Feasibility of Symptom Monitoring During the First Year of Endocrine Therapy for Early Breast Cancer Using Patient-Reported Outcomes Collected via Smartphone App.

PURPOSE: Treatment-associated symptoms drive early discontinuation of adjuvant endocrine therapy (ET) for breast cancer. We hypothesized that symptom monitoring with electronic patient-reported outcomes (ePROs) during adjuvant ET will enhance symptom detection, symptom management, and persistence. METHODS: Eligible patients were initiating ET for stage 0-III breast cancer. Participants completed ePRO surveys via smartphone at baseline and 1, 3, 6, and 12 months. Measures included Patient-Reported Outcomes Measurement Information System Anxiety, Depression, Fatigue, and Vaginal Discomfort; plus Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items assessing joint pain, hot flashes, vaginal dryness, concentration problems, and memory problems. Scores surpassing prespecified thresholds triggered alerts, and recommended symptom management pathways were provided to clinicians. The primary objective was to evaluate feasibility, assessed by survey completion rates, with targets of >65% for the baseline survey and ≥1 follow-up survey during the first 6 months. Secondary objectives included 12-month ET discontinuation rate (target: ≤15%), describing symptoms and evaluating pathway implementation. RESULTS: Among 250 participants, 73.2% completed the baseline survey and 69.6% completed ≥1 follow-up survey during the first 6 months. Thirty-one percent of participants had ≥1 symptom alert at baseline and 74% had ≥1 symptom alert during follow-up. The proportions of participants for whom pathway-concordant symptom management was documented at each time point ranged from 12.8% to 36.6%. Twenty-eight participants (11.2%) discontinued ET by 12 months. CONCLUSION: Symptom monitoring with ePROs during adjuvant ET is feasible. Despite infrequent documentation of pathway-concordant symptom management after symptom alerts, ePROs were associated with favorable short-term ET persistence.

A PRO-cision medicine intervention to personalize cancer care using patient-reported outcomes: intervention development and feasibility-testing.

PURPOSE: PRO-cision medicine refers to personalizing care using patient-reported outcomes (PROs). We developed and feasibility-tested a PRO-cision Medicine remote PRO monitoring intervention designed to identify symptoms and reduce the frequency of routine in-person visits. METHODS: We conducted focus groups and one-on-one interviews with metastatic breast (n = 15) and prostate (n = 15) cancer patients and clinicians (n = 10) to elicit their perspectives on a PRO-cision Medicine intervention's design, value, and concerns. We then feasibility-tested the intervention in 24 patients with metastatic breast cancer over 6-months. We obtained feedback via end-of-study surveys (patients) and interviews (clinicians). RESULTS: Focus group and interview participants reported that remote PRO symptom reporting could alert clinicians to issues and avoid unneeded/unwanted visits. However, some patients did not perceive avoiding visits as beneficial. Clinicians were concerned about workflow. In the feasibility-test, 24/236 screened patients (10%) enrolled. Many patients were already being seen less frequently than monthly (n = 97) or clinicians did not feel comfortable seeing them less frequently than monthly (n = 31). Over the 6-month study, there were 75 total alerts from 392 PRO symptom assessments (average 0.19 alert/assessment). Patients had an average of 4 in-person visits (vs. expected 6.5 without the intervention). Patients (n = 19/24) reported high support on the end-of-study survey, with more than 80% agreeing with positive statements about the intervention. Clinician end-of-study interviews (n = 11/14) suggested that PRO symptom monitoring be added to clinic visits, rather than replacing them, and noted the increasing role of telemedicine. CONCLUSIONS: Future research should explore combining remote PRO symptom monitoring with telemedicine and in-person visits.

Restriction of range effects in post-metabolic and bariatric surgery outcomes research: considerations for clinical decision making.

BACKGROUND: Preoperative psychopathology does not consistently predict postoperative outcomes in patients who undergo metabolic and bariatric surgery (MBS). Individuals with elevated pre-MBS psychopathology may be less likely to undergo surgery, which may create a floor effect given the limited range of scores on measures of psychopathology included in postoperative analyses, thereby decreasing the power to detect clinically significant differences between groups. OBJECTIVES: Our objective was to compare rates of clinically significant pre-MBS psychopathology across domains of functioning in patients who did and did not undergo MBS: surgical completers (SCs, n = 286) and nonsurgical completers (NSCs, n = 125). SETTING: Academic medical center, United States. METHODS: Participants (n = 411) were a racially diverse sample of MBS candidates who completed a preoperative psychosocial evaluation including measures of disordered eating, alcohol and tobacco use, pain catastrophizing, anxiety, and depressive symptomatology. RESULTS: Compared with SCs, NSCs had larger scale score variance on measures of psychopathology and were more likely to be Black; to report clinically significant scores on measures of binge eating, depression, anxiety, and pain catastrophizing; and to use tobacco. CONCLUSION: Results support the presence of a restriction-of-range effect but do not demonstrate a floor effect. These data suggest that current outcome data for MBS patients may not generalize to those who report clinically significant psychopathology at the pre-MBS psychosocial evaluation and may warrant caution when using the current literature to inform clinical decision making for this group. Findings also suggest a need for interventions that will better engage Black patients.

Sleep disturbance and insomnia in individuals seeking bariatric surgery.

BACKGROUND: Sleep disturbance is well established in individuals with obesity, and the relationship between poor sleep and obesity is supported by population, longitudinal, experimental, and intervention studies. However, the prevalence and characteristics of poor sleep in individuals seeking bariatric surgery have thus far been poorly examined. OBJECTIVES: We sought to characterize self-reported sleep parameters in individuals seeking bariatric surgery and to compare these data with controls. SETTING: Two Academic Medical Centers, United States, and an online survey of healthy controls. METHOD: Individuals seeking bariatric surgery (n = 427) completed presurgical psychological evaluations at 2 comprehensive bariatric surgery programs. Data on medical co-morbidities and from self-report questionnaires on sleep quality, insomnia, anxiety, and depression were abstracted from charts. Data from controls (n = 180) were collected using an online survey tool and compared with bariatric cases. RESULTS: Across study sites, 40.4% of bariatric cases took at least 30 minutes to fall asleep, 46.7% had insufficient total sleep time (<6.5 hr), 65.1% reported general poor sleep quality, and 30.8% reported clinically significant insomnia symptoms. Approximately 20% of the variance in poor sleep quality and insomnia was explained by body mass index, obstructive sleep apnea, anxiety, and depression. Cases and controls were similar, although bariatric cases reported significantly poorer sleep efficiency. CONCLUSIONS: Our results suggest that similar to a control population, the majority of patients seeking bariatric surgery are experiencing sleep difficulties. Presurgical assessment and treatment of sleep problems may be beneficial to patients and may help improve weight loss treatment outcomes. Optimally, assessment would include 1 of the 2 self-report questionnaires used herein, and treatment would involve Cognitive Behavioral Therapy for Insomnia. Future research assessing sleep patterns with objective measurement tools and evaluating the impact of sleep on postsurgical outcomes is warranted.