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CancerNCT05002842

Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)

A study testing LovingKindess Meditation in people with Cancer and Stress, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer, Stress
What is being tested?
LovingKindess Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
979 participants
Where
1 siteUnited States
Study dates
1 May 2018to 1 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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

Conditions
Cancer, Stress
Being tested
LovingKindess Meditation
Keywords
Cancer, Gratitude, Social Support, Online, Perceived Stress, CaringBridge, Social Connectedness, Social Assurance
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LovingKindess MeditationBehavioural

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

Study groups in NCT05002842
Study groupRoleWhat they receive
Immediate InterventionExperimentalThose in the immediate intervention arm will begin the LovingKindess Meditation practice upon enrollment.
Receives: Behavioral: LovingKindess Meditation
Delayed InterventionExperimentalThose 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.
Receives: Behavioral: LovingKindess Meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 weeks

Secondary outcomes (4)

  1. Change in Self-Compassion: The Self-Compassion Scale

    The Self-Compassion Scale (SCS) is a 12-item, shortened version of the original longer 26-item self-compassion scale (range 12-60). The 12-item SCS contains the same higher-order factor structure as the 26-item scale with a general Higher-Order Self-Compassion factor and six second-order factors of Self-Kindness, Self-Judgement, Common Humanity, Isolation, Mindfulness, and Over-Identification. All 12 items are assessed by asking how often a respondent felt a certain way on a 5-point Likert measure (1 =Almost never; 5 =Almost always). Higher SCS scores are associated with psychological well-being and suggest self-compassion might be an important protective factor, fostering emotional resilience.

    This will be assessed at baseline and week three, in addition to week six for the deferred arm.

    Measured: 3 weeks

  2. Change in Compassionate Love: The Compassionate Love for Humanity Scale

    The Compassionate Love Scale (CLS) is a 21-item measure of the stranger-humanity version of the original CLS designed to measure compassionate love for humanity (range 38-147). Higher CLS scores indicate greater compassionate love for humanity.

    This will be assessed at baseline and week three, in addition to week six for the deferred arm.

    Measured: 3 weeks

  3. Change in Social Support: The Social Connectedness Scale

    Social connectedness is assessed with 8 items on a 6-point Likert scale (1 = strongly agree through 6 = strongly disagree), with a total range of 8-48. Social connectedness is reverse coded such that high scores indicate higher social connection.

    This will be assessed at baseline and week three, in addition to week six for the deferred arm.

    Measured: 3 weeks

  4. Change in Social Support: The Social Assurance Scale

    Social assurance is assessed with 8 items on a 6-point Likert scale (1 = strongly agree through 6 = strongly disagree), with a total range of 8-48. Social Assurance is reverse coded such that high scores indicate higher social assurance. This will be assessed at baseline and week three, in addition to week six for the deferred arm.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 May 2018
  3. Primary completion1 Dec 2018
  4. Study completion1 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
979 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002842
Sponsor's protocol ID
1703S09842
Status last verified
May 2023
First submitted
4 Aug 2021
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35167360

Questions about this trial

What is this clinical trial studying?

A study testing LovingKindess Meditation in people with Cancer and Stress, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perceived Stress: The Perceived Stress Scale (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05002842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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