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

Cancer Clinical Trial

— MenteCalma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912166
• Other study ID #: NU 23CC02
• Secondary ID: 3R01CA262357-02S
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: David E Victorson, PhD
• Phone: 847-503-3465
• Email: d-victorson[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Wakeful Spanish
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.

Locations

Country	Name	City	State
Colombia	Hospital Universitario San Ignacio Pontificia Universidad Jveriana	Bogotá	Capital District Cundinamarca
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Colombia, 

References & Publications (32)

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Victorson D, Banas J, Smith J, Languido L, Shen E, Gutierrez S, Cordero E, Flores L. eSalud: designing and implementing culturally competent ehealth research with latino patient populations. Am J Public Health. 2014 Dec;104(12):2259-65. doi: 10.2105/AJPH.2014.302187. Epub 2014 Oct 16. — View Citation

Victorson D, Du H, Hankin V, et al. MINDFULNESS BASED STRESS REDUCTION DECREASES FEAR OF PROGRESSION OVER TIME FOR MEN WITH PROSTATE CANCER ON ACTIVE SURVEILLANCE: RESULTS FROM A RANDOMIZED CLINICAL TRIAL. The Journal of Urology. 2012;187(4S):384.

Victorson D, Garland, E, Hanley, A, Greco, C. Is Mindfulness Immeasurable? Discovery and Dialogue of Conceptual, Practical, Scientific, and Experiential Solutions. Global Advances in Health and Medicine. 2018 7(1160):13.

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.

Victorson D, Hankin V, Burns J, Weiland R, Maletich C, Sufrin N, Schuette S, Gutierrez B, Brendler C. Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. Psychooncology. 2017 Aug;26(8):1155-1163. doi: 10.1002/pon.4135. Epub 2016 May 3. — View Citation

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Victorson D, Maletich, C, Sufrin, N, Schuette, S, Gutierrez, B, Cordero, E, Johnson, C, Stencel, D, Bakosh, L, Ring, M. Development of a New Clinical Mindfulness Research Tool to Enhance, Deliver and Streamline Online Mindfulness Interventions. THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE. 2016;0(0):A21.

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Victorson DK, M.; Maletich, C.; Lawton, R.C.; Hankin Kaufman, V.; Borrero, M.; Languido, L.; Lewett, K.; Pancoe, H.; Berkowitz, C. . A Systematic Review and Meta-Analysis of Mindfulness-Based Randomized Controlled Trials Relevant to Lifestyle Medicine. . American Journal of Lifestyle Medicine. 2015;9(3):185-211.

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Meditation experience in young adult cancer survivors	Meditation experience in young adult cancer survivors will be assessed using the Meditation Experience Questionnaire, a local questionnaire developed by the study researchers.; Participants will report on their experience and familiarity with meditation concepts and practices. The measure uses Yes-No response options (1=Yes; 0=No). The minimum value one can score is 0, and the maximum is 5. The higher scores represent better outcome.	pre-intervention
Other	Treatment expectancy in young adult cancer survivors	Treatment expectancy in young adult cancer survivors will be assessed using the HEAL 6-Item Treatment Expectancy Subscale, a local questionnaire developed by the study researchers.; Participants will report on the expectations they have about the outcomes of the study treatment. Each scale measure uses a 5-point Likert scale (1=not at all to 5=very much). The higher scores represent better outcome.	pre-intervention
Other	Socio-demographic and clinical factors in mindfulness program participation	Socio-demographic and clinical factors in mindfulness program participation in young adult cancer survivors will be assessed using the Socio-Demographic and Clinical Information Questionnaire., a local questionnaire developed by the study researchers.; Participants will report on the following: age; sex; gender identity; relationship status; living status; education; employment; income; current/past health history; current/past cancer history and treatment.	pre-intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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