Stress Management for Caregiver Stress
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Disqualifiers: Under 21, others
No Placebo Group
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?
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
Trial 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 (Behavioral Intervention)
- Healthy Living (Behavioral Intervention)
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
Research Locations NearbySelect from list below to view details:
Moffitt Cancer CenterTampa, FL
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Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Trials
576
Patients Recruited
145,000+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+
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]Psychological interventions reduce caregiver distress (CG-distress). Less distress in caregivers may contribute to improved patient quality of life (QoL), but empirical evidence is lacking. Will a caregiver stress management intervention improve patient QoL?
Interventions with care givers of dementia patients: comparison of two approaches. [2022]We compared the effect of two approaches, family counseling and support groups, for relieving the stress and burden experienced by care givers of dementia patients. Both treatments are designed to implement features of a stress-management model that have been identified in prior research with this population: providing information about the patient's disease and its effects on behavior, teaching behavioral problem solving for managing difficult behavior, and identifying potential support for care givers. Subjects were primary care givers of dementia patients living in the community; they included husbands, wives, daughters, and other relatives. Although subjects in the treatment groups made significant gains over time, they did not differ from wait-list subjects who showed similar improvements. One-year follow-up interviews indicated that gains made during the treatment period were maintained.
An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial. [2022]Care partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes.
Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. [2022]Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined (i) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a brief or extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care and (ii) whether patients' risk for distress and other factors moderated the effect of the brief or extensive program on outcomes.
Family caregiver stress: clinical assessment and management. [2019]This intervention study compares the effectiveness of two approaches on caregiving stress reduction. Caregivers' psychobiological symptom experience and coping were profiled over time by identifying the types of stress-related symptoms most frequently experienced. Following pretesting (and selected matching procedures) using family functioning, coping, stress and mental status instruments, random assignment of caregivers was made to one of four groups: educative/didactic, psychotherapeutic/support, placebo, or control. Patients were tested at the end of eight weekly 2-hour sessions and again at 1-, 3-, 6-, and 12-month intervals after treatment. Although both the educative and psychotherapeutic groups were effective interventions for the reduction of strain, the psychotherapeutic/support group was the most effective over time, both at posttest and at the 3-month intervals. Neither group intervention was more effective than the control groups in reducing other types of stress, including anxiety, somatization, or depression. The psychobiological symptoms experienced by caregivers peaked at crisis periods in the caregiving trajectory, or when multiple demands were made of the caregiver during any one point in time.
Stress as a challenge in promoting mental health among dementia caregivers. [2023]Caregiver stress is harmful to the health of both caregivers and people living with Alzheimer's disease or other dementias. The present study was conducted to assess stress and its predictors of people living with Alzheimer's disease or other dementias' caregivers.
Nutrition education may reduce burden in family caregivers of older adults. [2019]The chronic, demanding nature of family caregiving for frail older adults creates a high degree of stress for caregivers, called caregiver burden. Caregiver burden compromises caregivers' emotional and physical health and health-promoting behaviors. Deterioration in caregivers' health and nutritional status may put caregivers at risk for chronic disease, diminish the ability of caregivers to provide care, and impair the quality of life experienced by caregivers and care recipients. Nutrition education may help reduce caregiver stress and maintain caregivers' health and well-being. Mediating caregiver stress may allow family caregivers to meet their societal role, which has intensified because of health care cost containment.
Integrating caregiver health into patient care. [2005]As the population of older adults continues to grow, there will be a simultaneous increase in the number of informal spousal and family caregivers. Given the demands of caregiving, informal caregivers are at risk for significant mental and physical health problems. Since many patients are dependent upon the caregiver to assist them with health-care needs, identifying caregiver needs and making appropriate referrals during patient visits is vital to ensuring quality care for your primary patient. The three main objectives for this review article are to 1) Provide an overview of negative mental and physical health consequences of caregiver stress, 2) Discuss the benefits to both patient and caregiver of addressing caregiver stress, and 3) Suggest ways in which caregiver stress can be identified and resources provided in health clinics with minimal staff time. A bibliography of resources for health care staff, patients, and families is included at the conclusion of the article.
Health-promoting self-care in family caregivers. [2022]Caregiving for family members with cognitive impairment is stressful and time consuming. Because of the attention needed to manage the memory and behavior problems of the care receiver, family caregivers have little time to attend to their own health needs. Most research related to the health of family caregivers has been conducted within a stress-illness framework. Fewer researchers have studied caregiver health from a health-promotion paradigm. The purpose of this study was to compare health-promoting self-care behavior infamily caregivers with demographically matched noncaregivers and to investigate the mediational effect of health-promoting self-care behavior on the relationship between stress and well-being. Findings revealed that family caregivers scored significantly lower on all measures of health promotion, with the exception of Nutrition and Number of Medications, and significantly higher on Barriers to Health-Promoting Actions. Health-promoting self-care behavior acted as a mediator to reduce the effect of caregiver stress on general well-being.
Informal caregiving and its impact on health: a reappraisal from population-based studies. [2022]Considerable research and public discourse on family caregiving portrays it as a stressful and burdensome experience with serious negative health consequences. A landmark study by Schulz and Beach that reported higher mortality rates for strained spouse caregivers has been widely cited as evidence for the physical health risks of caregiving and is often a centerpiece of advocacy for improved caregiver services. However, 5 subsequent population-based studies have found reduced mortality and extended longevity for caregivers as a whole compared with noncaregiving controls. Most caregivers also report benefits from caregiving, and many report little or no caregiving-related strain. Policy reports, media portrayals, and many research reports commonly present an overly dire picture of the health risks associated with caregiving and largely ignore alternative positive findings. As the pool of traditional family caregivers declines in the coming years, a more balanced and updated portrayal of the health effects of caregiving is needed to encourage more persons to take on caregiving roles, and to better target evidence-based services to the subgroup of caregivers who are highly strained or otherwise at risk. Recommendations are discussed for research that will better integrate and clarify both the negative and potential positive health effects of informal caregiving.
Caregiving, mortality, and mobility decline: the Health, Aging, and Body Composition (Health ABC) Study. [2022]Although caregivers report more stress than noncaregivers, few studies have found greater health decline in older caregivers. We hypothesized that caregivers may be more physically active than noncaregivers, which may protect them from health decline.
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]Family caregivers of frail older adults experience high levels of stress. Mind-body interventions (MBIs) focused on caregiver stress are often limited in teaching approaches, difficult to practice, and costly. A social media-based MBI embedded with mindfulness meditation (MM) and self-administered acupressure (SA) may be effective for family caregivers, offer greater usability, and lead to greater adherence.