Stress Management for Caregiver Stress

Overseen By Sierra Washington

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Under 21, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

540 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{7 8 9 11 12}

Research Team

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.

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 Overview The 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

Group I: FOCUS Experimental Treatment 1 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 Living Active Control 1 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 Care Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study involving 484 patient-caregiver dyads found that both brief (three-session) and extensive (six-session) interventions improved coping, self-efficacy, and quality of life (QOL) for patients and caregivers, particularly in social and emotional aspects.

Most positive effects were observed at the three-month mark, indicating that while the interventions were beneficial, the improvements may not be sustained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Northouse, LL., Mood, DW., Schafenacker, A., et al.[2022]

The study found that both educative and psychotherapeutic interventions effectively reduced caregiving strain, but the psychotherapeutic/support approach was the most effective over time, particularly at the 3-month follow-up.

Despite the effectiveness in reducing strain, neither intervention significantly impacted other stress-related symptoms like anxiety, somatization, or depression, indicating a need for targeted strategies for these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family caregiver stress: clinical assessment and management. Baldwin, BA., Kleeman, KM., Stevens, GL., et al.[2019]

The study assessed caregiver stress among 99 individuals caring for patients with Alzheimer's disease, revealing a mean stress score of 25.4, with higher stress levels observed in female and informal caregivers.

Key predictors of caregiver stress included the caregiver's relationship to the patient, type of caregiving, and prior experience with Alzheimer's care, highlighting the need for targeted support to improve mental health among caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress as a challenge in promoting mental health among dementia caregivers. Zahed, S., Emami, M., Eslami, AA., et al.[2023]

Caregiver burden from caring for frail older adults significantly impacts the emotional and physical health of caregivers, potentially leading to chronic diseases and reduced quality of life for both caregivers and care recipients.

Nutrition education is suggested as a beneficial intervention to alleviate caregiver stress and promote the health and well-being of caregivers, enabling them to fulfill their caregiving roles more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education may reduce burden in family caregivers of older adults. Silver, HJ., Wellman, NS.[2019]

Informal caregivers of older adults face significant mental and physical health challenges due to the stress of caregiving, which can impact the quality of care they provide to their patients.

Addressing caregiver stress not only benefits the caregivers' well-being but also enhances the overall care for patients, highlighting the importance of identifying caregiver needs during health visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating caregiver health into patient care. Sorocco, KH., Belzer, A., Teasdale, T.[2005]

Family caregivers for individuals with cognitive impairment engage in significantly less health-promoting self-care behavior compared to noncaregivers, indicating a need for better support for their health needs.

Health-promoting self-care behaviors can help mediate the negative effects of caregiver stress on overall well-being, suggesting that encouraging these behaviors may improve caregivers' health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-promoting self-care in family caregivers. Acton, GJ.[2022]

Contrary to the common belief that caregiving is overwhelmingly stressful and harmful to health, recent studies indicate that caregivers may actually experience lower mortality rates and greater longevity compared to non-caregivers.

Many caregivers report positive experiences and benefits from their roles, suggesting that the narrative around caregiving needs to be more balanced to reflect both the challenges and the rewards, especially as the number of traditional family caregivers declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informal caregiving and its impact on health: a reappraisal from population-based studies. Roth, DL., Fredman, L., Haley, WE.[2022]

In a study of 3,075 healthy older adults, caregivers showed higher rates of mortality (20.6%) and mobility limitations (50.9%) compared to noncaregivers, with significant differences observed based on race and sex.

Physical activity was found to mediate the health outcomes of caregivers, suggesting that while high-intensity caregiving is associated with poorer health, being physically active may help mitigate these negative effects, particularly in older white caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiving, mortality, and mobility decline: the Health, Aging, and Body Composition (Health ABC) Study. Fredman, L., Cauley, JA., Satterfield, S., et al.[2022]

A pilot study involving 64 family caregivers of frail older adults showed that an 8-week social media-based mind-body intervention, which included mindfulness meditation and self-administered acupressure, significantly reduced caregiver stress and improved sleep quality and mindfulness awareness compared to a control group.

The intervention demonstrated high feasibility with an 87.5% attendance rate and low attrition (1.6%), indicating that it is a practical and engaging option for caregivers, although it did not significantly reduce caregiver burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sui, Y., Kor, PPK., Li, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Interventions with care givers of dementia patients: comparison of two approaches. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Family caregiver stress: clinical assessment and management. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Stress as a challenge in promoting mental health among dementia caregivers. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Nutrition education may reduce burden in family caregivers of older adults. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Integrating caregiver health into patient care. [2005]

9. United States pubmed.ncbi.nlm.nih.gov

Health-promoting self-care in family caregivers. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Informal caregiving and its impact on health: a reappraisal from population-based studies. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Caregiving, mortality, and mobility decline: the Health, Aging, and Body Composition (Health ABC) Study. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

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]