POEM (Practice Of Embracing Each Moment) STUDY

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of a Mobile/Online-based Mindfulness Intervention for Cancer Patients and Caregivers

Conditions
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Cancer, Distress, Chemotherapy Effect

Intervention / Treatment
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* Behavioral: Mindfulness meditation program (administered via mobile app)
* Behavioral: Progressive muscle relaxation (via mobile app)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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)<br>* Mobile app-based/online mindfulness meditation program<br>|
| Active Comparator: Active control arm<br>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)<br>* Mobile app-based/online progressive muscle relaxation program<br>|
| Other: Wait list control arm<br>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)<br>* Mobile app-based/online mindfulness meditation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety and depression | The Hospital Anxiety and Depression Scale (HADS) will be used to measure both anxiety and depression. 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 and depression | The Hospital Anxiety and Depression Scale (HADS) will be used to measure both anxiety and depression. 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 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distress | The National Comprehensive Cancer Network Distress Thermometer will be used to assess current distress level. Respondents are asked to rate their level of distress during the past week by circling a number on an image of a thermometer, with 0 indicating no distress and 10 extreme distress. | Baseline to 8 weeks | 
| Change in distress | The National Comprehensive Cancer Network Distress Thermometer will be used to assess current distress level. Respondents are asked to rate their level of distress during the past week by circling a number on an image of a thermometer, with 0 indicating no distress and 10 extreme distress. | Baseline to 16 weeks | 
| Change in fatigue | The Brief Fatigue Inventory assesses the severity and impact of cancer-related fatigue, asks about current level of fatigue, average and worst level of fatigue in the past 24 hours, and extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood, walking ability) on a 10-point Likert scale. A global fatigue score is calculated by averaging all items (ranging from 0 to 10). A higher score represents greater severity and impact of fatigue. | Baseline to 8 weeks | 
| Change in fatigue | The Brief Fatigue Inventory assesses the severity and impact of cancer-related fatigue, asks about current level of fatigue, average and worst level of fatigue in the past 24 hours, and extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood, walking ability) on a 10-point Likert scale. A global fatigue score is calculated by averaging all items (ranging from 0 to 10). A higher score represents greater severity and impact of fatigue. | Baseline to 16 weeks | 
| Change in Pain | The Patient-Reported Outcomes Measurement Information System(PROMIS) pain scale will be used to measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. | Baseline to 8 weeks | 
| Change in Pain | The Patient-Reported Outcomes Measurement Information System(PROMIS) pain scale will be used to measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. | Baseline to 16 weeks | 
| Change in sleep quality | The Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep-Related Impairment scale measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. | Baseline to 8 weeks | 
| Change in sleep quality | The Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep-Related Impairment scale measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. | Baseline to 16 weeks | 
| Change in mindfulness | Mindfulness will be measured using the Five Facet Mindfulness Questionnaire | Baseline to 8 weeks | 
| Change in mindfulness | Mindfulness will be measured using the Five Facet Mindfulness Questionnaire | Baseline to 16 weeks | 
| Change in Post Traumatic Growth | Self-reported posttraumatic growth as a result of having cancer will be measured using the Post Traumatic Growth Inventory. | Baseline to 8 weeks | 
| Change in Post Traumatic Growth | Self-reported posttraumatic growth as a result of having cancer will be measured using the Post Traumatic Growth Inventory. | Baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, quality of life, mindfulness, meditation, depression