A prospective, randomized trial of patient-reported outcome measures to drive management decisions in hematology and oncology.

Background: Clinicians have limited time during patient encounters which can result in patients' concerns not being addressed. This study's objective was to test whether an electronic patient-reported outcome quality of life tool (PROQOL) in which patients identify their primary concern during clinic visits improves cancer patient quality of life (QOL). Patients and methods: This single center non-blinded prospective clinical trial randomized patients (2:1) to PROQOL versus usual care (UC). Two patient cohorts were enrolled: those with hematologic malignancies (multiple myeloma [MM] or light chain amyloidosis [AL]) and solid tumors (head and neck [H/N] or gynecologic [GYN] malignancies). Primary endpoint was patient-reported QOL at 12 months measured by a single-item Linear Analog Self-Assessment. Value to patients and impact on clinician workflow was measured using a "was it worth it" survey. The study was powered to detect a 0.5 standard deviation difference between groups. Results: Overall 383 patients were enrolled, 171 with MM, 62 AL, 113 GYN, and 37 H/N between July 2016 and April 2018, with 12-month follow-up. There were 171 (44.6%) male patients and median age was 62 years (range 31-87). The most often selected concern was physical health (30.9%), and second was cancer diagnosis and treatment (29.1%). Mean QOL was 7.12 for PROQOL and 6.98 for UC (0-10 scale) at 12 months, with no between-group difference overall (p = 0.56) or within hematologic or solid tumor cohorts, respectively. Among patients, 74% thought the PROQOL tool was worthwhile, 86% would choose PROQOL again, and 81% would recommend it to others. Among clinicians, 95% responded that PROQOL was worthwhile and did not think that PROQOL negatively impacted their workflow. Conclusions: Although we did not demonstrate a QOL difference between PROQOL and UC groups; the PROQOL tool held considerable value in identifying patients' main concerns over time and was worthwhile for patients and clinicians.

A Case Management System for Integrating Patient-reported Outcome Assessment in Clinical Practice: The Beacon Tool.

INTRODUCTION: What if you could only ask one question of the patient during a clinic visit? Further, suppose the patient's biggest concern can pragmatically be incorporated into routine clinical care and clinical pathways that can address the patient's single biggest concern can be identified. If the principal concern can be dealt with efficiently at each visit through key stakeholder case management, positive outcomes should result. Therefore, motivated by the need for patient-centered health care visits, the Beacon electronic patient-reported outcomes (PRO) quality of life (QOL) tool was developed. METHODS: Central to the tool is that at each health care visit, the patient's biggest concern is electronically communicated to the health care team. Therefore, the tool can help catalyze important discussions between the health care team and the patient, perhaps on topics that would not have been discussed otherwise at a routine visit. In recognition of the community of resources needed to provide comprehensive care, the tool generates clinical pathways or actions that can be pursued to address the patient's biggest concern. The concern is efficiently triaged such that members of the health care community with appropriate expertise and resources are identified to address and manage that single biggest concern signaled by the patient. A report, which can be uploaded into the patient's medical chart, is created and provides a list of resources for a case manager to assist the patient and contains graphical presentations of the patient's QOL and a history of prior concerns. The report also labels potentially significant changes in QOL. DISCUSSION: The tool, which has been applied successfully in several health conditions, acts as a beacon to health care providers so that a patient's self-reported concern can be consistently and effectively integrated into their care. KEY POINTS: It is impractical to try to deal with every patient concern in every visit. The key to the Beacon tool is that at each visit the patient's biggest concern is identified, clinical pathways indicated, and resources efficiently matched to address the patient's biggest concern.

Family-Based Mindful Eating Intervention in Adolescents with Obesity: A Pilot Randomized Clinical Trial.

Mindfulness has gained attention in the treatment of obesity. However, there is a paucity of data on family-based training in mindful eating in children. The objective of this pilot randomized clinical trial was to evaluate the feasibility and acceptability of a family-based mindful eating intervention (MEI) in adolescents with obesity, and to compare the efficacy of the MEI versus standard dietary counseling (SDC) for decreasing weight and improving cardiometabolic risk markers. Twenty-two adolescents (age 14.5⁻17.9 years) and parent pairs were randomized to the MEI or SDC. The MEI was administered in four 90-min sessions over 10 weeks and SDC was provided at baseline, 12 weeks, and 24 weeks. Despite the requirement of more frequent visits with the MEI, adolescents and parents attended 100% of the sessions and there were no dropouts in that group. High density lipoprotein (HDL) cholesterol increased in the SDC group, but not in the MEI group. Adolescents receiving the MEI demonstrated an increase in awareness at 24 weeks (p = 0.01) and a decrease in distraction during eating at 12 weeks (p = 0.04), when compared with the SDC group. The family-based MEI showed feasibility and acceptability in adolescents with obesity. Future studies with more intense therapy and larger sample sizes are warranted to examine the role of mindful eating in treating pediatric obesity.

Randomized pilot trial of yoga versus strengthening exercises in breast cancer survivors with cancer-related fatigue.

PURPOSE: Fatigue is one of the most common and bothersome refractory symptoms experienced by cancer survivors. Mindful exercise interventions such as yoga improve cancer-related fatigue; however, studies of yoga have included heterogeneous survivorship populations, and the effect of yoga on fatigued survivors remains unclear. METHODS: We randomly assigned 34 early-stage breast cancer survivors with cancer-related fatigue (≥4 on a Likert scale from 1-10) within 1 year from diagnosis to a 12-week intervention of home-based yoga versus strengthening exercises, both presented on a DVD. The primary endpoints were feasibility and changes in fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Secondary endpoint was quality of life, assessed by the Functional Assessment of Cancer Therapies-Breast (FACT-B). RESULTS: We invited 401 women to participate in the study; 78 responded, and we enrolled 34. Both groups had significant within-group improvement in multiple domains of the fatigue and quality of life scores from baseline to post-intervention, and these benefits were maintained at 3 months post-intervention. However, there was no significant difference between groups in fatigue or quality of life at any assessment time. Similarly, there was no difference between groups in adherence to the exercise intervention. CONCLUSIONS: Both DVD-based yoga and strengthening exercises designed for cancer survivors may be good options to address fatigue in breast cancer survivors. Both have reasonable uptake, are convenient and reproducible, and may be helpful in decreasing fatigue and improving quality of life in the first year post-diagnosis in breast cancer patients with cancer-related fatigue.

Acupuncture in the postoperative setting for breast cancer patients: a feasibility study.

Acupuncture is used to treat a variety of symptoms and conditions associated with cancer and cancer treatments. The present study was performed to evaluate the feasibility of providing acupuncture in the hospital setting for breast cancer patients and to evaluate the short-term effect of acupuncture on stress, anxiety, and pain. This was an open label study conducted at Mayo Clinic Hospital, Methodist and Saint Marys Campus, Rochester, Minnesota. A total of 20 adult breast cancer patients undergoing mastectomy and/or breast reconstruction were recruited and offered daily acupuncture intervention beginning postoperative day 1 and continuing for the duration of the hospital stay. Outcome measures included the Symptom Visual Analog Scale (VAS) and Satisfaction Question and Was-it-Worth-it (WIWI) Questionnaire. It was found that acupuncture is a feasible option for postoperative breast cancer patients. In addition, it can significantly decrease the levels of anxiety (p = 0.0065), tension/muscular discomfort (p < 0.001) and pain (p = 0.023). The association between acupuncture and relaxation was found to be statistically borderline (p = 0.053). This feasibility study showed that acupuncture can be integrated into a busy postsurgical clinical practice. These results also suggest that acupuncture may be an important intervention in the postoperative setting for breast cancer patients.

Application of therapeutic harp sounds for quality of life among hospitalized patients.

CONTEXT: Hospitalized patients experience symptoms including pain and anxiety that may negatively affect their well-being and overall quality of life (QOL), even when medical interventions are deemed successful. OBJECTIVES: The objective of the study was to assess the efficacy of prescriptive live therapeutic harp sounds on patient symptoms and QOL. METHODS: The study was a two-period, two-treatment arm crossover, randomized clinical trial. Individuals were randomized to harp music and standard care for the first 24 hours of the hospital stay, followed by 24 hours of only standard care, or vice versa. The harp intervention was 30-40 minutes of prescriptive live therapeutic harp sounds in the form of solo harp pieces and improvisations. Patients recorded well-being and symptom scores on linear analogue scales. Entry criteria included at least 18 years and a score of 3 or below on a 1-5 linear analogue scale indicating compromised overall QOL. RESULTS: Ninety-two eligible patients participated in the clinical trial. All the QOL variables had significantly higher percentages of patients with improvements during the harp treatment than during standard care. Five symptoms--fatigue, anxiety, sadness, relaxation, and pain--were significantly improved following therapeutic harp treatment. Approximately 30% to 50% of patients showed a significant increase in the QOL measures after harp treatment. CONCLUSION: There is evidence of strong positive effects on the QOL of hospitalized patients who received therapeutic harp sound treatment along with standard care.