NCT05002842

Brief Summary

CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users

Trial Health

87
On Track

Trial Health Score

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

Enrollment
979

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

August 4, 2021

Last Update Submit

May 8, 2023

Conditions

Keywords

CancerGratitudeSocial SupportOnlinePerceived StressCaringBridgeSocial ConnectednessSocial Assurance

Outcome Measures

Primary Outcomes (1)

  • Change in Perceived Stress: The Perceived Stress Scale

    The Perceived Stress Scale is a 10-item scale for measuring one's perception of stress. All 10 items are assessed by asking how often a respondent felt a certain way on a 5-point Likert measure (0 = Never; 4 = Very Often), with a minimum score of 0 and a maximum score of 40. Higher total scores indicate greater perceived stress. This will be assessed at baseline and week three, in addition to week six for the deferred arm.

    3 weeks

Secondary Outcomes (4)

  • Change in Self-Compassion: The Self-Compassion Scale

    3 weeks

  • Change in Compassionate Love: The Compassionate Love for Humanity Scale

    3 weeks

  • Change in Social Support: The Social Connectedness Scale

    3 weeks

  • Change in Social Support: The Social Assurance Scale

    3 weeks

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Those in the immediate intervention arm will begin the LovingKindess Meditation practice upon enrollment.

Behavioral: LovingKindess Meditation

Delayed Intervention

EXPERIMENTAL

Those in the deferred intervention arm will commence the LovingKindness Meditation practice intervention approximately 3 weeks (post 3 -week survey) after enrollment and participate three weeks thereafter.

Behavioral: LovingKindess Meditation

Interventions

Participants will have access to a recording of a script to guide them through meditation

Delayed InterventionImmediate Intervention

Eligibility Criteria

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

You may qualify if:

  • English literacy
  • CaringBridge user with an active email address
  • Visitor/Caregiver/Patient on a Cancer Journey (for Phase 2 only)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Telke S, Leininger B, Hanson L, Kreitzer MJ. A Randomized Trial of 21 Days of Loving Kindness Meditation for Stress Reduction and Emotional Well-being Within an Online Health Community for Patients, Family, and Friends Experiencing a Cancer Health Journey. J Integr Complement Med. 2022 Feb;28(2):158-167. doi: 10.1089/jicm.2020.0512. Epub 2022 Jan 11.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Mary Jo Kreitzer, PhD, RN, FAAN

    University of Minnesota Earl E. Bakken Center for Spirituality & Healing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations