Follow-up assessment of sleep-related symptoms in patients after treatment for cancer: responses to continuous positive airway pressure treatment for co-morbid obstructive sleep apnoea.

PURPOSE: To assess changes in sleep-related symptoms in patients with breast cancer, endometrial cancer and melanoma previously examined for sleep-related symptoms and the presence of PSG (polysomnography)-determined OSA, ≥ 3 years post-treatment; and to evaluate how CPAP treatment affects sleep-related symptoms in patients previously diagnosed with OSA. METHODS: Patients initially recruited from breast cancer, endometrial cancer, and melanoma follow-up clinics at Westmead Hospital (Sydney, Australia) participated in this questionnaire-based study. Demographic and change in cancer status data were collected at follow-up. Patients completed the Pittsburgh Sleep Quality Index [poor sleep quality, PSQITOTAL ≥ 5au], Insomnia Severity Index, Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire; with ΔPSQITOTAL ≥ 3au indicating a clinically meaningful change in sleep quality over follow-up. PSG-determined OSA was confirmed using the apnoea-hypopnoea index. CPAP compliance was determined via self-report (CPAP compliant, CPAP; not compliant, non-CPAP). Logistic regression models determined if changes in cancer status, AHI, cancer subgroup or CPAP treatment was predictive of ΔPSQITOTAL ≥ 3 au and p < 0.05 indicated statistical significance. RESULTS: The 60 patients recruited had breast cancer (n = 22), endometrial cancer (n = 15), and melanoma (n = 23). Cancer subgroups were similarly aged, and all had median follow-up PSQITOTAL scores ≥ 5au; breast cancer patients scoring the highest (p < 0.05). The CPAP group had significantly reduced PSQITOTAL scores (p = 0.02) at follow-up, unlike the non-CPAP group. Cancer subgroups had similar median ISITOTAL, ESSTOTAL and FOSQ-10TOTAL scores at follow-up, regardless of CPAP treatment. There were no significant predictors of ΔPSQITOTAL ≥ 3 au at follow-up. CONCLUSION: Sleep-related symptoms persist in patients with cancer ≥ 3 years after treatment, although these symptoms improve with CPAP. Future studies should evaluate how CPAP affects survival outcomes in cancer patients with comorbid OSA.

A National Health and Wellness SMS Text Message Program for Breast Cancer Survivors During COVID-19 (EMPOWER-SMS COVID-19): Mixed Methods Evaluation Using the RE-AIM Framework.

BACKGROUND: COVID-19 lockdowns caused widespread closures of supportive care services for breast cancer survivors in Australia. In a randomized controlled trial, our team's lifestyle-focused, evidence-based SMS text message support program (EMPOWER-SMS COVID-19) was found to be acceptable and useful for breast cancer survivors, and it was ready for rapid widespread delivery. OBJECTIVE: This study aims to evaluate the reach (uptake) of an adapted 3-month lifestyle-focused SMS text message program (EMPOWER-SMS COVID-19) and barriers and enablers to implementation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. METHODS: A mixed methods pre-post study was conducted to evaluate the EMPOWER-SMS COVID-19 program. The study evaluated the following aspects: (1) reach/representativeness, which refers to the proportion of participant enrollment (ie, number enrolled/number that visited the study website) and demographics (eg, age, sex, ethnicity, time since completing treatment, Index of Relative Socio-economic Advantage and Disadvantage [IRSAD; quintile 1, which refers to most disadvantaged areas, to quintile 5, which refers to least disadvantaged areas, and remoteness); (2) effectiveness, in which participant engagement and acceptability were evaluated using SMS text message reply data and a feedback survey (5-point Likert scale and free-text responses); (3) adoption, which corresponds to the proportion of organizations or health professionals who agreed to promote the program; (4) implementation fidelity and maintenance, which evaluated SMS text message delivery data, opt-outs, costs, and adaptations. Quantitative data were summarized using means and SDs or frequencies and percentages, while qualitative data were analyzed thematically. RESULTS: With regard to the reach/representativeness of the program, 841/1340 (62.8%) participants enrolled and provided electronic consent. Participants had a mean age of 58.8 (SD 9.8; range 30-87) years. According to the data collected, most participants identified as female (837/840, 99.6%) and White (736/840, 87.6%) and nearly half (418/841, 49.7%) finished treatment ≤18 months ago. Most resided in major cities (574/838, 68.5%) and 30% (251/838) in IRSAD quintile 1 or 2. In terms of effectiveness, 852 replies were received from 511 unique participants (median 1; range 1-26). The most common replies were participants stating how they heard about the program (467/852, 54.8%) or "thank you" (131/852, 15.4%). None of the replies contained urgent safety concerns. Among participants who provided feedback (449/841, 53.4%), most "(strongly) agreed" the SMS text messages were easy to understand (445/448, 99.3%), useful (373/440, 84.8%), helped participants feel supported (388/448, 86.6%), and motivated participants to be physically active (312/445, 70.1%) and eat healthier (313/457, 68.5%). Free-text responses revealed 5 factors influencing engagement: (1) feeling supported and less alone, (2) motivation and reassurance for health self-management, (3) the variety of information, (4) weblinks to information and resources, and (5) the option to save the SMS text messages. Concerning adoption, 50% (18/36) of organizations/health professionals agreed to promote the program. With regard to implementation/maintenance, SMS text messages were delivered as planned (97.43% [41,257/42,344] of SMS text messages were successfully delivered) with minimal opt-outs (62/838, 7.4%) and low cost (Aus $15.40/participant; Aus $1=US $0.67). No adaptations were made during the intervention period. Postintervention adaptations included adding weblinks and participant-selected customizations. CONCLUSIONS: EMPOWER-SMS COVID-19 was implemented quickly, had a broad reach, and had high engagement and acceptability among socioeconomically diverse participants. The program had high fidelity, low cost, and required minimal staff oversight, which may facilitate future implementation. However, further research is needed to evaluate barriers and enablers to adoption and implementation for health professionals and strategies for long-term maintenance.

Evaluation of Vectra® XT 3D Surface Imaging Technology in Measuring Breast Symmetry and Breast Volume.

BACKGROUND: Breast symmetry is an essential component of breast cosmesis. The Harvard Cosmesis scale is the most widely adopted method of breast symmetry assessment. However, this scale lacks reproducibility and reliability, limiting its application in clinical practice. The VECTRA® XT 3D (VECTRA®) is a novel breast surface imaging system that, when combined with breast contour measuring software (Mirror®), aims to produce a more accurate and reproducible measurement of breast contour to aid operative planning in breast surgery. OBJECTIVES: This study aims to compare the reliability and reproducibility of subjective (Harvard Cosmesis scale) with objective (VECTRA®) symmetry assessment on the same cohort of patients. METHODS: Patients at a tertiary institution had 2D and 3D photographs of their breasts. Seven assessors scored the 2D photographs using the Harvard Cosmesis scale. Two independent assessors used Mirror® software to objectively calculate breast symmetry by analysing 3D images of the breasts. RESULTS: Intra-observer agreement ranged from none to moderate (kappa - 0.005-0.7) amongst the assessors using the Harvard Cosmesis scale. Inter-observer agreement was weak (kappa 0.078-0.454) amongst Harvard scores compared to VECTRA® measurements. Kappa values ranged 0.537-0.674 for intra-observer agreement (p < 0.001) with Root Mean Square (RMS) scores. RMS had a moderate correlation with the Harvard Cosmesis scale (rs = 0.613). Furthermore, absolute volume difference between breasts had poor correlation with RMS (R2 = 0.133). CONCLUSION: VECTRA® and Mirror® software have potential in clinical practice as objectifying breast symmetry, but in the current form, it is not an ideal test. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention.

BACKGROUND: To evaluate risk factors (treatment-related, comorbidities, and lifestyle) for breast cancer-related lymphedema (BCRL) within the context of a Prospective Surveillance and Early Intervention (PSEI) model of care for subclinical BCRL. METHODS: The parent randomized clinical trial assigned patients newly diagnosed with breast cancer to PSEI with either bioimpedance spectroscopy (BIS) or tape measurement (TM). Surgical, systemic and radiation treatments, comorbidities, and lifestyle factors were recorded. Detection of subclinical BCRL (change from baseline of either BIS L-Dex ≥6.5 or tape volume ≥ 5% and < 10%) triggered an intervention with compression therapy. Volume change from baseline ≥10% indicated progression to chronic lymphedema and need for complex decongestive physiotherapy. In this secondary analysis, multinomial logistic regressions including main and interaction effects of the study group and risk factors were used to test for factor associations with outcomes (no lymphedema, subclinical lymphedema, progression to chronic lymphedema after intervention, progression to chronic lymphedema without intervention). Post hoc tests of significant interaction effects were conducted using Bonferroni-corrected alphas of .008; otherwise, an alpha of .05 was used for statistical significance. RESULTS: The sample (n = 918; TM = 457; BIS = 461) was female with a median age of 58.4 years. Factors associated with BCRL risk included axillary lymph node dissection (ALND) (p < .001), taxane-based chemotherapy (p < .001), regional nodal irradiation (RNI) (p ≤ .001), body mass index >30 (p = .002), and rurality (p = .037). Mastectomy, age, hypertension, diabetes, seroma, smoking, and air travel were not associated with BCRL risk. CONCLUSIONS: Within the context of 3 years of PSEI for subclinical lymphedema, variables of ALND, taxane-based chemotherapy, RNI, body mass index >30, and rurality increased risk.

Impact of the EndoPredict genomic assay on treatment decisions for oestrogen receptor-positive early breast cancer patients: benefits of physician selective testing.

PURPOSE: Genomic tests improve accuracy of risk prediction for early breast cancers but these are expensive. This study evaluated the clinical utility of EndoPredict®, in terms of impact on adjuvant therapy recommendations and identification of parameters to guide selective application. METHODS: Patients with ER-positive, HER2-negative, and early-stage invasive breast cancer were tested with EndoPredict®. Two cohorts were recruited: one consecutively and another at clinical team discretion. Systemic treatment recommendations were recorded before and after EndoPredict® results were revealed to the multidisciplinary team. RESULTS: 233 patients were recruited across five sites: 123 consecutive and 110 at clinical team discretion. In the consecutive cohort 50.6% (62/123) cases were classified high risk of recurrence by EndoPredict®, compared with 62.7% (69/110) in the selective cohort. A change in treatment recommendation was significantly more likely (p < 0.0001) in the selective cohort (43/110, 39.1%) compared to the consecutive group (11/123, 8.9%). The strongest driver of selective recruitment was intermediate grade histology, whilst logistic regression modelling demonstrated that nodal status (p < 0.001), proliferative rate (p = 0.001), and progesterone receptor positivity (p < 0.001) were the strongest discriminators of risk. CONCLUSION: Whilst molecular risk can be predicted by traditional variables in a high proportion of cases, EndoPredict® had a greater impact on treatment decisions in those cases selected for testing at team discretion. This is indicative of the robust ability of the clinical team to identify cases most likely to benefit from testing, underscoring the value of genomic tests in the oncologists' tool kit.

Cancer sleep symptom-related phenotypic clustering differs across three cancer specific patient cohorts.

Specific sleep disorders have been linked to disease progression in different cancers. We hypothesised sleep symptom clusters would differ between cancer types. The aim of this study was to compare sleep symptom clusters in post-treatment melanoma, breast and endometrial cancer patients. Data were collected from 124 breast cancer patients (1 male, 60 ± 15 years, 28.1 ± 6.6 kg/m2 ), 82 endometrial cancer patients (64.0 ± 12.5 years, 33.5 ± 10.4 kg/m2 ) and 112 melanoma patients (59 male, 65.0 ± 18.0 years, 29.1 ± 6.6 kg/m2 ). All patients completed validated questionnaires to assess sleep symptoms, including the Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Snoring, tiredness, observed apneas, age, BMI, and gender data were also collected. Binary values (PSQI, ISI, FOSQ), or continuous variables for sleepiness (ESS) and perceived sleep quality (PSQI), were created and sleep symptom clusters were identified and compared across cancer cohorts. Four distinct sleep symptom clusters were identified: minimally symptomatic (n = 152, 47.7%); insomnia-predominant (n = 87, 24.9%); very sleepy with upper airway symptoms (n = 51, 16.3%), and severely symptomatic with severe dysfunction (n = 34, 11.1%). Breast cancer patients were significantly more likely to be in the insomnia predominant or severely symptomatic with severe dysfunction clusters, whereas melanoma patients were more likely to be minimally symptomatic or sleepy with upper airway symptoms (p <0.0001). Endometrial cancer patients were equally distributed across symptom clusters. Sleep symptom clusters vary across cancer patients. A more personalised approach to the management of sleep-related symptoms in these patients may improve the long term quality of life and survival.

Lessons Learned in Implementing Patient-Reported Outcome Measures (PROMs) in the Australian Breast Device Registry (ABDR).

BACKGROUND: The Australian Breast Device Registry (ABDR) is a clinical quality registry which utilizes both surgical data and patient-reported outcome measures (PROMs) to understand device performance. The ABDR is the first national breast device registry utilizing the BREAST-Q Implant Surveillance module to conduct PROMs via text messaging as the primary method of contact for most patients. ABDR PROMs are structured upon a successful acceptability and feasibility study and a pilot study. OBJECTIVES: This aim of this paper was to examine the challenges we faced and consider how lessons learned in implementing PROMs might inform future registry studies and interventions. METHODS: We tracked the number of completed follow-ups and documented feedback between October 2017 and December 2018 from various stakeholders, including sites, surgeons, and patients. RESULTS: In total, 10,617 patients were contacted: 59% of breast augmentation and 77% breast reconstruction patients responded to our PROMs survey. We encountered challenges and developed solutions to overcome several key issues, including database setup; follow-up contact methods; ethics; education of surgeons and patients; associated costs; and ongoing evaluation and modification. The strategies we devised to address these challenges included drawing on experiences from previous studies, greater communication with sites and surgeons, and having the flexibility to improve and modify our PROMs. CONCLUSIONS: The ABDR PROMs experience and lessons learned can inform a growing number of registries seeking to conduct PROMs. We describe our approach, obstacles encountered, and strategies to increase patient participation. As more breast device registries worldwide adopt PROMs, data harmonization is crucial to better understand patient outcomes and device performance.

Identification of Predictive Factors for Patient-Reported Outcomes in the Prospective Australian Breast Device Registry.

BACKGROUND: Patient-reported outcome measures (PROMs) are an important tool for evaluating outcomes following breast device procedures and are used by breast device registries. PROMs can assist with device monitoring through benchmarked outcomes but need to account for demographic and clinical factors that may affect PROM responses. OBJECTIVES: This study aimed to develop appropriate risk-adjustment models for the benchmarking of PROM data to accurately track device outcomes and identify outliers in an equitable manner. METHODS: Data for this study were obtained from the Australian Breast Device Registry, which consists of a large prospective cohort of patients with primary breast implants. The 5-question BREAST-Q implant surveillance module was used to assess PROMs at 1 year following implant insertion. Logistic regression models were used to evaluate associations between demographic and clinical characteristics and PROMs separately by implant indication. Final multivariate risk-adjustment models were built sequentially, assessing the independent significant association of these variables. RESULTS: In total, 2221 reconstructive and 12,045 aesthetic primary breast implants with complete 1-year follow-up PROMs were included in the study. Indication for operation (post-cancer, risk reduction, or developmental deformity) was included in the final model for all reconstructive implant PROMs. Site type (private or public hospital) was included in the final breast reconstruction model for look, rippling, and tightness. Age at operation was included in the reconstruction models for rippling and tightness and in the aesthetic models for look, rippling, pain, and tightness. CONCLUSIONS: These multivariate models will be useful for equitable benchmarking of breast devices by PROMs to help track device performance.

Breast cancer treatment and survival differences in women in remote and socioeconomically disadvantaged areas, as demonstrated by linked data from New South Wales (NSW), Australia.

INTRODUCTION: Reducing variations in cancer treatment and survival is a key aim of the NSW Cancer Plan. Variations in breast cancer treatment and survival in NSW by remoteness and socioeconomic status of residence were investigated to determine benchmarks. Reducing variations in cancer treatment and survival is a key aim of the NSW Cancer Plan. Variations in breast cancer treatment and survival in NSW by remoteness and socioeconomic status of residence were investigated to determine benchmarks. METHODS: A retrospective cohort study used linked data for invasive breast cancers, diagnosed in May 2002 to December 2015 from the NSW Cancer Registry, with corresponding inpatient, and medical and pharmaceutical insurance data. Associations between treatment modalities, area socioeconomic status and residential remoteness were explored using logistic regression. Predictors of breast cancer survival were investigated using Kaplan-Meier product-limit estimates and multivariate competing risk regression. RESULTS: Results indicated a high 5-year disease-specific survival in NSW of 90%. Crude survival was equivalent by residential remoteness and marginally lower in lower socioeconomic areas. Competing risk regression showed equivalent outcomes by area socioeconomic status, except for the least disadvantaged quintile, which showed a higher survival. Higher sub-hazard ratios for death occurred for women with breast cancer aged 70 + years, and more advanced stage. Adjusted analyses indicated more advanced stage in lower socioeconomic areas, with less breast reconstruction and radiotherapy, and marginally less hormone therapy for women from these areas. Conversely, among these women who had breast conserving surgery, there was higher use of chemotherapy. Remoteness of residence was associated in adjusted analyses with less radiotherapy and less immediate breast reconstruction. In these short term data, remoteness of residence was not associated with lower survival. CONCLUSION: This study provides benchmarks for monitoring future variations in treatment and survival.

Implementing a prospective surveillance and early intervention model of care for breast cancer-related lymphedema into clinical practice: application of the RE-AIM framework.

PURPOSE: Chronic lymphedema following breast cancer (BC) affects individuals physically, functionally, psychologically, and financially. Despite national guidelines and evidence-based research supporting a prospective surveillance and early intervention model of care (PSM), bridging the gap between research and clinical practice has been difficult. METHOD: As part of an international randomized controlled trial (RCT), Australian women with BC from four hospitals were recruited, monitored for lymphedema at regular intervals over a 3-year period, and were provided a compression garment if intervention was triggered. The reach, effectiveness, adoption, implementation and maintenance (RE-AIM) evaluation framework was used retrospectively to assess a PSM at the individual and organizational level for those who had completed at least 2-year follow-up (N = 219) in the RCT. RESULTS: The application of the RE-AIM framework retrospectively demonstrated an extensive reach to patients across public and private settings; the effectiveness of prospective surveillance and early intervention was achieved through low progression rates to clinical lymphedema (1.8%), and all hospital sites initially approached adopted the research study. Key implementation strategies necessary for effectiveness of this model of care included education to health professionals and patients, staff acceptability, and development of a referral and care pathway. Maintenance dimensions were evaluated both at the individual level with 92-100% adherence rates for all nonoptional study appointments over the 2-year period, and at the organizational-level, PSM was sustained after recruitment ceased for the research study. CONCLUSION: The PSM for lymphedema in BC can be successfully implemented using the RE-AIM framework applied retrospectively. The implementation of the PSM used in the RCT has assisted in changing clinical practices and improving the quality and effectiveness of the health care system.