation of this. | post-intervention | 
| Acceptability of the Wakeful program as measured by mindfulness reflections | Acceptability of the Wakeful program as measured by mindfulness reflections written by participants in the Wakeful app will be collected continuously during the 9-week study. Written mindfulness reflections downloaded, de-identified, and coded using Dedoose, a collaborative, web-based application that facilitates all types of research data management and analysis. The study team will identify common themes, create definitions, and develop coding rules regarding specific group comments. The comments will then be compiled and summarized in frequency tables denoting the number of times responses were made. Results will be summarized according to thematic area. | continuously for 9 weeks | 
| Adherence to the Wakeful program | Adherence to the Wakeful program will be monitored and usage tracked continuously during the 9-week study. Data include the following: Number of times a user: logs into the Wakeful app; opens the educational videos; opens the audio files; opens the audio files; acknowledges or comments on other users' reflections Number of minutes a user spends: logged into the Wakeful app; on the educational videos; on the audio files; writing into the reflection text boxes; acknowledging or commenting on other users' reflections | continuously for 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mindful self-compassion | Mindful self-compassion will be measured using the Self-Compassion Scale-12. This short form is a 12-item scale measuring items related to self-kindness, self-judgment, and common humanity. Statements on the Self-Compassion Scale are scored on a Likert scale of 1 (almost never) to 5(almost always). To calculate an overall compassion score - Items representing uncompassionate responses to inadequacy or suffering (the self-judgment, isolation, and over-identification subscales) are reverse-coded only when calculating the overall compassion score. In this way, higher scores represent a lower frequency of these responses. | pre-intervention; post intervention | 
| Change in symptom burden of anxiety | Symptom burden of anxiety will be measured at baseline and week 9 using the PROMIS 4-Item Short Forms of Anxiety. This 4-item scale measures uses a 5-point Likert scale (1=never to 5=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome. | pre-intervention; post intervention | 
| Change in symptom burden of depression | Symptom burden of anxiety will be measured at baseline and week 9 using the PROMIS 4-Item Short Forms of Depression. This 4-item scale measures uses a 5-point Likert scale (1=never to 5=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome. | pre-intervention; post intervention | 
| Change in perceived stress | Change in perceived stress will be measured using the Perceived Stress Scale-10. This short form is a 10-item scale measuring items related to perceived stress. Items are scored on a Likert scale of 0 (never) to 4(very often). Items representing unperceived stress responses are reverse-coded when calculating the overall score. In this way, lower scores indicate better outcome. | pre-intervention; post intervention | 
| Change in health behaviors | Change in health behaviors will be assessed using the Enacted Health Behaviors Questionnaire-10, a local questionnaire developed by the study researchers. Participants will report on the following: consumption frequency of red meat, grains, fruits and vegetables; use of cigarettes, tobacco products, and alcohol, preventive medications, vitamins, supplements, and medical screening tests; and engagement in regular physical exercise, meditation, and yoga. Unhealthy behaviors will be reverse scored. Higher scores represent better outcome. Significant change will be indicated by p<.05 on reported health behaviors between pre- and post-intervention. | pre-intervention; post intervention | 
| Change in leisure time physical activity | Change in leisure time physical activity will be measured using the Godin Leisure Time Exercise Questionnaire Physical Activity. This is a measure of self-reported physical activity participation. Participants report times per week they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the average duration each time you exercised (in minutes) for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome. | pre-intervention; post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colombia, cancer, young adult, e-health, mindfulness, remote-delivered, Spanish-language, international