540 Participants Needed

Stress Management for Caregiver Stress

KB
CV
SW
Overseen BySierra Washington
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment FOCUS, Healthy Living for managing caregiver stress?

The FOCUS Program, a similar intervention, showed better outcomes for caregivers and patients in managing stress and maintaining quality of life compared to usual care. Additionally, stress management interventions have been shown to reduce caregiver distress, which can improve the quality of life for both caregivers and patients.12345

Is the Stress Management for Caregiver Stress treatment safe for humans?

The research articles provided do not contain specific safety data for the Stress Management for Caregiver Stress treatment or its related programs like FOCUS or Healthy Living. They focus on the effects of caregiver stress and potential interventions but do not address the safety of these specific treatments.678910

How does this treatment for caregiver stress differ from other treatments?

This treatment is unique because it combines mindfulness meditation and self-administered acupressure into a social media-based mind-body intervention, making it more accessible and easier to adhere to compared to traditional methods that may be costly or difficult to practice.7891112

Research Team

CV

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for English-reading individuals who are primary caregivers to patients scheduled for allogeneic HCT at Moffitt Cancer Center. They must own a smartphone, be willing to use a study app, and plan to remain the main caregiver throughout treatment.

Inclusion Criteria

I plan to be the main caregiver during the patient's treatment.
You understand the study and agree to participate in it.
I am caring for someone getting a donor stem cell transplant at Moffitt.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stress management interventions through six 45-60 minute sessions, either in-person or via video conference.

8 weeks
3 visits (in-person), 3 visits (virtual)

Follow-up

Participants are monitored for stress management effectiveness and healthcare utilization post-treatment.

6 months

Treatment Details

Interventions

  • FOCUS
  • Healthy Living
Trial OverviewThe study is testing two stress management methods: Healthy Living guidelines and FOCUS program, aiming to see their effect on reducing stress in caregivers of allogeneic HCT cancer patients.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: FOCUSExperimental Treatment1 Intervention
Focusing On mindfulness for Caregivers Under Stress (FOCUS)will consist of six one-on-one, 45-60 minute sessions delivered either in-person (sessions 1-3) or via video conference (sessions 4-6). The first few sessions will primarily focus on how to direct attention to the breath or some object of attention (e.g., parts of the body). As the program progresses, participants are asked to apply these skills to thoughts and emotions. Throughout the treatment, caregivers are reminded to utilize existing coping skills, as well as how to integrate the new skills learned throughout this program for managing stress. Formal mindfulness meditations are conducted within each session, lasting from 7-20 minutes; participants will be asked to practice mindfulness exercises daily.
Group II: Healthy LivingActive Control1 Intervention
Healthy Living (HL) will consist of six, 45-60 minute sessions delivered one-on-one; sessions 1-3 in-person on HCT unit and sessions 4-6 via video conference. HL will be based on the American Cancer Society's (ACS) Caregiver Resource Guide.
Group III: Standard of Care - Enhanced CareActive Control1 Intervention
Participants in Enhanced Care will receive treatment consistent with what is offered to all caregivers of allogeneic HCT patients. This entails the option of attending weekly support groups and meeting with social workers as needed. At the baseline session, participants randomized to Enhanced Care will be provided with a modified version of the ACS Caregiver Resource Guide.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The caregiver stress management intervention, PsychoEducation, Paced Respiration, and Relaxation (PEPRR), significantly reduced caregiver distress over 3 months, indicating its efficacy in supporting caregivers of patients undergoing allogeneic hematopoietic stem cell transplant.
Despite the reduction in caregiver distress, the intervention did not lead to a significant improvement in patient quality of life as measured by the FACT-BMT scale, suggesting that the scale may not capture the psychological benefits of caregiver support.
A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress.Laudenslager, ML., Simoneau, TL., Mikulich-Gilbertson, SK., et al.[2020]
Both family counseling and support groups effectively helped caregivers of dementia patients manage stress and burden, showing significant improvements over time.
Despite the positive outcomes from both treatments, there was no significant difference in effectiveness between the two approaches, as wait-list subjects also showed similar improvements, indicating that the benefits may be due to the passage of time rather than the specific interventions.
Interventions with care givers of dementia patients: comparison of two approaches.Zarit, SH., Anthony, CR., Boutselis, M.[2022]
The study aims to evaluate a personalized just-in-time adaptive intervention using mobile sensor data and self-reported health-related quality of life (HRQOL) to support care partners of individuals with chronic health conditions, with data collection completed over a 3-month period.
Participants will be divided into two groups: one receiving personalized feedback through an app and the other receiving no feedback, allowing researchers to assess the feasibility and acceptability of this intervention in improving the well-being of care partners.
An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial.Carlozzi, NE., Choi, SW., Wu, Z., et al.[2022]

References

A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. [2020]
Interventions with care givers of dementia patients: comparison of two approaches. [2022]
An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial. [2022]
Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. [2022]
Family caregiver stress: clinical assessment and management. [2019]
Stress as a challenge in promoting mental health among dementia caregivers. [2023]
Nutrition education may reduce burden in family caregivers of older adults. [2019]
Integrating caregiver health into patient care. [2005]
Health-promoting self-care in family caregivers. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Informal caregiving and its impact on health: a reappraisal from population-based studies. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Caregiving, mortality, and mobility decline: the Health, Aging, and Body Composition (Health ABC) Study. [2022]
Effects of a Social Media-Based Mind-Body Intervention Embedded With Acupressure and Mindfulness for Stress Reduction Among Family Caregivers of Frail Older Adults: Pilot Randomized Controlled Trial. [2023]