- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03751995
POEM (Practice of Embracing Each Moment) Study (Delivery Science)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Oakland, California, United States, 94611
- Kaiser Permanente Northern California
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smartphone or tablet ownership OR has a computer with internet access
- Ability to read and understand English
- Patients: current Kaiser Permanente member with diagnosis of cancer and receiving palliative or supportive therapy at one of the participating oncology clinics
- Caregivers: primary unpaid support person of the patient who takes care of the patient at least two hours a week.
Exclusion Criteria:
- Severe hearing impairment
- Severe mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participants from medical centers assigned to the control arm will receive usual care.
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Experimental: Intervention
Participants from medical centers assigned to the intervention arm will receive access to their choice of a mindfulness app or a webinar-based mindfulness course for 6 weeks.
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Participants in the intervention group will have their choice of two commercially available mindfulness programs, HeadspaceTM and eMindful for 6 weeks. The Headspace program provides progressive guided mindfulness meditation instruction via a website and mobile app to help users learn the skills of mindfulness for use in everyday life. Sessions last 3-20 minutes. Videos encourage the integration of mindfulness into daily life. eMindful offers an online virtual classroom where participants can participate in synchronous, 1-hour mindfulness classes 1-2 times per week. The program is modeled after the mindfulness-based stress reduction (MBSR) program. eMindful also offers a cancer-specific meditation course that participants may choose to participate in. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hospital Anxiety and Depression Scale
Time Frame: Baseline to 6 weeks
|
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression.
Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
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Baseline to 6 weeks
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Change in Hospital Anxiety and Depression Scale
Time Frame: Baseline to 12 weeks
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The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression.
Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
|
Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
Time Frame: Baseline to 6 weeks
|
The 46-item Functional Assessment of Chronic Illness Therapy-Palliative care questionnaire assesses health-related quality of life for patients receiving palliative care.
It includes subscales for physical, social, emotional and functional well-being as well as a fifth subscale for additional item relevant to quality of life for persons with advanced or life-limiting illness.
Scores are calculated by summing the scores from the individual items for the overall score or from the individual items in each subscale for the subscale scores.
The score can range from 0 to 184 for the overall scale, 0-76 for the palliative care items, 0-28 for the physical, social, and functional well-being subscales, and 0-24 for the emotional well-being subscale.
Higher scores indicate better quality of life.
|
Baseline to 6 weeks
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Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
Time Frame: Baseline to 12 weeks
|
The 46-item Functional Assessment of Chronic Illness Therapy-Palliative care questionnaire assesses health-related quality of life for patients receiving palliative care.
It includes subscales for physical, social, emotional and functional well-being as well as a fifth subscale for additional item relevant to quality of life for persons with advanced or life-limiting illness.
Scores are calculated by summing the scores from the individual items for the overall score or from the individual items in each subscale for the subscale scores.
The score can range from 0 to 184 for the overall scale, 0-76 for the palliative care items, 0-28 for the physical, social, and functional well-being subscales, and 0-24 for the emotional well-being subscale.
Higher scores indicate better quality of life.
|
Baseline to 12 weeks
|
Change in Brief COPE coping strategy questionnaire (patients only)
Time Frame: Baseline to 6 weeks
|
The Brief COPE is a 28-item questionnaire that measures coping strategies.
There are 14 scales with 2 items each: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame.
Items are summed to produce scale scores (possible range: 2-8), with higher scores reflecting greater use of a particular coping strategy.
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Baseline to 6 weeks
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Change in Brief COPE coping strategy questionnaire (patients only)
Time Frame: Baseline to 12 weeks
|
The Brief COPE is a 28-item questionnaire that measures coping strategies.
There are 14 scales with 2 items each: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame.
Items are summed to produce scale scores (possible range: 2-8), with higher scores reflecting greater use of a particular coping strategy.
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Baseline to 12 weeks
|
Change in Post-Traumatic Growth Inventory
Time Frame: Baseline to 6 weeks
|
The 21-item Posttraumatic Growth Inventory (PTGI) assesses five factors of posttraumatic growth (positive change experienced because of a traumatic event or crisis): relating to others (7 items), new possibilities (5 items), personal strength (4 items), spiritual change (2 items), and appreciation of life (3 items).
Respondents are asked to rate to what extent they have seen the listed changes as a result as a crisis in their lives.
The PTGI is scored by adding all the responses (score range: 0-105).
Individual factors are scored by adding responses to items on each factor (score range: 0-(number of items x 5)).
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Baseline to 6 weeks
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Change in Post-Traumatic Growth Inventory
Time Frame: Baseline to 12 weeks
|
The 21-item Posttraumatic Growth Inventory (PTGI) assesses five factors of posttraumatic growth (positive change experienced because of a traumatic event or crisis): relating to others (7 items), new possibilities (5 items), personal strength (4 items), spiritual change (2 items), and appreciation of life (3 items).
Respondents are asked to rate to what extent they have seen the listed changes as a result as a crisis in their lives.
The PTGI is scored by adding all the responses (score range: 0-105).
Individual factors are scored by adding responses to items on each factor (score range: 0-(number of items x 5)).
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Baseline to 12 weeks
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Change in Five Facet Mindfulness Questionnaire
Time Frame: Baseline to 6 weeks
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The 24-item Five Facet Mindfulness Questionnaire (short form) (FFMQ) measures five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Factor subscale scores are calculated by summing individual items scores and range from 5-25 except for the 'observing' subscale, which ranges 4-20.
Higher scores indicate greater mindfulness.
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Baseline to 6 weeks
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Change in Five Facet Mindfulness Questionnaire
Time Frame: Baseline to 12 weeks
|
The 24-item Five Facet Mindfulness Questionnaire (short form) (FFMQ) measures five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Factor subscale scores are calculated by summing individual items scores and range from 5-25 except for the 'observing' subscale, which ranges 4-20.
Higher scores indicate greater mindfulness.
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Baseline to 12 weeks
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Change in Caregiver Quality of Life-Cancer scale (caregivers only)
Time Frame: Baseline to 6 weeks
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The Caregiver Quality of Life Index - Cancer (CQOLC) 35-item scale gauges the daily and overall impact caregiving has on respondents' quality of life.
The overall score is calculated by summing all items, and possible scores range 0-140.
Higher scores indicate better quality of life.
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Baseline to 6 weeks
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Change in Caregiver Quality of Life-Cancer scale (caregivers only)
Time Frame: Baseline to 12 weeks
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The Caregiver Quality of Life Index - Cancer (CQOLC) 35-item scale gauges the daily and overall impact caregiving has on respondents' quality of life.
The overall score is calculated by summing all items, and possible scores range 0-140.
Higher scores indicate better quality of life.
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Baseline to 12 weeks
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Change in PROMIS pain interference scale (caregivers only)
Time Frame: Baseline to 6 weeks
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The 9-item PROMIS Pain Interference scale assesses pain level and extent to which pain interfered with functional activities during the past 7 days.
The pain base score is based on one item and scores range 0-10.
The pain interference is calculated by summing the remaining 8 items and scores range 8-40.
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Baseline to 6 weeks
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Change in PROMIS pain interference scale (caregivers only)
Time Frame: Baseline to 12 weeks
|
The 9-item PROMIS Pain Interference scale assesses pain level and extent to which pain interfered with functional activities during the past 7 days.
The pain base score is based on one item and scores range 0-10.
The pain interference is calculated by summing the remaining 8 items and scores range 8-40.
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Baseline to 12 weeks
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Change in PROMIS sleep disturbance scale (caregivers only)
Time Frame: Baseline to 6 weeks
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The 8-item PROMIS Sleep Disturbance scale assesses sleep disturbance during the past 7 days.
A higher summary score, calculated by summing scores from individual items, indicates worse sleep disturbance.
Possible scores range from 8-40.
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Baseline to 6 weeks
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Change in PROMIS sleep disturbance scale (caregivers only)
Time Frame: Baseline to 12 weeks
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The 8-item PROMIS Sleep Disturbance scale assesses sleep disturbance during the past 7 days.
A higher summary score, calculated by summing scores from individual items, indicates worse sleep disturbance.
Possible scores range from 8-40.
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Baseline to 12 weeks
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Change in Brief Fatigue Inventory (caregivers only)
Time Frame: Baseline to 6 weeks
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The 9-item Brief Fatigue Inventory (BFI) assesses the severity and impact of fatigue and the extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood) on a 10-point Likert scale.
A global fatigue score can be obtained by averaging all the items on the BFI (score range: 0-10).
Higher scores on the BFI correspond to greater self-reported levels of fatigue.
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Baseline to 6 weeks
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Change in Brief Fatigue Inventory (caregivers only)
Time Frame: Baseline to 12 weeks
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The 9-item Brief Fatigue Inventory (BFI) assesses the severity and impact of fatigue and the extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood) on a 10-point Likert scale.
A global fatigue score can be obtained by averaging all the items on the BFI (score range: 0-10).
Higher scores on the BFI correspond to greater self-reported levels of fatigue.
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Baseline to 12 weeks
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Change in Distress Thermometer
Time Frame: Baseline to 6 weeks
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The National Comprehensive Cancer Network Distress Thermometer assesses current distress level.
Respondents are asked to rate their level of distress during the past week by choosing a number, with 0 indicating no distress and 10 extreme distress.
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Baseline to 6 weeks
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Change in Distress Thermometer
Time Frame: Baseline to 12 weeks
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The National Comprehensive Cancer Network Distress Thermometer assesses current distress level.
Respondents are asked to rate their level of distress during the past week by choosing a number, with 0 indicating no distress and 10 extreme distress.
|
Baseline to 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ai Kubo, PhD, Kaiser Permanente
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-18-3183
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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