Clinical trial NCT03078608: POEM (Practice Of Embracing Each Moment) STUDY
Official title: A Pilot Study of a Mobile/Online-based Mindfulness Intervention for Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Cancer
Chemotherapy Effect
Keywords: anxiety
quality of life
mindfulness
meditation
depression
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-03-13
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Anxiety--patients
timeFrame: Baseline to 8 weeks
measure: Change in Depression--patients
timeFrame: Baseline to 8 weeks
measure: Change in Anxiety--caregivers
timeFrame: Baseline to 8 weeks
measure: Change in Depression--caregivers
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in Distress--patients
timeFrame: Baseline to 8 weeks
measure: Change in Fatigue--patients
timeFrame: Baseline to 8 weeks
measure: Change in Pain Interference--patients
timeFrame: Baseline to 8 weeks
measure: Change in Distress--caregivers
timeFrame: Baseline to 8 weeks
measure: Change in Fatigue--caregivers
timeFrame: Baseline to 8 weeks
measure: Change in Pain Interference--caregivers
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente Northern California, Division of Research
name: Ai Kubo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.