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

NCT ID: NCT03751995

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-04-29

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.

Conditions

Advanced Cancer; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control

Participants from medical centers assigned to the control arm will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants from medical centers assigned to the intervention arm will receive access to their choice of a mindfulness app or a webinar-based mindfulness course for 6 weeks.

Group Type: EXPERIMENTAL

Mindfulness meditation

Intervention Type: BEHAVIORAL

Participants in the intervention group will have their choice of two commercially available mindfulness programs, HeadspaceTM and eMindful for 6 weeks.

The Headspace program provides progressive guided mindfulness meditation instruction via a website and mobile app to help users learn the skills of mindfulness for use in everyday life. Sessions last 3-20 minutes. Videos encourage the integration of mindfulness into daily life.

eMindful offers an online virtual classroom where participants can participate in synchronous, 1-hour mindfulness classes 1-2 times per week. The program is modeled after the mindfulness-based stress reduction (MBSR) program. eMindful also offers a cancer-specific meditation course that participants may choose to participate in.

Interventions

Mindfulness meditation

Participants in the intervention group will have their choice of two commercially available mindfulness programs, HeadspaceTM and eMindful for 6 weeks.

The Headspace program provides progressive guided mindfulness meditation instruction via a website and mobile app to help users learn the skills of mindfulness for use in everyday life. Sessions last 3-20 minutes. Videos encourage the integration of mindfulness into daily life.

eMindful offers an online virtual classroom where participants can participate in synchronous, 1-hour mindfulness classes 1-2 times per week. The program is modeled after the mindfulness-based stress reduction (MBSR) program. eMindful also offers a cancer-specific meditation course that participants may choose to participate in.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ai Kubo, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Northern California

Oakland, California, United States

Countries

United States

Other Identifiers

CN-18-3183

Identifier Type: -

Identifier Source: org_study_id