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

NCT05912166 | Completed

• 2 other identifiers: NU 23CC023R01CA262357-02S1
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cancer

Keywords

cancer; young adult; e-health; mindfulness; remote-delivered; Spanish-language; international; Colombia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Change in mindful self-compassion

  pre-intervention; post intervention

• Change in symptom burden of anxiety

  pre-intervention; post intervention

• Change in symptom burden of depression

  pre-intervention; post intervention

• Change in perceived stress

  pre-intervention; post intervention

• Change in health behaviors

  pre-intervention; post intervention

Other Outcomes (3)

• Meditation experience in young adult cancer survivors

  pre-intervention

• Treatment expectancy in young adult cancer survivors

  pre-intervention

• Socio-demographic and clinical factors in mindfulness program participation

  pre-intervention

Study Arms (1)

Wakeful Spanish

EXPERIMENTAL

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

Interventions

Wakeful Spanish BEHAVIORAL

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.

Wakeful Spanish

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Hospital Universitario San Ignacio Pontificia Universidad Jveriana

Bogotá, Capital District Cundinamarca, 110231, Colombia

Location

Related Publications (32)

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  BACKGROUND

• Victorson D, Guitelman, J, DeArrudah, H, Van Hyfte, G, Pedersen, J, Oyola, S. Community-Engaged Yoga Research with Monolingual Spanish Speaking Women Diagnosed with Cancer: Findings from a Non-Randomized Pilot Study. Oral presentation at the 2017 Osher Integrative Medicine Research Conference. 2017;Chicago, IL.

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MeSH Terms

Conditions

Neoplasms

Study Officials

• David E Victorson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Siobhan M Phillips, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: February 27, 2024
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CO (1)