POEM (Practice Of Embracing Each Moment) STUDY

NCT03078608 | Completed Results DMC

• 1 other identifier: CN-17-2851
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

anxiety; quality of life; mindfulness; meditation; depression

Outcome Measures

Primary Outcomes (4)

• Change in Anxiety--patients

  The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety in patient-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.

  Baseline to 8 weeks

• Change in Depression--patients

  The Hospital Anxiety and Depression Scale (HADS) will be used to measure depression in patients. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.

  Baseline to 8 weeks

• Change in Anxiety--caregivers

  The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety in caregiver-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.

  Baseline to 8 weeks

• Change in Depression--caregivers

  The Hospital Anxiety and Depression Scale (HADS) will be used to measure depression in caregiver-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.

  Baseline to 8 weeks

Secondary Outcomes (6)

• Change in Distress--patients

  Baseline to 8 weeks

• Change in Fatigue--patients

  Baseline to 8 weeks

• Change in Pain Interference--patients

  Baseline to 8 weeks

• Change in Distress--caregivers

  Baseline to 8 weeks

• Change in Fatigue--caregivers

  Baseline to 8 weeks

Study Arms (3)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Mindfulness meditation program (administered via mobile app)

Active control arm

ACTIVE COMPARATOR

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.

Behavioral: Progressive muscle relaxation (via mobile app)

Wait list control arm

OTHER

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).

Behavioral: Mindfulness meditation program (administered via mobile app)

Interventions

Mindfulness meditation program (administered via mobile app) BEHAVIORAL

Mobile app-based/online mindfulness meditation program

Intervention arm; Wait list control arm

Progressive muscle relaxation (via mobile app) BEHAVIORAL

Mobile app-based/online progressive muscle relaxation program

Active control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94611, United States

Location

Related Publications (1)

• 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.

  PMID: 31092044 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Elaine Kurtovich
• Organization: Kaiser Permanente Northern California

elaine.m.kurtovich@kp.org

510-891-3118

Study Officials

• Ai Kubo, PhD

  Kaiser Permanente Northern California, Division of Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 13, 2017
• Study Start: October 24, 2017
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)