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Trial Outcomes & Findings for POEM (Practice Of Embracing Each Moment) STUDY (NCT NCT03078608)

NCT ID: NCT03078608

Last Updated: 2025-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

Baseline to 8 weeks

Results posted on

2025-04-16

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Arm--PATIENTS
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Intervention Arm--CAREGIVERS
Caregiver-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--CAREGIVERS
Caregiver-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Overall Study
STARTED
54
43
17
14
Overall Study
COMPLETED
40
32
13
13
Overall Study
NOT COMPLETED
14
11
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Arm--PATIENTS
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Intervention Arm--CAREGIVERS
Caregiver-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--CAREGIVERS
Caregiver-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Overall Study
Death
1
2
0
0
Overall Study
Withdrawal by Subject
8
1
0
0
Overall Study
Lost to Follow-up
5
8
4
1

Baseline Characteristics

POEM (Practice Of Embracing Each Moment) STUDY

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Arm--PATIENTS
n=54 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=43 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Intervention Arm--CAREGIVERS
n=17 Participants
Caregiver-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--CAREGIVERS
n=14 Participants
Caregiver-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Total
n=128 Participants
Total of all reporting groups
Age, Continuous
59.3 years
STANDARD_DEVIATION 14.1 • n=39 Participants
56.7 years
STANDARD_DEVIATION 14.7 • n=41 Participants
57.1 years
STANDARD_DEVIATION 17.4 • n=35 Participants
58.2 years
STANDARD_DEVIATION 18.6 • n=31 Participants
58.0 years
STANDARD_DEVIATION 15.1 • n=146 Participants
Sex: Female, Male
Female
33 Participants
n=39 Participants
33 Participants
n=41 Participants
9 Participants
n=35 Participants
9 Participants
n=31 Participants
84 Participants
n=146 Participants
Sex: Female, Male
Male
21 Participants
n=39 Participants
10 Participants
n=41 Participants
8 Participants
n=35 Participants
5 Participants
n=31 Participants
44 Participants
n=146 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
Race (NIH/OMB)
Asian
4 Participants
n=39 Participants
3 Participants
n=41 Participants
0 Participants
n=35 Participants
2 Participants
n=31 Participants
9 Participants
n=146 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
1 Participants
n=31 Participants
7 Participants
n=146 Participants
Race (NIH/OMB)
White
36 Participants
n=39 Participants
27 Participants
n=41 Participants
15 Participants
n=35 Participants
9 Participants
n=31 Participants
87 Participants
n=146 Participants
Race (NIH/OMB)
More than one race
8 Participants
n=39 Participants
9 Participants
n=41 Participants
2 Participants
n=35 Participants
2 Participants
n=31 Participants
21 Participants
n=146 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=39 Participants
3 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
4 Participants
n=146 Participants
Race/Ethnicity, Customized
Race · White
36 Participants
n=39 Participants
27 Participants
n=41 Participants
15 Participants
n=35 Participants
9 Participants
n=31 Participants
87 Participants
n=146 Participants
Race/Ethnicity, Customized
Race · African American
5 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
1 Participants
n=31 Participants
7 Participants
n=146 Participants
Race/Ethnicity, Customized
Race · Asian
4 Participants
n=39 Participants
3 Participants
n=41 Participants
0 Participants
n=35 Participants
2 Participants
n=31 Participants
9 Participants
n=146 Participants
Race/Ethnicity, Customized
Race · Other
8 Participants
n=39 Participants
9 Participants
n=41 Participants
2 Participants
n=35 Participants
2 Participants
n=31 Participants
21 Participants
n=146 Participants
Race/Ethnicity, Customized
Race · Unknown/not reported
1 Participants
n=39 Participants
3 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
4 Participants
n=146 Participants
Education
Some college or less
18 Participants
n=39 Participants
19 Participants
n=41 Participants
6 Participants
n=35 Participants
5 Participants
n=31 Participants
48 Participants
n=146 Participants
Education
College graduate
15 Participants
n=39 Participants
18 Participants
n=41 Participants
6 Participants
n=35 Participants
4 Participants
n=31 Participants
43 Participants
n=146 Participants
Education
Postgraduate degree
20 Participants
n=39 Participants
6 Participants
n=41 Participants
5 Participants
n=35 Participants
5 Participants
n=31 Participants
36 Participants
n=146 Participants
Education
Missing
1 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
1 Participants
n=146 Participants
Income
Less than $75 000
11 Participants
n=39 Participants
21 Participants
n=41 Participants
2 Participants
n=35 Participants
3 Participants
n=31 Participants
37 Participants
n=146 Participants
Income
$75 000 to $99 999
7 Participants
n=39 Participants
5 Participants
n=41 Participants
3 Participants
n=35 Participants
3 Participants
n=31 Participants
18 Participants
n=146 Participants
Income
$100 000 to $149 999
18 Participants
n=39 Participants
8 Participants
n=41 Participants
5 Participants
n=35 Participants
1 Participants
n=31 Participants
32 Participants
n=146 Participants
Income
$150 000 or more
12 Participants
n=39 Participants
5 Participants
n=41 Participants
5 Participants
n=35 Participants
3 Participants
n=31 Participants
25 Participants
n=146 Participants
Income
Missing
6 Participants
n=39 Participants
4 Participants
n=41 Participants
2 Participants
n=35 Participants
4 Participants
n=31 Participants
16 Participants
n=146 Participants
Cancer type
Breast
13 Participants
n=39 Participants
15 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
28 Participants
n=146 Participants
Cancer type
Hematologic
13 Participants
n=39 Participants
8 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
21 Participants
n=146 Participants
Cancer type
Gastrointestinal
10 Participants
n=39 Participants
2 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
12 Participants
n=146 Participants
Cancer type
Genitourinary
5 Participants
n=39 Participants
7 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
12 Participants
n=146 Participants
Cancer type
Head and neck
4 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
5 Participants
n=146 Participants
Cancer type
Skin
3 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
4 Participants
n=146 Participants
Cancer type
Lung
0 Participants
n=39 Participants
3 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
3 Participants
n=146 Participants
Cancer type
Other
2 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
3 Participants
n=146 Participants
Cancer type
Sarcoma
1 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
2 Participants
n=146 Participants
Cancer type
N/A
0 Participants
n=39 Participants
0 Participants
n=41 Participants
17 Participants
n=35 Participants
14 Participants
n=31 Participants
31 Participants
n=146 Participants
Cancer type
Missing
3 Participants
n=39 Participants
4 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
7 Participants
n=146 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm

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.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=39 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=30 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Anxiety--patients
-1.4 score on a scale
Standard Deviation 3.5
-1.5 score on a scale
Standard Deviation 2.7

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm

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.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=39 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=31 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Depression--patients
-1.2 score on a scale
Standard Deviation 3.1
0 score on a scale
Standard Deviation 2.5

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm

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.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=12 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Anxiety--caregivers
-0.4 score on a scale
Standard Deviation 3.2
0.3 score on a scale
Standard Deviation 2.4

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm

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.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=12 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Depression--caregivers
-1.2 score on a scale
Standard Deviation 2.0
-0.3 score on a scale
Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm

The National Comprehensive Cancer Network Distress Thermometer will be used to assess current distress level in patient-participants. 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".

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=40 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=31 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Distress--patients
-0.8 score on a scale
Standard Deviation 3.2
-0.5 score on a scale
Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm

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.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=40 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=32 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Fatigue--patients
-0.8 score on a scale
Standard Deviation 2.0
0 score on a scale
Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm

The 8-item Patient-Reported Outcomes Measurement Information System(PROMIS) pain interference 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. Scores range from 8 to 40 with higher scores indicating more interference due to pain.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=30 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=20 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Pain Interference--patients
-2.2 score on a scale
Standard Deviation 8.3
0.8 score on a scale
Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm

The National Comprehensive Cancer Network Distress Thermometer will be used to assess current distress level in caregiver-participants. 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".

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=13 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Distress--caregivers
-0.7 score on a scale
Standard Deviation 2.2
-0.2 score on a scale
Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm

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.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=13 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Fatigue--caregivers
-0.8 score on a scale
Standard Deviation 1.2
-0.1 score on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm

The 8-item Patient-Reported Outcomes Measurement Information System(PROMIS) pain interference 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. Scores range from 8 to 40 with higher scores indicating more interference due to pain.

Outcome measures

Outcome measures
Measure
Intervention Arm--PATIENTS
n=9 Participants
Patient-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. Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Wait List Control Arm--PATIENTS
n=8 Participants
Patient-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). Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
Change in Pain Interference--caregivers
2.2 score on a scale
Standard Deviation 4.6
-0.4 score on a scale
Standard Deviation 6.0

Adverse Events

Intervention Arm--PATIENTS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Wait List Control Arm--PATIENTS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Intervention Arm--CAREGIVERS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wait List Control Arm--CAREGIVERS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elaine Kurtovich

Kaiser Permanente Northern California

Phone: 510-891-3118

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place