Cancer, Chemotherapy Effect, Distress
Conditions
Keywords
anxiety, quality of life, mindfulness, meditation, depression
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.
Interventions
BEHAVIORALMindfulness meditation program (administered via mobile app)
Mobile app-based/online mindfulness meditation program
BEHAVIORALProgressive muscle relaxation (via mobile app)
Mobile app-based/online progressive muscle relaxation program
Sponsors
American Cancer Society, Inc.
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety--patients | Baseline to 8 weeks | 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. |
| Change in Depression--patients | Baseline to 8 weeks | 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. |
| Change in Anxiety--caregivers | Baseline to 8 weeks | 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. |
| Change in Depression--caregivers | Baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue--caregivers | Baseline to 8 weeks | 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. |
| Change in Distress--patients | Baseline to 8 weeks | 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. |
| Change in Pain Interference--caregivers | Baseline to 8 weeks | 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. |
| Change in Fatigue--patients | Baseline to 8 weeks | 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. |
| Change in Pain Interference--patients | Baseline to 8 weeks | 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. |
| Change in Distress--caregivers | Baseline to 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 54 |
| 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 | 43 |
| 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 | 17 |
| 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 | 14 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 8 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Intervention Arm--PATIENTS | Wait List Control Arm--PATIENTS | Intervention Arm--CAREGIVERS | Wait List Control Arm--CAREGIVERS |
|---|---|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 15.1 | 59.3 years STANDARD_DEVIATION 14.1 | 56.7 years STANDARD_DEVIATION 14.7 | 57.1 years STANDARD_DEVIATION 17.4 | 58.2 years STANDARD_DEVIATION 18.6 |
| Cancer type Breast | 28 Participants | 13 Participants | 15 Participants | 0 Participants | 0 Participants |
| Cancer type Gastrointestinal | 12 Participants | 10 Participants | 2 Participants | 0 Participants | 0 Participants |
| Cancer type Genitourinary | 12 Participants | 5 Participants | 7 Participants | 0 Participants | 0 Participants |
| Cancer type Head and neck | 5 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants |
| Cancer type Hematologic | 21 Participants | 13 Participants | 8 Participants | 0 Participants | 0 Participants |
| Cancer type Lung | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants |
| Cancer type Missing | 7 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants |
| Cancer type N/A | 31 Participants | 0 Participants | 0 Participants | 17 Participants | 14 Participants |
| Cancer type Other | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Cancer type Sarcoma | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Cancer type Skin | 4 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Education College graduate | 43 Participants | 15 Participants | 18 Participants | 6 Participants | 4 Participants |
| Education Missing | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education Postgraduate degree | 36 Participants | 20 Participants | 6 Participants | 5 Participants | 5 Participants |
| Education Some college or less | 48 Participants | 18 Participants | 19 Participants | 6 Participants | 5 Participants |
| Income $100 000 to $149 999 | 32 Participants | 18 Participants | 8 Participants | 5 Participants | 1 Participants |
| Income $150 000 or more | 25 Participants | 12 Participants | 5 Participants | 5 Participants | 3 Participants |
| Income $75 000 to $99 999 | 18 Participants | 7 Participants | 5 Participants | 3 Participants | 3 Participants |
| Income Less than $75 000 | 37 Participants | 11 Participants | 21 Participants | 2 Participants | 3 Participants |
| Income Missing | 16 Participants | 6 Participants | 4 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race African American | 7 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 9 Participants | 4 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 21 Participants | 8 Participants | 9 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Unknown/not reported | 4 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 87 Participants | 36 Participants | 27 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 4 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 21 Participants | 8 Participants | 9 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 87 Participants | 36 Participants | 27 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Female | 84 Participants | 33 Participants | 33 Participants | 9 Participants | 9 Participants |
| Sex: Female, Male Male | 44 Participants | 21 Participants | 10 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 54 | 2 / 43 | 0 / 17 | 0 / 14 |
| other Total, other adverse events | 0 / 54 | 0 / 43 | 0 / 17 | 0 / 14 |
| serious Total, serious adverse events | 0 / 54 | 0 / 43 | 0 / 17 | 0 / 14 |
Outcome results
Primary
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
Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Anxiety--caregivers | -0.4 score on a scale | Standard Deviation 3.2 |
| Wait List Control Arm--PATIENTS | Change in Anxiety--caregivers | 0.3 score on a scale | Standard Deviation 2.4 |
p-value: 0.79ANOVA
Primary
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
Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Anxiety--patients | -1.4 score on a scale | Standard Deviation 3.5 |
| Wait List Control Arm--PATIENTS | Change in Anxiety--patients | -1.5 score on a scale | Standard Deviation 2.7 |
p-value: 1ANOVA
Primary
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
Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Depression--caregivers | -1.2 score on a scale | Standard Deviation 2 |
| Wait List Control Arm--PATIENTS | Change in Depression--caregivers | -0.3 score on a scale | Standard Deviation 2 |
p-value: 0.29ANOVA
Primary
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
Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Depression--patients | -1.2 score on a scale | Standard Deviation 3.1 |
| Wait List Control Arm--PATIENTS | Change in Depression--patients | 0 score on a scale | Standard Deviation 2.5 |
p-value: 0.11ANOVA
Secondary
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
Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Distress--caregivers | -0.7 score on a scale | Standard Deviation 2.2 |
| Wait List Control Arm--PATIENTS | Change in Distress--caregivers | -0.2 score on a scale | Standard Deviation 1.9 |
p-value: 0.47ANOVA
Secondary
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
Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Distress--patients | -0.8 score on a scale | Standard Deviation 3.2 |
| Wait List Control Arm--PATIENTS | Change in Distress--patients | -0.5 score on a scale | Standard Deviation 1.8 |
p-value: 0.67ANOVA
Secondary
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
Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Fatigue--caregivers | -0.8 score on a scale | Standard Deviation 1.2 |
| Wait List Control Arm--PATIENTS | Change in Fatigue--caregivers | -0.1 score on a scale | Standard Deviation 1.6 |
p-value: 0.23ANOVA
Secondary
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
Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Fatigue--patients | -0.8 score on a scale | Standard Deviation 2 |
| Wait List Control Arm--PATIENTS | Change in Fatigue--patients | 0 score on a scale | Standard Deviation 1.5 |
p-value: 0.24ANOVA
Secondary
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
Population: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Pain Interference--caregivers | 2.2 score on a scale | Standard Deviation 4.6 |
| Wait List Control Arm--PATIENTS | Change in Pain Interference--caregivers | -0.4 score on a scale | Standard Deviation 6 |
p-value: 0.39ANOVA
Secondary
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
Population: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--PATIENTS | Change in Pain Interference--patients | -2.2 score on a scale | Standard Deviation 8.3 |
| Wait List Control Arm--PATIENTS | Change in Pain Interference--patients | 0.8 score on a scale | Standard Deviation 8.5 |
p-value: 0.25ANOVA