Mindfulness App for Cancer

(MenteCalma Trial)

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a Spanish mindfulness app called Wakeful for young adult cancer patients in Colombia. The app guides users through exercises to help them focus and relax over several weeks. Researchers want to see if the app is easy to use and if it helps improve the patients' well-being.

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 data supports the effectiveness of the treatment Wakeful Spanish in the Mindfulness App for Cancer trial?

Research shows that mindfulness-based therapies, including those delivered via mobile apps, can help improve quality of life and reduce distress in cancer patients. Studies have found these interventions to be feasible and beneficial for both patients and caregivers. ^{1 2 3 4 5}

Is the Mindfulness App for Cancer safe for humans?

The research on mindfulness apps, including those for cancer patients, suggests they are generally safe for humans. These studies focus on improving quality of life and reducing stress, with no significant safety concerns reported. ^{1 2 3 4 6}

How does the mindfulness app treatment for cancer differ from other treatments?

The mindfulness app treatment is unique because it uses a mobile application to deliver mindfulness-based stress reduction, which can help reduce anxiety, depression, and sleep disturbances in cancer patients. Unlike traditional treatments that may require in-person sessions, this app allows patients to practice mindfulness conveniently at home, making it more accessible and flexible. ^{2 6 7 8 9}

Research Team

Siobhan M Phillips, PhD, MPH

Principal Investigator

Northwestern University

David E Victorson, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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 have been diagnosed with cancer.

I am between 18 and 39 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System. [2020]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]

4. Scotland pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. [2008]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Spain pubmed.ncbi.nlm.nih.gov

Mindfulness based intervention through mobile app for colorectal cancer people awaiting surgery: A randomized clinical trial. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Rapid deployment of virtual mind-body interventions during the COVID-19 outbreak: feasibility, acceptability, and implications for future care. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. [2023]