Support for Bereaved Cancer Caregivers

NCT06662409 | Recruiting DMC

• 1 other identifier: R03CA282943
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Bereavement; Cancer; Caregiver; Grief

Keywords

nature-based intervention; meditation; bereavement support; grief; directed attention; quality of life; anxiety; depression; cancer caregiver

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  From baseline to the end of intervention at 12 weeks

Study Arms (1)

Nature-based healing meditation (NBHM) intervention

EXPERIMENTAL

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

Other: Nature-based healing meditation (NBHM) intervention

Interventions

Nature-based healing meditation (NBHM) intervention 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)

Nature-based healing meditation (NBHM) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unwilling to perform return demonstration with 90% accuracy

Sponsors & Collaborators

• Michigan State University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Michigan State University College of Nursing

East Lansing, Michigan, 48824, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Rebecca H Lehto, PhD

CONTACT

(517) 353-4757; lehtor@msu.edu

Gwen Wyatt, PhD

CONTACT

(517)432-5511; gwyatt@msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)