Clinical trial NCT05912166: Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness
Official title: Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer
young adult
e-health
mindfulness
remote-delivered
Spanish-language
international
Colombia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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).

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

Primary outcomes:
measure: Implementation feasibility measured by enrollment rate
timeFrame: continuously for 9 weeks
measure: Implementation feasibility measured by retention rate
timeFrame: continuously for 9 weeks
measure: Implementation feasibility measured by completion rate
timeFrame: continuously for 9 weeks
measure: Acceptability of the Wakeful program as measured by a post-intervention evaluation survey
timeFrame: post-intervention
measure: Acceptability of the Wakeful program as measured by mindfulness reflections
timeFrame: continuously for 9 weeks
measure: Adherence to the Wakeful program
timeFrame: continuously for 9 weeks
Secondary outcomes:
measure: Change in mindful self-compassion
timeFrame: pre-intervention; post intervention
measure: Change in symptom burden of anxiety
timeFrame: pre-intervention; post intervention
measure: Change in symptom burden of depression
timeFrame: pre-intervention; post intervention
measure: Change in perceived stress
timeFrame: pre-intervention; post intervention
measure: Change in health behaviors
timeFrame: pre-intervention; post intervention
measure: Change in leisure time physical activity
timeFrame: pre-intervention; post intervention
Other outcomes:
measure: Meditation experience in young adult cancer survivors
timeFrame: pre-intervention
measure: Treatment expectancy in young adult cancer survivors
timeFrame: pre-intervention
measure: Socio-demographic and clinical factors in mindfulness program participation
timeFrame: pre-intervention
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio Pontificia Universidad Jveriana
state: Capital District Cundinamarca
Study officials:
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Siobhan M Phillips, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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