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Recruiting NCT06662409

Support for Bereaved Cancer Caregivers

No phase Interventional Bereavement Cancer Caregiver Grief

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nature-based healing meditation (NBHM) intervention.
Who it may be relevant to
Registry conditions: Bereavement, Cancer, Caregiver, Grief. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Support for Bereaved Friend and Family Caregivers of Cancer Patients

Overview

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

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.

Interventions

  • Other 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)

Primary outcome measures

  • Feasibility of Intervention Measure [Time frame: From baseline to the end of intervention at 12 weeks]
  • Acceptability of Intervention Measure [Time frame: From baseline to the end of intervention at 12 weeks]
  • Attention Function Index [Time frame: From baseline to the end of intervention at 12 weeks]
  • Prolonged Grief 13-Revised [Time frame: From baseline to the end of intervention at 12 weeks]
  • PROMIS-29: Quality of life [Time frame: From baseline to the end of intervention at 12 weeks]
  • Acceptability and Feasibility Tracking [Time frame: From baseline to the end of intervention at 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Michigan State University College of Nursing — East Lansing

Identifiers

NCT: NCT06662409 · R03CA282943

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗