Clinical trial NCT03751995: POEM (Practice of Embracing Each Moment) Study (Delivery Science)
Official title: POEM (Practice of Embracing Each Moment) Study (Delivery Science)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Depression
Anxiety
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot pragmatic cluster randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of mHealth two mindfulness interventions as part of standard palliative care support within Kaiser Permanente Northern California.

Detailed description: A cancer diagnosis is associated with high levels of distress in both patients and their family caregivers. Although studies have demonstrated that mindfulness-based interventions are effective in reducing distress and anxiety of cancer patients, logistical limitations of currently available mindfulness-based stress reduction training options restrict their potential to benefit patients with advanced cancer and their caregivers. Previous pilot mindfulness studies targeting cancer patients and caregivers have demonstrated preliminary feasibility and acceptability of mHealth mindfulness interventions and preliminary efficacy in reducing depression, anxiety and improving quality of life. The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of two mHealth mindfulness interventions as part of standard palliative care support within KPNC. Using data collected through the mindfulness programs, patient/caregiver surveys, clinician surveys, and EHR data, the study aims are: 1) to assess acceptability and feasibility of incorporating an mHealth mindfulness intervention as part of palliative care and to obtain preliminary efficacy of the intervention on patient-reported outcomes, clinical outcomes, and health care utilization; and 2) to gather qualitative feedback regarding the intervention from the clinicians, patients and caregivers. Participating oncology clinics will be randomized into either intervention or usual care arms. Intervention participants may choose from a 6-week webinar-based mindfulness program or a 6-week self-paced mobile app-based mindfulness program. Controls will receive usual care. Rates of participation, completion and adherence among intervention participants and participant-reported outcomes on distress and quality of life among both arms at baseline, post-intervention and 12 weeks will be collected. The hypothesis is that participants in the intervention arm will experience reductions in depression/anxiety and improvement in immune function and quality of life. Clinician surveys and interviews with intervention participants will also be conducted at the end of the intervention to obtain feedback regarding the intervention.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Baseline to 6 weeks
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
timeFrame: Baseline to 6 weeks
measure: Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
timeFrame: Baseline to 12 weeks
measure: Change in Brief COPE coping strategy questionnaire (patients only)
timeFrame: Baseline to 6 weeks
measure: Change in Brief COPE coping strategy questionnaire (patients only)
timeFrame: Baseline to 12 weeks
measure: Change in Post-Traumatic Growth Inventory
timeFrame: Baseline to 6 weeks
measure: Change in Post-Traumatic Growth Inventory
timeFrame: Baseline to 12 weeks
measure: Change in Five Facet Mindfulness Questionnaire
timeFrame: Baseline to 6 weeks
measure: Change in Five Facet Mindfulness Questionnaire
timeFrame: Baseline to 12 weeks
measure: Change in Caregiver Quality of Life-Cancer scale (caregivers only)
timeFrame: Baseline to 6 weeks
measure: Change in Caregiver Quality of Life-Cancer scale (caregivers only)
timeFrame: Baseline to 12 weeks
measure: Change in PROMIS pain interference scale (caregivers only)
timeFrame: Baseline to 6 weeks
measure: Change in PROMIS pain interference scale (caregivers only)
timeFrame: Baseline to 12 weeks
measure: Change in PROMIS sleep disturbance scale (caregivers only)
timeFrame: Baseline to 6 weeks
measure: Change in PROMIS sleep disturbance scale (caregivers only)
timeFrame: Baseline to 12 weeks
measure: Change in Brief Fatigue Inventory (caregivers only)
timeFrame: Baseline to 6 weeks
measure: Change in Brief Fatigue Inventory (caregivers only)
timeFrame: Baseline to 12 weeks
measure: Change in Distress Thermometer
timeFrame: Baseline to 6 weeks
measure: Change in Distress Thermometer
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Ai Kubo, PhD
role: PRINCIPAL_INVESTIGATOR
References: