POEM (Practice Of Embracing Each Moment) STUDY

NCT ID: NCT03078608

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2018-11-08

Brief Summary

A cancer diagnosis is extremely stressful, emotionally challenging, and often life-altering for both patients and their loved ones. Although more than one-third of patients experience distress, doctors are typically at a loss as to how to help patients and their families manage these emotional challenges. Mindfulness-based programs, including meditation, are offered at major medical centers in the US and have been found to help reduce stress and improve quality of life among cancer patients. However, these classes often require 30+ hours of in-person instruction over 8 weeks, which is neither practical nor feasible for patients undergoing chemotherapy due to side effects and scheduling conflicts.

This study will test whether an 8-week mobile app-based mindfulness program is accepted and useful for patients who have recently received chemotherapy and their loved ones. It will also test whether it is feasible to randomize participants into three groups: intervention, active control (receiving progressive muscle relaxation through the same app) and a wait list control group (will receive the meditation intervention 8 weeks later), so that a future study can test whether mindfulness intervention can help reduce stress and improve quality of life. Because many Americans own smartphone or tablet, an app that can teach stress reduction techniques at home or at infusion clinics has great potential to address emotional needs that providers often cannot.

The study will also include caregivers of patients who have recently received chemotherapy as research has shown that caregivers tend to show high levels of stress and depression and worse physical health compared to non-caregivers. The negative effects of caregiving are most pronounced in caregivers of patients with cancer. However, little support is directed to caregivers as most medical attention goes toward the patients. The patient-caregiver relationship may serve as a source of mutual support and a surrogate for community, which is traditionally considered to be an essential ingredient for sustaining mindfulness practices.

If this study is successful, it will justify a larger trial to determine if use of a mindfulness app is effective in reducing stress and improving quality of life for cancer patients and caregivers. If effective, this low-cost stress reduction strategy could be distributed and used for all types and stages of cancer patients and their caregivers, anywhere, any time, helping to improve the quality of life of the many individuals affected by cancer.

Conditions

Distress; Cancer; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

Participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.

Group Type: EXPERIMENTAL

Mindfulness meditation program (administered via mobile app)

Intervention Type: BEHAVIORAL

Mobile app-based/online mindfulness meditation program

Active control arm

Participants in this arm will receive access to a mobile app-based/online progressive muscle relaxation (PMR) program and asked to practice PMR daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Progressive muscle relaxation (via mobile app)

Intervention Type: BEHAVIORAL

Mobile app-based/online progressive muscle relaxation program

Wait list control arm

Participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).

Group Type: OTHER

Mindfulness meditation program (administered via mobile app)

Intervention Type: BEHAVIORAL

Mobile app-based/online mindfulness meditation program

Interventions

Mindfulness meditation program (administered via mobile app)

Mobile app-based/online mindfulness meditation program

Intervention Type: BEHAVIORAL

Progressive muscle relaxation (via mobile app)

Mobile app-based/online progressive muscle relaxation program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• active member of Kaiser Permanente Northern California
• a diagnosis of cancer, and currently undergoing chemotherapy or completed chemotherapy in the past 6 months at time of recruitment
• English literacy/fluency, access to a smartphone, a tablet (e.g., iPad) or a computer with internet
• Caregivers: a partner, other family member, or a close friend who identify him/herself as the patient's primary unpaid caregiver. English literacy/fluency, access to a smartphone, a tablet (e.g., iPad) or a computer with internet access

Exclusion Criteria

• Deafness
• severe mental illness
• Hospital Anxiety and Depression Scale score <8 or >14 on either anxiety or depression scale (patient only)
• current stress reduction practice

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ai Kubo, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northern California, Division of Research

Locations

Kaiser Permanente Northern California

Oakland, California, United States

Countries

United States

References

Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Avins AL. 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. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419850634. doi: 10.1177/1534735419850634.

Reference Type: BACKGROUND

PMID: 31092044 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CN-17-2851

Identifier Type: -

Identifier Source: org_study_id