Development and Evaluation of a Patient-Reported Outcome (PRO) Scale for Breast Cancer

Background: This study was guided by principles of the theoretical system of evidence-based medicine. In particular, when searching for evidence of breast cancer, a measuring scale is an instrument for evaluating curative effects in accordance with the laws and characteristics of medicine and exploring the establishment of a system for medically assessing curative effects. At present, there exist few tools for evaluating curative effects. Patientreported outcomes (PROs) refer to outcomes directly reported by patients (without input or explanations from doctors or other intermediaries) with respect to all aspects of their health. Data obtained from PROs provide evidence of treatment effects. Materials and Methods: In accordance with the tenets of theoretical medicine and ancient medical theory regarding breast cancer, principles for developing a PRO scale were established, and a theoretical model was developed and a literature review was performed, items from this pool were combined and split, and an initial scale was constructed. After a pilot survey and additional modifications, a pre-questionnaire scale was formed and used in a field investigation. After the application of statistical methods, the item pool was used to create a formal scale. The reliability, validity and feasibility of this formal scale were then assessed. Results: In a clinical investigation, 479 responses were recovered, with an acceptance rate of 95%. a combination of various methods was employed, and the items that were selected by all methods or more than half of the methods were employed in the questionnaire. In these cases, the screening methods were combined with certain features of the item, A total of four domains and 38 items were reserved. The reliability analysis indicated that the PRO scale was relatively reliable. Conclusions: Scientific assessment proved that the proposed scale exhibited good reliability and validity. This scale was readily accepted and could be used to assess the curative effects of medical therapy. However, given the limited scope of this investigation, the capacity for adapting this scale to incorporate other theories could not be determined.     

Profiling the Psychological Training and Support Needs of Oncology Staff,and Evaluating the Effectiveness of a Level 2 Psychological Support Training Program Workshop

The importance of training non-psychology healthcare professionals to offer psychological support to people with cancer is becoming increasingly recognized. This small-scale pilot project sought to identify the training and support needs of oncology staff and to evaluate the effectiveness of a Level 2 Psychological Support Training Program workshop. Semi-structured interviews with five members of multidisciplinary oncology staff identified that training needs were primarily around communication skills, recognizing and dealing with emotions, offering support and empathy, and self-care. Pre and post-training questionnaires developed with these themes in mind revealed that the Level 2 Training Program workshops run in this network of hospitals are effective in increasing participants’ levels of perceived knowledge and confidence across each of these domains. Recommendations are made for further enhancing this effectiveness.     

Evaluation of Patient-Reported Outcome Differences by Radiotherapy Techniques for Bone Metastases in A Population-Based Healthcare System

We assessed whether advanced RT techniques were associated with differences in patient-reported outcomes (PROs). Patients with bone metastases who completed the brief pain inventory (BPI) before and after RT were identified, and RT technique was categorized as simple (e.g., parallel opposed pair) or advanced (e.g., 3D-conformal RT (3DCRT), intensity-modulated RT (IMRT), or stereotactic ablative RT (SABR)). Pain response and patient-reported interference on quality of life secondary to pain was compared. A total of 1712 patients completed the BPI. From 2017–2021, the rate of advanced RT technique increased significantly (p < 0.001; 2.4%, 2.4%, 9.7%, 5.5%, 9.3%), with most advanced techniques consisting of IMRT, and only 7% of advanced techniques were SABR. Comparing simple vs. advanced technique, neither the complete pain response (12.3% vs. 11.4%; p = 0.99) nor the partial pain response (50.0% vs. 51.8%; p = 0.42) was significantly different. There was no significant patient-reported difference in pain interfering with general activity, mood, walking ability, normal work, relationships, sleep, or enjoyment of life. Given that there is increasing utilization of advanced RT techniques, there is further need for randomized trials to assess their benefits given the increased cost and inconvenience to patients.     

Recruiting Adolescent and Young Adult Cancer Survivors for Patient-Reported Outcome Research: Experiences and Sample Characteristics of the SURVAYA Study

Background: Participation of Adolescents and Young Adults with cancer (AYAs: 18–39 years at time of diagnosis) in patient-reported outcome studies is warranted given the limited knowledge of (long-term) physical and psychosocial health outcomes. We examined the representativeness of AYAs participating in the study, to observe the impact of various invitation methods on response rates and reasons for non-participation. Methods: A population-based, cross-sectional cohort study was performed among long-term (5–20 years) AYA cancer survivors. All participants were invited using various methods to fill in a questionnaire on their health outcomes, including enclosing a paper version of the questionnaire, and sending a reminder. Those who did not respond received a postcard in which they were asked to provide a reason for non-participation. Results: In total, 4.010 AYAs (response 36%) participated. Females, AYAs with a higher socio-economic status (SES), diagnosed more than 10 years ago, diagnosed with a central nervous system tumor, sarcoma, a lymphoid malignancy, stage III, or treated with systemic chemotherapy were more likely to participate. Including a paper questionnaire increased the response rate by 5% and sending a reminder by 13%. AYAs who did not participate were either not interested (47%) or did want to be reminded of their cancer (31%). Conclusions: Study participation was significantly lower among specific subgroups of AYA cancer survivors. Higher response rates were achieved when a paper questionnaire was included, and reminders were sent. To increase representativeness of future AYA study samples, recruitment strategies could focus on integrating patient-reported outcomes in clinical practice and involving AYA patients to promote participation in research.     

Assessing the Financial Toxicity of Radiation Oncology Patients Using the Validated Comprehensive Score for Financial Toxicity as a Patient-Reported Outcome

PurposeThe financial burden of cancer care may significantly affect patient quality of life and clinical outcomes. However, the financial effect of radiation therapy on patients remains difficult to characterize, in part owing to the lack of standardized methods to measure patient distress related to treatment costs. Here, we assessed financial burden in the radiation oncology population by applying the Comprehensive Score for Financial Toxicity (COST), a patient-reported outcome measure, which has been validated in medical oncology patients. Methods and MaterialsConsecutive patients from a single academic radiation oncology clinic were recruited. Participants completed the 11-item COST-Functional Assessment of Chronic Illness Therapy questionnaire, with total possible scores ranging from 0 to 44. Scores were collected along with data regarding patient demographics, insurance, diagnosis, and treatment. Univariate and multivariate analyses were performed to identify factors associated with higher financial burden as measured by COST.ResultsA total of 167 patients completed the COST questionnaire. Lower COST scores indicated higher financial toxicity. The population’s mean COST score was 21.9 (95% confidence interval, 20.5-23.3). Fifteen percent of participants reported grade 2 to 3 COST toxicity, corresponding to a moderate or severe effect on quality of life. Use of concurrent or previous systemic therapy was significantly associated with lower COST scores on univariate analysis (P = .03), but not significant on multivariate analysis. A subset analysis of posttreatment follow-up patients identified rural residence and recent completion of radiation therapy as significant correlates of worse COST scores on univariate analysis, and rural residence remained independently associated on multivariate analysis (P = .017).Conclusions COST effectively identified a significant number of radiation oncology patients experiencing financial toxicity, indicating its prevalence in this population. A correlate of financial toxicity in this population is the use of systemic therapy. Of those who have completed radiation therapy, rural residence was independently associated with worse financial toxicity.     

Conception and Associated Evaluation of a Problem-Solving Training (PST) for Patients in the Hospital Context of Hematopoietic Stem Cell Transplantation (HSCT)

It appears from empirical studies that the problem-solving ability of patients is associated with the experience of distress and the patients’ mental state. The goals of this study were the (1) conception and (2) associated evaluation of the psychological short-time intervention “problem-solving training” (PST) for patients hospitalized for hematopoietic stem cell transplantation (HSCT).

(1) The conception of the PST comprised a multi-stage development phase. An existing manual for outpatients diagnosed with cancer was adapted to the specific situation of a HSCT. This was followed by development of a manual, definition of the general framework, instruction of coaches, and implementation in a hospital setting.

(2) The associated evaluation of PST was conducted from the patients’ and the coaches’ point of view. A total of 22 patients and five coaches evaluated the training.

The training was evaluated by both patients and coaches as being well achievable with the exception of a limited time frame for the first module. The manual explanations were judged to be intelligible by all participants. Regarding on-topic alertness, patients were, on average, rated as “rather “to “very attentive.” The patients evaluated the response to their needs as “good.” They further assessed their overall condition due to the training as “good.”

This study provides preliminary evidence for the feasibility of PST by using the developed manual (Psychological Short-Term Intervention PST for Patients During HSCT). Based on this, it is conceivable to implement this intervention in similar situations to the advantage of a different patient clientele.     

癌症患者生命质量测定量表体系之宫颈癌量表QLICP-CE的研制及考评

[目的]研制癌症患者生命质量测定量表体系之宫颈癌量表QLICP-CE,并对其进行考评.[方法]通过程序化决策方式并多轮的访谈和预调查等研制量表QLICP-CE.并通过对92例宫颈癌患者的测定进行评价.统计学方法包括相关分析、因子分析和配对t检验等.[结果]该量表的重测信度y为0.95,克朗巴赫系数为0.68;相关分析与因子分析显示较好的结构效度;治疗后除社会功能领域外各领域及总量表得分均有统计学意义.治疗前后基本上能够反映出生命质量的变化.[结论]QLICP-CE具有较好的信度、效度及反应度,可以用于中国宫颈癌患者的生命质量测定.     

Patient-Reported Outcomes Data From REVEAL at the Time of Enrollment (Baseline): A Prospective Observational Study of Patients With Polycythemia Vera in the United States

Background

Patients with polycythemia vera (PV) often experience symptoms that adversely affect their quality of life (QoL). The ongoing, prospective, observational REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices) study was designed to collect contemporary data regarding burden of disease, clinical management, patient-reported outcomes (PROs), and health care resource utilization from adult patients with PV in the United States.

Breast Cancer Survivor Advocacy at a University Hospital: Development of a Peer Support Program with Evaluation by Patients,Advocates, and Clinicians

Peer-to-peer support programs provide unique psychosocial and educational support for breast cancer patients. A Patient Survivor Advocacy (PSA) program was developed by the University of Wisconsin Breast Center (UWBC) to provide support for newly diagnosed patients from peers who had completed primary treatment. In this study, we evaluated patient, advocate, and clinician experience with the PSA program. A program matching volunteer peer advocates at least 1 year removed from primary treatment with newly diagnosed patients was developed. Peer advocates were recruited from the practices of UWBC clinicians and received in-person training on six dimensions of peer advocacy. Trained advocates were then paired based on demographic and medical history with new patients referred to the program. Survey assessment tools were distributed to assess peer advocate and patient satisfaction, as well as clinician experience. Forty patients have been matched with seven advocates, with contact largely by email (53 %) or phone (36 %). Patients and peer advocates reported satisfaction with the program. The majority of patients (92.9 %) reported that the program was “helpful” and that they would recommend the PSA program to another woman with breast cancer. All peer advocates (100 %) responded with a sense of achievement in their advocate roles. Clinicians noted challenges in referral to the program. Peer advocates can provide key emotional and psychosocial support to newly diagnosed breast cancer patients. The peer advocate, patient, and clinician feedback collected in this study will inform the future development of this program at our and peer institutions.     

Report from the Radiation Oncology Committee of the Southwest Oncology Group (SWOG): Research Objectives Workshop 2003

To achieve the ultimate goal of cancer treatment, which is 100% cancer control with negligible toxicity, the therapeutic window must be enlarged, allowing for higher doses of beneficial treatments with reduced toxicity. The advent of image- and metabolism-guided therapy offers the best opportunity to date for combining modern radiation targeting and imaging techniques. Indeed, for the first time, it is reasonable to locally target metastatic disease with the goal of sterilization. Combining these focal radiation techniques with novel targeted antiproliferative agents and full-dose classic cytotoxic chemotherapy will become more effective as we learn to use these compounds in a less systemically toxic manner and as radiation fields become more defined. In addition, increasing numbers of biologic modifiers of normal tissue response are becoming available, and they suggest great promise for decreasing the normal tissue toxicity resulting from both radiation and chemotherapy treatments. Thus, radiation metastectomy for gross metastases, used together with systemic control of micrometastatic disease, may yield improved survival rates. This hypothesis is ready for testing in cancers of the breast, prostate, colon, and in sarcomas. Enlarging the therapeutic window is a major goal that would allow for an increasingly favorable therapeutic gain.     

社会支持与不同性别癌症患者发病的关系研究

目的 :探讨社会支持与不同性别癌症患者发病的关系 ;方法 :使用肖水源编制的“社会支持评定量表”分别对5 0 1例不同性别癌症患者进行问卷调查 ;结果 :女性患者社会支持总分、主观支持分和对支持的利用度的评分比男性患者高(P <0 0 5 ) ,而客观支持分两者无差异 ;结论 :社会支持与不同性别癌症患者发病相关 ;应给癌症发病高危人群、特别是男性多一些关爱 ;而患者自身应充分利用别人的帮助 ,以促进心理和身体健康     

Feasibility Assessment of Using the Complete Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library

The patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) complements capture of symptomatic adverse events (AEs) by clinicians. Previous trials have typically used a limited subset of relevant symptomatic AEs to reduce patient burden. We aimed to determine the feasibility of administering all 80 AEs included in the PRO-CTCAE library by approaching consecutive patients enrolled in a large academic phase I program at three points in time. Here, we report a preplanned analysis after enrolling the first 20 patients. All items were answered on 51 of 56 potential visits (adherence 91%). Three (5%) additional PRO-CTCAE assessments were partially completed, and two (4%) were missed because of conflicting appointments. No patient withdrew consent or chose not to complete the assessments once enrolled on study. Future trials of experimental drugs that incorporate the PRO-CTCAE should consider using this unselected approach to identify adverse events more completely.     

Radioguided Intraoperative Margins Evaluation (RIME): Preliminary results of a new technique to aid breast cancer resection

Aims

Women undergoing breast-conserving surgery for cancer can present residual disease. We have developed a technique called Radioguided Intraoperative Margins Evaluation (RIME) that uses a radiopharmaceutical to distinguish normal and cancer tissues. The aim of this study was to assess whether RIME is a feasible technique, and if it could help in breast cancer resection with free margins, minimizing residual disease.

Methods

Twenty-three breast cancer patients programmed for mastectomy were selected. Before surgery, the patients were submitted to scintimammography with ^99mTc-sestamibi to estimate the optimal time to begin radioguided surgery. Twenty patients were submitted to magnetic resonance imaging (MRI), to evaluate skin, deep fascia and to detect other tumor foci. At the beginning of the surgery, the same dose of ^99mTc-sestamibi was intravenously injected into patients. Tumor resection was performed under guidance of a gamma-probe, characterizing the RIME technique. Finally, modified radical mastectomy was performed. Tumor and residual breast were histopathologically examined.

Results

The RIME technique was successfully performed in all patients. The principal tumor was removed by this technique and provided 82.6% of histologically free margins (mean margins, 4.8 mm). Additionally, 47.8% of patients were without residual disease. The mean size of residual carcinoma was 3.67 mm and generally located near the tumor bed (<1.5 cm). There was no significant association between presence of residual disease and tumor size or margin status.

Conclusion

RIME is a feasible technique that could help tumor resection with free margins; however, it seems to be limited for small carcinoma foci.     

The Continuing Umbrella of Research Experiences (CURE): A Model for Training Underserved Scientists in Cancer Research

Mentoring is a critical aspect of research and training; and the adoption of a successful mentoring model for guiding researchers through the educational pipeline is lacking. The Continuing Umbrella of Research Experiences (CURE) program was established in the Comprehensive Minority Biomedical Branch; which is part of the National Cancer Institute. This program offers unique training and career development opportunities to enhance diversity in cancer research. The CURE initiative focuses on broadening the cadre of underserved investigators engaging in cancer research. CURE begins with high school students and fosters scientific, academic and research excellence throughout the trainee’s educational progression. The program supports students throughout the entirety of their training career. During this period, the trainee matures into a competitive early stage investigator; capable of securing advanced research project funding in academic and industry workforces. Thus, the CURE program provides a comprehensive vehicle for training and reinforces the critical mass of underserved investigators conducting cancer research.