Support for Bereaved Cancer Caregivers

NCT ID: NCT06662409

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-08-31

Brief Summary

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Friend and family caregivers of recently deceased cancer patients experience acute bereavement following the death. Post death bereavement is an intense period of mourning that includes an unfolding of the grief process and is characterized by strong emotions and demands on cognitive resources to those who have put aside their own needs to support the dying patient with cancer. This research will test the feasibility and acceptability of a nature-based healing meditation (NBHM) intervention to support cancer caregivers' during the bereavement process.

Detailed Description

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Bereaved friend and family caregivers have taken on the burden of end-of-life care for patients with cancer who die in hospice care at home. Bereavement can be emotionally devastating, especially to those who have put aside their own needs to support the dying individual. Supporting bereaved CGs' emotional health and general well-being is a critical need. The proposed pilot study will evaluate the acceptability and feasibility of a 6-week low-tech nature meditation intervention aimed at supporting bereaved caregivers' who are in the first 6 months since the patients' death. The intervention, based on the mutually supportive role that meditation practices and nature have been shown to promote wellbeing, will be developed capitalizing on the strengths of the research team's early intervention work involving patients with advanced cancer and their caregivers. For this single group longitudinal study, Aim 1 will focus on the development of 6 nature-based healing meditation (NBHM) auditory modules available via the study website to facilitate bereavement (grief) recovery and assessed on parameters of directed attention, grief, and QOL (including parameters of depression/anxiety).

The 2nd aim will then evaluate acceptability and feasibility of the 6-week program of both content and delivery methods (numbers eligible vs. number consented; numbers consented vs. numbers completed; number of weeks using the intervention) for the intervention modules. We will then conduct semi-structured interviews with a small diverse representative sample of caregivers to evaluate benefits, satisfaction, and challenges in more depth. Fifty-five home-based cancer caregivers who recently experienced the death of their patient will be recruited from Hospice of Michigan. Testing will occur at baseline (Time 1; study week 0), at the intervention end (Time 2; week 6), and (Time 3; study week 12). This research targets a supportive caregiver intervention that will be flexibly delivered on-line for use at the caregiver's convenience. Once feasibility and acceptability for this new intervention to support bereaved caregivers are addressed, a larger scale randomized control trial will be sought.

Conditions

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Bereavement Cancer Caregiver Grief

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nature-based healing meditation (NBHM) intervention

6 nature-based healing meditation (NBHM) auditory modules intervention

Group Type EXPERIMENTAL

Nature-based healing meditation (NBHM) intervention

Intervention Type OTHER

6 nature-based healing meditation (NBHM) auditory modules available via the study website to facilitate bereavement (grief) recovery and assessed on parameters of directed attention, grief, and QOL (including parameters of depression/anxiety)

Interventions

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Nature-based healing meditation (NBHM) intervention

6 nature-based healing meditation (NBHM) auditory modules available via the study website to facilitate bereavement (grief) recovery and assessed on parameters of directed attention, grief, and QOL (including parameters of depression/anxiety)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older; Able and willing to provide reflexology
* Able to speak and understand English
* Have access to a telephone
* Able to hear normal conversation
* Cognitively oriented to time, place, and person (determined via recruiter)

Exclusion Criteria

* Unwilling to perform return demonstration with 90% accuracy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Lehto

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Michigan State University College of Nursing

East Lansing, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca H Lehto, PhD

Role: CONTACT

(517) 353-4757

Gwen Wyatt, PhD

Role: CONTACT

(517)432-5511

Facility Contacts

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Rebecca Lehto, PhD

Role: primary

5174325511

Other Identifiers

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R03CA282943

Identifier Type: NIH

Identifier Source: org_study_id

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