BereavementNCT06662409
Support for Bereaved Cancer Caregivers
A study testing Nature-based healing meditation (NBHM) intervention in people with Bereavement and Cancer, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bereavement, Cancer, Caregiver
- What is being tested?
- Nature-based healing meditation (NBHM) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Aug 2027
- Phase
- Interventional
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
- 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)
Who cannot join
- Unwilling to perform return demonstration with 90% accuracy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University College of Nursing
East Lansing, Michigan, 48824
Rebecca Lehto, PhD, 5174325511, lehtor@msu.edu
About this study
Official title: Support for Bereaved Friend and Family Caregivers of Cancer Patients
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.
Read the 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.
- Conditions
- Bereavement, Cancer, Caregiver, Grief
- Being tested
- Nature-based healing meditation (NBHM) intervention
- Keywords
- nature-based intervention, meditation, bereavement support, grief, directed attention, quality of life, anxiety, depression, cancer caregiver
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based healing meditation (NBHM) interventionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Nature-based healing meditation (NBHM) intervention | Experimental | 6 nature-based healing meditation (NBHM) auditory modules intervention Receives: Other: Nature-based healing meditation (NBHM) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
The 4-item Feasibility of Intervention Measure was developed for evaluating the success of feasibility, demonstrate encouraging psychometric properties. The items that are scored on a scale of 0 to 4 where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16 with higher scores indicating higher feasibility and acceptability.
Measured: From baseline to the end of intervention at 12 weeks
Acceptability of Intervention Measure
The 4-item Acceptability of Intervention Measure was developed for evaluating the success of acceptability, demonstrate encouraging psychometric properties. The items that are scored on a scale of 0 to 4 where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16 with higher scores indicating higher feasibility and acceptability.
Measured: From baseline to the end of intervention at 12 weeks
Attention Function Index
Directed attention will be assessed with the Attention Function Index, a 16-item self-rating scale that measures perceived effectiveness in daily tasks that require cognitive function. Items are scored on an 11-point Likert scale ranging from 0, indicating "not at all," to 10, indicating "extremely well or a great deal." Higher scores indicate better cognitive functioning.
Measured: From baseline to the end of intervention at 12 weeks
Prolonged Grief 13-Revised
Grief (Bereavement) will be measured with the Prolonged Grief 13-Revised prolonged grief scale, Ongoing testing demonstrates that the measure is consistently reliable and a valid instrument for classifying less adaptive grief responses. Thirteen items to assess symptoms of prolonged grief disorder. Ten items are scored on a Likert-style scale from 1, "not at all," to 5 "overwhelmingly" to indicate how often that item describes how they are feeling. Three of the items assess whether the respondent had lost a significant other, how long ago the death occurred, and impairment associated with symptoms. Scores of 30 or greater on the symptom items indicate prolonged grief disorder (PGD), and were associated with poorer emotional and mental health as well as work and social adjustment difficulties.
Measured: From baseline to the end of intervention at 12 weeks
PROMIS-29: Quality of life
The PROMIS profile instruments are a collection of profile short forms, where each form contains items from 1 of 7 primary PROMIS domains (emotional, social, and physical function, pain interference, fatigue, sleep disturbance, health satisfaction). PROMIS tools were developed to create psychometrically robust fixed-length short forms that can be used across trials and clinical conditions.
The PROMIS-29 assesses each domain with 4 questions each. Items are on a 5-point Likert scale that ranges from 0 to 4.
Measured: From baseline to the end of intervention at 12 weeks
Acceptability and Feasibility Tracking
participant numbers referred vs numbers eligible; numbers eligible vs. number consented; numbers consented vs. number completed; number of weeks using the intervention.
Measured: From baseline to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Nov 2024
- Primary completion31 May 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rebecca Lehto, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662409
- Sponsor's protocol ID
- R03CA282943
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No