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

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

NCT ID: NCT05912166

Condition: Cancer

Conditions: Keywords:
cancer
young adult
e-health
mindfulness
remote-delivered
Spanish-language
international
Colombia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention 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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Wakeful Spanish
Description: 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 - 1. Write what they observed during meditations. 2. Be guided by videos/audios through breathing exercises and gentle stretching. 3. See what others experienced and their tips for overcoming challenges. 4. Access videos/audios that explain how mindfulness benefits the body and mind. 5. Receive suggestions on meditations to do during the week 6. Set an intention for the week based on class content.
Arm group label: Wakeful Spanish

Summary: 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: 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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 39 Years

Healthy volunteers: No

Locations:

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Not yet recruiting

Contact:
Last name: David E Victorson, PhD

Phone: 847-467-3060
Email: d-victorson@northwestern.edu

Facility:
Name: Hospital Universitario San Ignacio Pontificia Universidad Jveriana

Address:
City: Bogotá
Zip: 110231
Country: Colombia

Status: Recruiting

Contact:
Last name: Raúl Murillo Moreno, MD, MPH

Phone: +57 1 5946161

Phone ext: 4210
Email: rmurillo@husi.org.co, raul-murillo@javeriana.edu.co

Start date: February 27, 2024

Completion date: July 31, 2024

Lead sponsor:
Agency: Northwestern University
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Northwestern University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05912166