POEM (Practice of Embracing Each Moment) Study (Delivery Science)



Status:Recruiting
Conditions:Anxiety, Anxiety, Cancer, Cancer, Depression
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/24/2018
Start Date:October 31, 2018
End Date:December 2019
Contact:Elaine Kurtovich, MPH
Email:Elaine.M.Kurtovich@kp.org
Phone:510-891-3118

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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.

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.

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
We found this trial at
1
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Oakland, California 94612
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Oakland, CA
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