Catherine E. Mosher, Ph.D. - US grants

[unreadable] DESCRIPTION (provided by applicant): Nearly two decades of research with primarily healthy samples have documented that writing about one's emotions associated with negative events over several brief sessions can enhance physical and psychological well-being. Promising studies with predominantly early-stage cancer patients suggest that expressive writing produces health benefits such as reduced pain and medical visits for cancer-related morbidities. Research to date has not examined the potential benefits of expressive writing for women with metastatic breast cancer who confront a growing dependence on others, cognitive and physical decline, and the ultimate prospect of death. Data suggest that most advanced cancer patients desire to share their cancer-related thoughts and feelings with others and view emotional and existential concerns as very important. Yet, some patients feel constrained in discussing their cancer-related experiences, and very few formal interventions have been developed to help cancer patients cope with end-of-life concerns. In this study, 74 women with Stage IV breast cancer will be randomly assigned to one of two conditions: 1) emotional disclosure writing intervention, or 2) control writing. Women in the emotional disclosure writing condition will write about their deepest thoughts and feelings regarding their breast cancer experience, whereas women in the control writing condition will write about their daily activities in a detailed manner. Women in both conditions will be asked to complete four, 20-minute writing sessions that are administered via telephone. Assessments will be conducted before the intervention and at 8 weeks post- intervention. Primary outcomes include indices of distress (i.e., depressive symptoms and demoralization), and secondary outcomes include a sense of meaning in life and peace, pain severity, sleep disturbance, fatigue, and functional impairment. We hypothesize that women assigned to the emotional disclosure writing condition will experience better psychological and physical health at follow-up relative to controls. We also hypothesize that the writing intervention will be most beneficial for women who feel constrained in discussing their cancer experience with others. This study will provide new information regarding the feasibility and utility of a telephone- administered expressive writing intervention for advanced cancer patients. Consistent with the mission of the National Cancer Institute, this research aims to promote public health by reducing adverse outcomes of cancer and its treatment and enhancing patients' well-being. Results of this project have the potential to inform future studies of emotional disclosure interventions for cancer patients and clinical practice. [unreadable] [unreadable] [unreadable]

Research has shown that a significant proportion of advanced cancer patients'family caregivers (30% to 50%) experience clinically significant distress. Lung cancer is the most common cause of cancer deaths, and patients with this disease experience more symptom distress relative to patients with other cancer types, which may increase care-giving demands. Currently, there is limited knowledge of the reasons that cancer patients'family caregivers underutilize psychosocial support services, and there is a paucity of research-based interventions that are tailored to the needs of this population. In this study, a sample of primary family caregivers (e.g., spouses, adult children;N = 80) with clinically significant distress will be recruited to complete individual phone assessments approximately 4 to 6 weeks after the patient's lung cancer diagnosis and three months later. A subsample (n = 30) that has not accessed psychosocial services over the study period will also complete a qualitative interview within 2 weeks of the 3- month follow-up. The study aims are to examine: (1) psychosocial and practical needs of primary family caregivers of lung cancer patients;(2) psychosocial and practical barriers to psychosocial support service use in this population;and (3) family caregivers'preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions. Finally, the extent to which theory-driven demographic and psychosocial variables at baseline predict subsequent psychosocial support service use among family caregivers will be assessed. Results will directly inform the design and delivery of new psychosocial interventions that are tailored to the needs of lung cancer patients'family caregivers. In addition, this study will provide new and valuable information for identifying distressed family caregivers of lung cancer patients who are less likely to use psychosocial support services and developing strategies to increase appropriate use of these services.

DESCRIPTION (provided by applicant): Lung cancer is frequently advanced at diagnosis, and over 80% of lung cancer patients experience multiple symptoms, such as depression, anxiety, pain, fatigue, and breathlessness, which negatively impact their quality of life. Family caregivers of lung cancer patients also experience high rates of anxiety and depressive symptoms and poor quality-of-life outcomes. This application proposes a program of research and career training focused on improving patient-caregiver dyads' physical and psychological adjustment to lung cancer. The proposed research will further develop and test a novel, dyad-focused telephone symptom management (TSM) intervention with the potential to treat highly prevalent and disabling symptoms in advanced lung cancer patients and their caregivers. The intervention is a blend of evidence-based cognitive-behavioral and emotion- focused strategies that include instruction in relaxation, adaptive thinking and communication skills, and activity planning and pacing. While prior studies have primarily tested cognitive-behavioral interventions to improve patients' and couples' adjustment to early-stage cancer, TSM addresses advanced cancer patients' and caregivers' concerns and combines cognitive-behavioral and emotion-focused approaches. The proposed research includes two phases. In Phase 1, qualitative interviews will be conducted with advanced lung cancer patients and caregivers (N = 24 dyads) to ensure that the intervention is sensitive to the needs and preferences of the target population. The intervention will then be revised based on the qualitative findings. In Phase 2, advanced lung cancer patients who meet established clinical cutoffs for at least one of five symptoms (i.e., depressive symptoms, anxiety, pain, fatigue, or breathlessness) and their family caregivers (e.g., spouse, other relative) who meet clinical cutoffs for depressive symptoms or anxiety (N = 100 dyads) will be randomized to (1) five weekly phone sessions of TSM intervention tailored to patients' and caregivers' symptoms, or (2) five weekly phone sessions of an attention control condition that provides an overview of resources for psychosocial support and health information. Assessments will be administered at baseline and 2 and 6 weeks post-intervention. Brief symptom assessments will also be administered to patients and caregivers during each intervention or control session. Patient outcomes will include symptom control (i.e., depressive symptoms, anxiety, pain, fatigue, breathlessness, and overall symptom burden), functional status, quality of life, and quality of relationship with the caregiver. Caregiver outcomes will include depressive symptoms, anxiety, strain, quality of life, and quality of relationship with the patient. Patient and caregiver self- efficacy for symptom management also will be assessed as potential mediators of the effects of TSM on outcomes. The proposed research has the potential to provide valuable, new information that can aid in selecting strategies for helping advanced lung cancer patients and their family caregivers better manage symptoms. The career development plan includes training in the natural history and clinical aspects of lung cancer and theories and research methods for developing and evaluating technology-based interventions for cancer patient-caregiver dyads. Through a combination of mentored research, coursework, seminars, and directed learning experiences, the applicant will develop the necessary skills for building an independently funded program of research focused on improving patient-caregiver dyads' physical and psychological adjustment to cancer.

Project Summary/Abstract Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of advanced gastrointestinal (GI) cancer patients. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing responsibilities. Evidence-based interventions addressing cancer patient fatigue interference and caregiver burden are lacking. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. We recently conducted a pilot study in metastatic breast cancer that tested a novel ACT intervention combining acceptance and mindfulness exercises (e.g., meditations, performing activities with greater awareness) with identification of personal values and engagement in activities consistent with these values. This telephone-based intervention showed strong evidence of feasibility, acceptability, and promise for reducing fatigue interference with activities, mood, and cognition. The proposed pilot study builds upon this patient-focused work to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 40 patient-caregiver dyads will be randomly assigned in equal numbers to either the ACT intervention or an education/support control condition. Dyads in both conditions will attend six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT on improving patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities, psychological flexibility, and quality of life. We will also explore the effects of ACT on patient and caregiver physical and mental health service use. Study findings will inform an R01 application to conduct a large-scale trial of intervention efficacy. Results will also provide a foundation for a program of research focused on the novel application of ACT to symptom interference with functioning and caregiver burden in advanced cancer.

Project Summary/Abstract Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer patients and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. We recently conducted a pilot study in metastatic breast cancer that tested a novel telephone- based ACT intervention combining mindfulness exercises (e.g., meditations, performing activities with greater awareness) with identification of personal values and engagement in activities consistent with these values. The intervention showed strong evidence of feasibility, acceptability, and promise with respect to reducing fatigue interference with activities, mood, and cognition. The proposed Phase II trial seeks to more definitively examine the efficacy of our telephone-based ACT intervention for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women will be randomly assigned in equal numbers to either the ACT intervention or an education/support control condition. Women in both conditions will attend six weekly 50-minute telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post- intervention. This trial will also examine whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in action aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to metastatic breast cancer patients. This trial will also lay the groundwork for further application and testing of ACT with a wide range of cancer populations and functional outcomes.