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Mindfulness App for Cancer (MenteCalma Trial)

N/A

Recruiting

Led By David E Victorson, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention

Awards & highlights

MenteCalma Trial Summary

This trial aims to improve care for young adult cancer patients in Colombia by testing a mindfulness app & translating content to Spanish.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves using a mindfulness app, there are no direct medical side effects expected. However, participants may experience emotional discomfort when engaging with mindfulness practices.

MenteCalma Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously for 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuously for 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously for 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the Wakeful program as measured by a post-intervention evaluation survey

Acceptability of the Wakeful program as measured by mindfulness reflections

Adherence to the Wakeful program

+3 more

Secondary outcome measures

Change in health behaviors

Change in leisure time physical activity

Change in mindful self-compassion

+3 more

Other outcome measures

Meditation experience in young adult cancer survivors

Socio-demographic and clinical factors in mindfulness program participation

Treatment expectancy in young adult cancer survivors

MenteCalma Trial Design

1Treatment groups

Experimental Treatment

Group I: Wakeful SpanishExperimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital Universitario San Ignacio Pontificia Universidad JverianaUNKNOWN

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,057 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,411 Total Patients Enrolled

Media Library

Wakeful Spanish Clinical Trial Eligibility Overview. Trial Name: NCT05912166 — N/A

Cancer Research Study Groups: Wakeful Spanish

Cancer Clinical Trial 2023: Wakeful Spanish Highlights & Side Effects. Trial Name: NCT05912166 — N/A

Wakeful Spanish 2023 Treatment Timeline for Medical Study. Trial Name: NCT05912166 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study accept participants of all ages, including those over 35?

"This trial necessitates that participants are aged 18 to 39. There is a total of 68 studies for those under the legal age and 468 for patients over 65 years old."

Answered by AI

Are there current opportunities to participate in this experiment?

"According to data published on clinicaltrials.gov, recruitment for this trial has been concluded. While the study was first posted on August 1st 2023 and last updated June 12th 2023, there are currently 528 other trials seeking participants."

Answered by AI

Who would be most likely to benefit from participating in this trial?

"To be considered for this research project, applicants must have cancer and fit within the 18 to 39 year old age bracket. Currently, there are room for approximately 30 participants."

Answered by AI

What results is this experiment hoping to yield?

"The primary end-point of this nine week trial is the feasibility rate, which will be assessed by patient retention. Secondary objectives include evaluating symptom burden for depression via a 4-item PROMIS scale with scores ranging from four to twenty; measuring mindful self-compassion using the Self Compassion Scale (SCS) - 12 items scored on 1 to 5 Likert scales; and gauging perceived stress levels through a 10 item Perceived Stress Scale (PSS)."

Answered by AI

Recent research and studies

Journal of Adolescent and Young Adult OncologyJournal

Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors

Rabin, Carolyn, Bernardine Pinto, and Joseph Fava. 2016. “Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors”. Journal of Adolescent and Young Adult Oncology. Mary Ann Liebert Inc. doi:10.1089/jayao.2015.0033.

Obesity ReviewsJournal

The Role of Mindfulness in Physical Activity: A Systematic Review

Schneider, J., P. Malinowski, P. M. Watson, and P. Lattimore. 2018. “The Role of Mindfulness in Physical Activity: A Systematic Review”. Obesity Reviews. Wiley. doi:10.1111/obr.12795.

Psycho-OncologyJournal

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

Victorson, David, Vered Hankin, James Burns, Rebecca Weiland, Carly Maletich, Nathaniel Sufrin, Stephanie Schuette, Bruriah Gutierrez, and Charles Brendler. 2016. “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”. Psycho-oncology. Wiley. doi:10.1002/pon.4135.

clinicaltrials.govStudy