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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different stress management techniques can reduce stress for caregivers of patients undergoing allogeneic HCT (a type of stem cell transplant). Participants will either learn mindfulness skills through a program called FOCUS, follow guidance from the American Cancer Society’s Caregiver Resource Guide in the Healthy Living sessions, or receive standard support options like support groups. The goal is to determine which approach best helps caregivers manage stress. This trial suits caregivers who are the primary support for patients at Moffitt Cancer Center during treatment. As an unphased trial, it offers caregivers the chance to explore innovative stress management techniques tailored to their needs.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness-based stress reduction programs, such as the FOCUS program, are generally safe and manageable. Studies have found that these programs reduce anxiety, depression, and stress without harmful side effects. Participants often feel more relaxed and better equipped to manage stress after attending these sessions.

For the Healthy Living sessions, which follow guidelines from the American Cancer Society's Caregiver Resource Guide, specific safety data is less available. However, these programs typically focus on improving general well-being, which is generally safe for most people. The sessions aim to enhance lifestyle habits and provide support, which are unlikely to cause serious issues.

Overall, both treatments are designed to support caregivers and are considered safe based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for caregiver stress because they offer fresh approaches to managing stress effectively. The FOCUS program introduces mindfulness techniques, encouraging caregivers to direct attention to their breath or body, which can help manage thoughts and emotions. This method stands out because it incorporates formal mindfulness meditations and daily exercises, which are not typically part of standard care. Meanwhile, the Healthy Living program builds on the American Cancer Society's Caregiver Resource Guide, combining in-person and virtual sessions to provide more comprehensive support. Both treatments aim to equip caregivers with practical skills for stress management, potentially offering more personalized and holistic care compared to traditional support groups and social worker meetings.

What evidence suggests that this trial's stress management interventions could be effective for caregiver stress?

Research has shown that mindfulness-based programs, such as the FOCUS program, which participants in this trial may receive, can reduce stress and improve mental health for caregivers. These programs lower stress and emotional distress and can even enhance sleep. One study found that mindfulness practices can help caregivers adapt their thinking, enabling them to handle stress more effectively.

The Healthy Living program, another treatment option in this trial, draws on resources from the American Cancer Society. Although specific data on its effectiveness in this context is unavailable, similar programs typically offer valuable support and stress management tools for caregivers. Both programs in this trial aim to help caregivers manage stress more effectively, which is crucial for their well-being. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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