This resubmission is in response to PA-07-046, """"""""Research on mind body interactions and health."""""""" The National Cancer Institute is particularly concerned about cancer survivorship in which the caregiver is viewed as an integral component of the patient's recovery process. The number of adult caregivers exceeded 5.9 million in 2000, affecting over 22.4 million households in the US. Although caregivers may reduce medical care costs of the patient, the impact on the caregiver is substantial leading to lost work, financial burden, and increased medical and mental health problems. There is an extensive literature on the impact of caregiving on psychological well being, immune regulation, and neuroendocrine balance. Perturbations in these basic homeostatic processes have long term health consequences for the caregivers. Caregivers of patients receiving allogeneic blood and marrow transplants (BMT) are faced with a stressful experience marked by uncertainly and the likelihood of iatrogenic illness in the patient such as graft versus host disease associated with BMT. Approval for an allogeneic BMT requires the presence of a 24 hour caregiver for at least 100 days and quite often longer. Although a number of interventions have targeted the cancer patient, there have been few that have focused on the caregiver cancer patients and even fewer that have followed biomarkers in association with these interventions. Stress management and psychoeducation has been demonstrated as useful when dependent variables include behavioral markers. However many intervention studies have used convenience samples, failed to randomize treatments, did not include control groups for comparison purposes, or omitted biomarkers. The present study proposes a randomized control trial with intent to treat of BMT patient caregivers assigned to either treatment as usual or individualized stress management psychoeducation that includes a biofeedback device for training paced respiration which also tracks compliance. Dependent measures include caregiver and patient health, immune and endocrine markers, sleep characteristics via actimetry, and behavioral assessments of stress, depression, anxiety, and burden. This unique stress management psychoeducation intervention is expected to have positive effects on biomarkers of caregiver physical and psychological health including sleep, immune markers (natural cytotoxicity and Type 1 and 2 cytokine balance), and endocrine markers (diurnal variations in salivary cortisol and DHEA) compared to treatment as usual. This intervention focuses on needs of caregivers raised by the Surgeon General's Rx for caregivers at fundamental levels by 1) addressing issues around depression and anxiety, 2) identifying sources of support within the community for the caregivers, 3) focusing on the role of the caregiver's own health in their care of the patient, 4) sensitizing the caregivers to their stress and its effects on them, 5) teaching the caregiver about the illness their loved one is experiencing, and 6) providing stress management tools.
RELEVENCE. In a nation where three out of every four American families will have at least one member diagnosed with cancer, survivorship according to the National Cancer Institute (NCI) includes both the patient and those who support them. Caregivers are a distressed group which has become the focus of the NCI as well as the Office of the Surgeon General. Caregivers of blood and marrow transplant (BMT) patients are a particularly distressed group since their care is required 24/7 for the first 100 days following transplantation. The present study will test using a randomized control design, the impact of a stress management psychoeducation program versus treatment as usual on the physical and mental health of BMT caregivers since caregiver health is crucial to the long term prognosis in BMT patients as well.
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