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CancerMenteCalmaNCT05912166

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

A study testing Wakeful Spanish in people with Cancer, run by Northwestern University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer
What is being tested?
Wakeful Spanish
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesin 2 countries
Study dates
27 Feb 2024to 29 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

Colombia1 site

  • Hospital Universitario San Ignacio Pontificia Universidad Jveriana

    Bogotá, Capital District Cundinamarca, 110231

Other trials in Colombia

About this study

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.
Read the 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).

Conditions
Cancer
Being tested
Wakeful Spanish
Keywords
cancer, young adult, e-health, mindfulness, remote-delivered, Spanish-language, international, Colombia
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wakeful SpanishBehavioural

    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.
Study groups in NCT05912166
Study groupRoleWhat they receive
Wakeful SpanishExperimentalWakeful 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.
Receives: Behavioral: Wakeful Spanish

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: continuously for 9 weeks

  2. 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.

    Measured: continuously for 9 weeks

  3. 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.

    Measured: continuously for 9 weeks

  4. 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.

    Measured: post-intervention

  5. 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.

    Measured: continuously for 9 weeks

  6. 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

    Measured: continuously for 9 weeks

Secondary outcomes (6)

  1. 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.

    Measured: pre-intervention; post intervention

  2. 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.

    Measured: pre-intervention; post intervention

  3. 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.

    Measured: pre-intervention; post intervention

  4. 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.

    Measured: pre-intervention; post intervention

  5. 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.

    Measured: pre-intervention; post intervention

  6. 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.

    Measured: pre-intervention; post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start27 Feb 2024
  3. Primary completion29 Sep 2024
  4. Study completion29 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912166
Sponsor's protocol ID
NU 23CC02
Other IDs
3R01CA262357-02S1
Acronym
MenteCalma
Status last verified
Feb 2025
First submitted
12 Jun 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rabin C, Pinto B, Fava J. Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):41-7. doi: 10.1089/jayao.2015.0033. Epub 2015 Oct 15.

    PubMed 26812450

  • Meyer JD, Torres ER, Grabow ML, Zgierska AE, Teng HY, Coe CL, Barrett BP. Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. Med Sci Sports Exerc. 2018 Sep;50(9):1850-1858. doi: 10.1249/MSS.0000000000001636.

    PubMed 30113538

  • Lucas AR, Focht BC, Cohn DE, Buckworth J, Klatt MD. A Mindfulness-Based Lifestyle Intervention for Obese, Inactive Endometrial Cancer Survivors: A Feasibility Study. Integr Cancer Ther. 2017 Sep;16(3):263-275. doi: 10.1177/1534735416668257. Epub 2016 Sep 14.

    PubMed 27627985

  • Ruffault A, Czernichow S, Hagger MS, Ferrand M, Erichot N, Carette C, Boujut E, Flahault C. The effects of mindfulness training on weight-loss and health-related behaviours in adults with overweight and obesity: A systematic review and meta-analysis. Obes Res Clin Pract. 2017 Sep-Oct;11(5 Suppl 1):90-111. doi: 10.1016/j.orcp.2016.09.002. Epub 2016 Sep 19.

    PubMed 27658995

  • Chatzisarantis NL, Hagger MS. Mindfulness and the intention-behavior relationship within the theory of planned behavior. Pers Soc Psychol Bull. 2007 May;33(5):663-76. doi: 10.1177/0146167206297401. Epub 2007 Apr 17.

    PubMed 17440208

  • Ulmer CS, Stetson BA, Salmon PG. Mindfulness and acceptance are associated with exercise maintenance in YMCA exercisers. Behav Res Ther. 2010 Aug;48(8):805-9. doi: 10.1016/j.brat.2010.04.009. Epub 2010 May 21.

    PubMed 20488433

  • Arch JJ, Craske MG. Mechanisms of mindfulness: emotion regulation following a focused breathing induction. Behav Res Ther. 2006 Dec;44(12):1849-58. doi: 10.1016/j.brat.2005.12.007. Epub 2006 Feb 7.

    PubMed 16460668

  • Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.

    PubMed 7042457

  • Chambers R, Gullone E, Allen NB. Mindful emotion regulation: An integrative review. Clin Psychol Rev. 2009 Aug;29(6):560-72. doi: 10.1016/j.cpr.2009.06.005. Epub 2009 Jun 23.

    PubMed 19632752

  • Tsafou KE, De Ridder DT, van Ee R, Lacroix JP. Mindfulness and satisfaction in physical activity: A cross-sectional study in the Dutch population. J Health Psychol. 2016 Sep;21(9):1817-27. doi: 10.1177/1359105314567207. Epub 2015 Jan 28.

    PubMed 25631662

  • Sirois FM. A self-regulation resource model of self-compassion and health behavior intentions in emerging adults. Prev Med Rep. 2015 Mar 30;2:218-22. doi: 10.1016/j.pmedr.2015.03.006. eCollection 2015.

    PubMed 26844074

  • Mantzios M, Egan HH. On the Role of Self-compassion and Self-kindness in Weight Regulation and Health Behavior Change. Front Psychol. 2017 Feb 16;8:229. doi: 10.3389/fpsyg.2017.00229. eCollection 2017. No abstract available.

    PubMed 28261147

  • Schneider J, Malinowski P, Watson PM, Lattimore P. The role of mindfulness in physical activity: a systematic review. Obes Rev. 2019 Mar;20(3):448-463. doi: 10.1111/obr.12795. Epub 2018 Nov 23.

    PubMed 30468299

  • Hankin VV, Polster, R. Maximizing Acceptance and Enrollment in MBSR Randomized Controlled Trials with Older Men Diagnosed with Cancer. . Poster presented to the 8th Annual International Scientific Conference of Mindfulness in Medicine, Health Care, and Society Worcester, MA. 2010.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Wakeful Spanish in people with Cancer, run by Northwestern University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation feasibility measured by enrollment rate (time frame: continuously for 9 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912166, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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