Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-31 @ 1:25 AM
Study NCT ID:
NCT05912166
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MenteCalma
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.
* 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).
* 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3R01CA262357-02S1 | NIH | None | https://reporter.nih.gov/quic… | View |