NCT03751995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

8 days

First QC Date

August 23, 2018

Last Update Submit

January 13, 2021

Conditions

Advanced CancerDepressionAnxiety

Outcome Measures

Primary Outcomes (2)

  • Change in Hospital Anxiety and Depression Scale

    The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.

    Baseline to 6 weeks

  • Change in Hospital Anxiety and Depression Scale

    The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.

    Baseline to 12 weeks

Secondary Outcomes (18)

  • Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)

    Baseline to 6 weeks

  • Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)

    Baseline to 12 weeks

  • Change in Brief COPE coping strategy questionnaire (patients only)

    Baseline to 6 weeks

  • Change in Brief COPE coping strategy questionnaire (patients only)

    Baseline to 12 weeks

  • Change in Post-Traumatic Growth Inventory

    Baseline to 6 weeks

  • +13 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness meditation

Interventions

Mindfulness meditationBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe hearing impairment
  • Severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94611, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ai Kubo, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pilot pragmatic cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

November 23, 2018

Study Start

October 31, 2018

Primary Completion

November 8, 2018

Study Completion

April 29, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)