An interventional study of Mindfulness meditation program (administered via mobile app) and Progressive muscle relaxation (via mobile app) in Distress, Cancer and Chemotherapy Effect, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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.
Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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)
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)
Mobile app-based/online mindfulness meditation program
Mobile app-based/online progressive muscle relaxation program
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 8 weeks
Change in Distress--patients
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".
Time frame: Baseline to 8 weeks
Change in Fatigue--patients
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.
Time frame: Baseline to 8 weeks
Change in Pain Interference--patients
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.
Time frame: Baseline to 8 weeks
Change in Distress--caregivers
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".
Time frame: Baseline to 8 weeks
Change in Fatigue--caregivers
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.
Time frame: Baseline to 8 weeks
Change in Pain Interference--caregivers
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.
Time frame: Baseline to 8 weeks
| Milestone | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|---|---|
| Started | 54 | 43 | 17 | 14 |
| Completed | 40 | 32 | 13 | 13 |
| Not completed | 14 | 11 | 4 | 1 |
| Withdrew: Death | 1 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 5 | 8 | 4 | 1 |
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.
| score on a scale | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS |
|---|---|---|
| Change in Anxiety--patients | -1.4 ± 3.5 | -1.5 ± 2.7 |
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.
| score on a scale | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS |
|---|---|---|
| Change in Depression--patients | -1.2 ± 3.1 | 0 ± 2.5 |
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.
| score on a scale | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|
| Change in Anxiety--caregivers | -0.4 ± 3.2 | 0.3 ± 2.4 |
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.
| score on a scale | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|
| Change in Depression--caregivers | -1.2 ± 2.0 | -0.3 ± 2.0 |
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".
| score on a scale | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS |
|---|---|---|
| Change in Distress--patients | -0.8 ± 3.2 | -0.5 ± 1.8 |
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.
| score on a scale | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS |
|---|---|---|
| Change in Fatigue--patients | -0.8 ± 2.0 | 0 ± 1.5 |
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.
| score on a scale | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS |
|---|---|---|
| Change in Pain Interference--patients | -2.2 ± 8.3 | 0.8 ± 8.5 |
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".
| score on a scale | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|
| Change in Distress--caregivers | -0.7 ± 2.2 | -0.2 ± 1.9 |
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.
| score on a scale | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|
| Change in Fatigue--caregivers | -0.8 ± 1.2 | -0.1 ± 1.6 |
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.
| score on a scale | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|
| Change in Pain Interference--caregivers | 2.2 ± 4.6 | -0.4 ± 6.0 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm--PATIENTS | 1/54 (1.9%) | 0/54 (0%) | 0/54 (0%) |
| Wait List Control Arm--PATIENTS | 2/43 (4.7%) | 0/43 (0%) | 0/43 (0%) |
| Intervention Arm--CAREGIVERS | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Wait List Control Arm--CAREGIVERS | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| Mean | 59.3 ± 14.1 | 56.7 ± 14.7 | 57.1 ± 17.4 | 58.2 ± 18.6 | 58.0 ± 15.1 |
| Sex: Female, Male(Participants) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| Female | 33 | 33 | 9 | 9 | 84 |
| Male | 21 | 10 | 8 | 5 | 44 |
| Race (NIH/OMB)(Participants) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 4 | 3 | 0 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 1 | 0 | 1 | 7 |
| White | 36 | 27 | 15 | 9 | 87 |
| More than one race | 8 | 9 | 2 | 2 | 21 |
| Unknown or Not Reported | 1 | 3 | 0 | 0 | 4 |
| Race/Ethnicity, Customized(Participants) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| Race — White | 36 | 27 | 15 | 9 | 87 |
| Race — African American | 5 | 1 | 0 | 1 | 7 |
| Race — Asian | 4 | 3 | 0 | 2 | 9 |
| Race — Other | 8 | 9 | 2 | 2 | 21 |
| Race — Unknown/not reported | 1 | 3 | 0 | 0 | 4 |
| Education(Participants) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| Some college or less | 18 | 19 | 6 | 5 | 48 |
| College graduate | 15 | 18 | 6 | 4 | 43 |
| Postgraduate degree | 20 | 6 | 5 | 5 | 36 |
| Missing | 1 | 0 | 0 | 0 | 1 |
| Income(Participants) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| Less than $75 000 | 11 | 21 | 2 | 3 | 37 |
| $75 000 to $99 999 | 7 | 5 | 3 | 3 | 18 |
| $100 000 to $149 999 | 18 | 8 | 5 | 1 | 32 |
| $150 000 or more | 12 | 5 | 5 | 3 | 25 |
| Missing | 6 | 4 | 2 | 4 | 16 |
| Cancer type(Participants) | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS | Total |
|---|---|---|---|---|---|
| Breast | 13 | 15 | 0 | 0 | 28 |
| Hematologic | 13 | 8 | 0 | 0 | 21 |
| Gastrointestinal | 10 | 2 | 0 | 0 | 12 |
| Genitourinary | 5 | 7 | 0 | 0 | 12 |
| Head and neck | 4 | 1 | 0 | 0 | 5 |
| Skin | 3 | 1 | 0 | 0 | 4 |
| Lung | 0 | 3 | 0 | 0 | 3 |
| Other | 2 | 1 | 0 | 0 | 3 |
| Sarcoma | 1 | 1 | 0 | 0 | 2 |
| N/A | 0 | 0 | 17 | 14 | 31 |
| Missing | 3 | 4 | 0 | 0 | 7 |
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