Browsing by Author "Keefe, Francis"
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Item Open Access Improving health engagement and lifestyle management for breast cancer survivors with diabetes.(Contemporary clinical trials, 2020-05) Shelby, Rebecca A; Dorfman, Caroline S; Arthur, Sarah S; Bosworth, Hayden B; Corsino, Leonor; Sutton, Linda; Owen, Lynda; Erkanli, Alaattin; Keefe, Francis; Corbett, Cheyenne; Kimmick, GretchenBreast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.Item Open Access Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).(Contemporary clinical trials, 2019-01) Shelby, Rebecca A; Dorfman, Caroline S; Bosworth, Hayden B; Keefe, Francis; Sutton, Linda; Owen, Lynda; Corsino, Leonor; Erkanli, Alaattin; Reed, Shelby D; Arthur, Sarah S; Somers, Tamara; Barrett, Nadine; Huettel, Scott; Gonzalez, Juan Marcos; Kimmick, GretchenAdjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov, NCT02707471, registered 3/3/2016.Item Open Access The influence of a cognitive behavioural approach on changing patient expectations for conservative care in shoulder pain treatment: a protocol for a pragmatic randomized controlled trial.(BMC musculoskeletal disorders, 2021-08-24) Myers, Heather; Keefe, Francis; George, Steven Z; Kennedy, June; Lake, Ashley Davis; Martinez, Corina; Cook, ChadBackground
Despite similar outcomes for surgery and conservative care, the number of surgeries to treat rotator cuff related shoulder pain has increased. Interventions designed to enhance treatment expectations for conservative care have been shown to improve patient expectations, but no studies have yet explored whether such interventions influence patient decisions to pursue surgery. The purpose of this randomized clinical trial is to examine the effect of an intervention designed to improve expectations of conservative care on the decision to have surgery.Methods
We will test the effectiveness of the Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention which is intended to change expectations regarding conservative care. The PEERC intervention will be evaluated in a randomized, pragmatic "add-on" trial, to better understand the effect the intervention has on outcomes. Ninety-four (94) participants with rotator cuff related shoulder pain referred for physical therapy will be randomized to receive either impairment-based care or impairment-based care plus PEERC. Both groups will receive impairment-based conservative treatment created by compiling the evidence associated with established, effective interventions. Participants assigned to the impairment-based care plus PEERC condition will also receive the PEERC intervention. This intervention, informed by principles of cognitive behavioral therapy, involves three components: (1) strategies to enhance engagement, (2) education and (3) cognitive restructuring and behavioral activation. Outcomes will be assessed at multiple points between enrolment and six months after discharge. The primary outcome is patient reported decision to have surgery and the secondary outcomes are pain, function, expectations and satisfaction with conservative care.Discussion
Rotator cuff related shoulder pain is highly prevalent, and because conservative and surgical treatments have similar outcomes, an intervention that changes expectations about conservative care could alter patient reports of their decision to have surgery and ultimately could lead to lower healthcare costs and decreased risk of surgical complications.Trial registration
This study is registered as NCT03353272 at ClincialTrials.gov.