An interventional study of Nature-based healing meditation (NBHM) intervention in Bereavement, Cancer and Caregiver, sponsored by Michigan State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Michigan State University · Not applicable, Interventional, and Supportive care
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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.
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.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 7,704 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
- Unwilling to perform return demonstration with 90% accuracy
6 nature-based healing meditation (NBHM) auditory modules intervention
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to the end of intervention at 12 weeks
Started Nov 2024 (actual). Primary completion is estimated for May 2027, 30 months after the start.
Of 1,983 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 30 months is close to that.
Counting every sponsor, half of 2,058 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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