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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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.
interventionNames
Behavioral: Wakeful Spanish
Primary outcomes (6)
measure
Implementation feasibility measured by enrollment rate
timeFrame
continuously for 9 weeks
description
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.
measure
Implementation feasibility measured by retention rate
timeFrame
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Maximum age
39 Years
Show eligibility criteria text
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
References
Publications (32)
BACKGROUNDRabin 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. PMID 26812450
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BACKGROUNDRuffault 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. PMID 27658995
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continuously for 9 weeks
description
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.
measure
Implementation feasibility measured by completion rate
timeFrame
continuously for 9 weeks
description
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.
measure
Acceptability of the Wakeful program as measured by a post-intervention evaluation survey
timeFrame
post-intervention
description
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.
measure
Acceptability of the Wakeful program as measured by mindfulness reflections
timeFrame
continuously for 9 weeks
description
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.
measure
Adherence to the Wakeful program
timeFrame
continuously for 9 weeks
description
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
Secondary outcomes (6)
measure
Change in mindful self-compassion
timeFrame
pre-intervention; post intervention
description
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.
measure
Change in symptom burden of anxiety
timeFrame
pre-intervention; post intervention
description
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.
measure
Change in symptom burden of depression
timeFrame
pre-intervention; post intervention
description
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.
measure
Change in perceived stress
timeFrame
pre-intervention; post intervention
description
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.
measure
Change in health behaviors
timeFrame
pre-intervention; post intervention
description
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.
measure
Change in leisure time physical activity
timeFrame
pre-intervention; post intervention
description
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.
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