Mindfulness App for Cancer

(MenteCalma Trial)

No longer recruiting at 1 trial location

Overseen By Bruriah E Horowitz, MEd

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Bedridden, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a Spanish-language mindfulness app, called Wakeful, can help young adults with cancer manage stress. The app provides a 9-week digital mindfulness course similar to traditional stress reduction programs. Suitable participants include those aged 18–39 who are fluent in Spanish, have a cancer diagnosis, are either undergoing treatment or completed primary treatment within the last three years, and have access to a device with internet. As an unphased trial, this study presents a unique opportunity to explore innovative stress management techniques tailored for Spanish-speaking young adults with cancer.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Wakeful Spanish app is safe for cancer patients?

Research shows that mindfulness apps like Wakeful are generally safe. Studies on similar apps, especially those used by cancer patients, indicate they are well-tolerated. These apps aim to improve quality of life without causing harm, and no major reports of negative effects have emerged.

Wakeful, the app being tested, is a Spanish-language version of a popular mindfulness course. It closely follows traditional mindfulness programs, which have a strong safety record. Previous research found that meditation apps designed for cancer patients are not only safe but also practical.

Overall, based on current research about similar mindfulness tools, the Wakeful app appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard cancer treatments, which often focus on medical interventions like chemotherapy or radiation, the Wakeful Spanish app offers a digital mindfulness course specifically designed for Spanish-speaking patients. This self-directed program is modeled after the well-established Mindfulness-based Stress Reduction (MBSR), but with the added benefit of being accessible anytime, anywhere via a smartphone, making it highly convenient. Researchers are excited about its potential to reduce stress and improve the quality of life for cancer patients without the side effects associated with traditional treatments.

What evidence suggests that the Wakeful Spanish app is effective for cancer patients?

Research shows that mindfulness programs can greatly improve the quality of life for cancer patients. Studies on the Wakeful app found that participants who completed the program experienced significant improvements in mindfulness and overall well-being related to their illness. This trial will evaluate Wakeful Spanish, the Spanish-language version of the app, which offers a self-guided, 9-week digital mindfulness course similar to traditional programs that reduce stress. Mindfulness practices are widely recommended for cancer patients because they help manage stress and boost emotional health. Early results suggest that Wakeful Spanish is both practical and well-received by Spanish-speaking cancer patients. ^{1 5 6 7 8}

Who Is on the Research Team?

David E Victorson, PhD

Principal Investigator

Northwestern University

Siobhan M Phillips, PhD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-39 who have been diagnosed with cancer and are currently undergoing treatment or have completed it within the last three years. Participants must be fluent in Spanish, able to provide informed consent, and have access to a Wi-Fi-enabled device like a smartphone.

Inclusion Criteria

I am currently undergoing or finished my main cancer treatment within the last 3 years.

Fluency in spoken and written Spanish

Access to a device with Wifi (e.g., smartphone, computer, tablet)

Exclusion Criteria

I am not bedridden and can participate in the study without undue hardship.

Inability to provide informed consent

Prisoners or other detained individuals at time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Orientation

Participants receive an email invitation to participate in a Wakeful orientation via Zoom, where they register and begin the 9-week self-directed course

1 week

1 virtual visit (Zoom)

Treatment

Participants engage in a 9-week self-directed digital mindfulness course using the Wakeful app

9 weeks

Follow-up

Participants are monitored for acceptability and satisfaction metrics, and have access to app features for continued practice

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wakeful Spanish

Trial Overview The study is testing the 'Wakeful' app, which offers mindfulness education in Spanish over nine weeks. It aims to assess how feasible and acceptable this eHealth tool is among Colombian young adult cancer patients as part of an international research partnership.

How Is the Trial Designed?

Group I: Wakeful Spanish Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Hospital Universitario San Ignacio Pontificia Universidad Jveriana

Collaborator

Trials

1

Recruited

50+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

An 8-week mindfulness treatment delivered through an app was feasible for some patients with brain tumors, with 20 participants starting the study, but only 10 completed it, highlighting challenges in recruitment and retention.

Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in social/family quality of life, indicating the need for further research to optimize engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. De Tommasi, C., Richardson, E., Reale, M., et al.[2021]

Mindfulness-based stress reduction training significantly improved quality of life and reduced physical symptoms in 47 cancer patients, with benefits observed immediately after training and even stronger effects reported one year later.

Participants experienced decreased mood disturbances, such as depression and anger, indicating that mindfulness training can help cancer patients manage stress and enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. Kieviet-Stijnen, A., Visser, A., Garssen, B., et al.[2008]

Women with breast cancer who used a mobile app for mindfulness training reported significantly higher quality of life compared to those in the waitlist control group over an 8-week period.

The mindfulness training also led to increased dispositional mindfulness in participants, indicating that the app may help improve mental well-being alongside physical health after a breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. Rosen, KD., Paniagua, SM., Kazanis, W., et al.[2022]

The Being Present audio-based mindfulness meditation program, tested over 8 weeks with 53 participants (33 patients and 20 caregivers), showed significant reductions in distress and anxiety levels among patients with metastatic colorectal cancer and their caregivers.

Participants reported high adherence to the program, with 59% practicing mindfulness regularly, and 79% expressed intentions to continue practicing after the study, indicating the program's feasibility and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. Atreya, CE., Kubo, A., Borno, HT., et al.[2023]

Mindfulness-based therapy (MBT) significantly reduces anxiety, depression, fear of recurrence, and fatigue in breast cancer patients, based on a meta-analysis of seven studies involving 951 participants.

MBT also improves emotional well-being, physical function, and physical health in these patients, suggesting it could be a valuable complementary treatment alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. Zhang, J., Xu, R., Wang, B., et al.[2022]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

The study evaluated the effectiveness of a mindfulness-based stress reduction app in reducing anxiety and depression symptoms among colorectal cancer patients, but found no significant changes between the intervention and control groups.

Despite a slight trend towards reduced anxiety and depression in the intervention group, the overall low levels of these symptoms at baseline and the high average age of participants (65 years) may have limited the app's effectiveness, suggesting future studies should target younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness based intervention through mobile app for colorectal cancer people awaiting surgery: A randomized clinical trial. Rocamora González, C., Rodríguez Vega, B., Torrijos Zarcero, M., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-malignancies-7-2023-f40ed

Mindfulness App for Cancer (MenteCalma Trial) Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in ...

2. clinicaltrial.be clinicaltrial.be/en/details/271383?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Meditation, Education, Navigation, & Training Using eHeal... Wakeful Spanish is the Spanish-language version of Wakeful, a self-directed 9-week digital mindfulness course closely aligned with traditional 8 ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05912166

Wakeful Spanish in Cancer - Clinical Trials Registry - ICH GCP Acceptability of the Wakeful program as measured by mindfulness reflections written by participants in the Wakeful app will be collected ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12460520/

Benefits of a mindfulness and compassion program for ... Mindfulness-based interventions have been shown to improve the quality of life of cancer patients and are widely recommended.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04184557

Effectiveness of a Mindfulness Smartphone App to Reduce ... This study focuses on people with a recent diagnosis of cancer who have been scheduled for surgery. Evidence suggests that around 11% of people with cancer ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05912166

Study Details | NCT05912166 | Meditation, Education, ... Evaluate the implementation feasibility and acceptability of the 9-week Spanish-translated mindfulness app, Wakeful, in a mixed Colombian young adult cancer ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9730204/

Meditation Mobile App Developed for Patients With and ... This study established the feasibility of a cancer-specific mobile meditation app prototype for patients with and survivors of cancer, using a commercially ...

8. formative.jmir.org formative.jmir.org/2022/1/e32458/

Leveraging a Consumer-Based Product to Develop a Cancer ... Cancer-specific meditation apps are needed to ensure clinical acceptability, effectiveness, and safety for patients/survivors. Research shows ...