Clinical trial NCT06662409: Support for Bereaved Cancer Caregivers
Official title: Support for Bereaved Friend and Family Caregivers of Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Bereavement
Cancer
Caregiver
Grief
Keywords: nature-based intervention
meditation
bereavement support
grief
directed attention
quality of life
anxiety
depression
cancer caregiver
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: From baseline to the end of intervention at 12 weeks
measure: Acceptability of Intervention Measure
timeFrame: From baseline to the end of intervention at 12 weeks
measure: Attention Function Index
timeFrame: From baseline to the end of intervention at 12 weeks
measure: Prolonged Grief 13-Revised
timeFrame: From baseline to the end of intervention at 12 weeks
measure: PROMIS-29: Quality of life
timeFrame: From baseline to the end of intervention at 12 weeks
measure: Acceptability and Feasibility Tracking
timeFrame: From baseline to the end of intervention at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University College of Nursing
state: Michigan
Study officials:
References: