What side effects are associated with this type of intervention?

Common treatments for cancer include chemotherapy, radiation therapy, surgery, and targeted therapy, each with its own set of side effects. Chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and localized pain. Surgery carries risks of pain, infection, and recovery-related complications. Targeted therapy can result in skin problems, high blood pressure, and gastrointestinal issues. Mindfulness practices, such as those studied in the Wakeful trial, are generally safe and aim to reduce stress and improve mental well-being, with minimal side effects like temporary discomfort during meditation or emotional release.

What prior FDA approvals exist?

The FDA has approved various drugs for the treatment of cancer, including chemotherapeutic agents, targeted therapies, and immunotherapies. While mindfulness practices such as those studied in the Wakeful trial (aimed at reducing stress and improving mental well-being) are not FDA-approved treatments, they are increasingly being studied as complementary therapies. These practices, including yoga, Qigong, and mindfulness-based stress reduction, have shown potential benefits in improving quality of life and mental well-being in cancer patients.

What other types of research exist?

Promising alternatives to Wakeful for cancer patients include: 1) Cognitive Behavioral Therapy (CBT), which has shown effectiveness in managing stress and improving mental well-being. 2) Yoga, which has been recommended for its benefits in reducing anxiety, stress, and improving mood. 3) Hypnosis, particularly for procedure-related pain and stress management. 4) Tai Chi, which has demonstrated benefits in reducing cancer-related fatigue and improving quality of life. 5) Guided Imagery and Progressive Muscle Relaxation, which have been effective in reducing pain and stress in cancer patients.

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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 ~ pre-intervention; post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention; post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention; post intervention 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness practices, such as those studied in the Wakeful trial, work by promoting a state of focused, nonjudgmental awareness of the present moment. This can help cancer patients manage stress, anxiety, and depression, which are common during cancer treatment. By reducing psychological distress, mindfulness can improve overall quality of life and potentially enhance the body's ability to cope with cancer. Other common cancer treatments include chemotherapy, which targets rapidly dividing cells; radiation therapy, which damages the DNA of cancer cells; and surgery, which physically removes tumors. These treatments directly target cancer cells, while mindfulness practices support mental and emotional health, making them a valuable complementary approach.

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control.Mindfulness meditation for younger breast cancer survivors: a randomized controlled trial.Comparison of the acceptability and benefits of two mindfulness-based interventions in women with breast or gynecologic cancer: a pilot study.

Find a Location

Who is running the clinical trial?

Hospital Universitario San Ignacio Pontificia Universidad JverianaUNKNOWN

Northwestern UniversityLead Sponsor

1,601 Previous Clinical Trials

915,629 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,719 Previous Clinical Trials

40,963,501 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

~6 spots leftby Jul 2024

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