Establishing an Expert Consensus on Key Indicators of the Quality of Life among Breast Cancer Survivors: A Modified Delphi Study.

(1) Background: The needs of cancer survivors are often not reflected in practice. One of the main barriers of the use of patient-reported outcomes is associated with data collection and the interpretation of patient-reported outcomes (PROs) due to a multitude of instruments and measuring approaches. The aim of the study was to establish an expert consensus on the relevance and key indicators of quality of life in the clinical practice of breast cancer survivors. (2) Methods: Potential indicators of the quality of life of breast cancer survivors were extracted from the established quality of life models, depicting survivors' perspectives. The specific domains and subdomains of quality of life were evaluated in a two-stage online Delphi process, including an international and multidisciplinary panel of experts. (3) Results: The first round of the Delphi process was completed by 57 and the second by 37 participants. A consensus was reached for the Physical and Psychological domains, and on eleven subdomains of quality of life. The results were further supported by the additional ranking of importance of the subdomains in the second round. (4) Conclusions: The current findings can serve to optimize the use of instruments and address the challenges related to data collection and interpretation as the facilitators of the adaption in routine practice.

Usefulness of the PERFORM questionnaire to measure fatigue in cancer patients with anemia: a prospective, observational study.

BACKGROUND: The PERFORM Questionnaire is a 12-item scale developed for assessing fatigue in cancer patients in the clinical practice. It has advantages over other tools in that it is short and includes beliefs and attitudes of patients about fatigue. It was psychometrically validated in cancer patients with and without anemia. PURPOSE: We evaluated the usefulness of the PERFORM scale to measure fatigue in a large study focusing exclusively on anemic patients. METHODS: This was an observational, multicenter, prospective, 3-month study in cancer patients with hemoglobin (Hb)≤11 g/dl. Fatigue was assessed using the PERFORM questionnaire. The overall score ranges from 12 (no fatigue) to 60 (maximum fatigue). RESULTS: We included 667 patients: 54.1 % women, mean age 60 (standard deviation, 12) years. A highly significant, but mild correlation was observed between low baseline Hb and high patient perception of fatigue (r with PERFORM score=-0.215, p < 0.0001). Of the patients, 65.8 % improved Hb level during follow-up (increase of ≥1 g/dL and/or achieving >11 g/dL), which translated into a significant improvement in the PERFORM score [mean (95 % confidence interval (CI)] change, -1.2 (-0.04 to -2.4), whereas more fatigue was observed in patients without improvement in Hb [change (95 % CI) in PERFORM, +3.3 (1.5 to 5)]. In a multivariate linear regression analysis, the independent factors associated to fatigue at 3 months were a low Hb level, a low Karnofsky index, active chemotherapy, cancer treatment with palliative intention, and transfusion need in the last 3 months. CONCLUSIONS: Minimal increases or decreases in Hb of ≥1 g/dL were associated with meaningful changes in patient-perceived fatigue as measured with the PERFORM questionnaire. In addition to anemia severity, other factors such as active chemotherapy and advanced disease contribute to perception of fatigue by cancer patients.

Psychometric properties of the Perform Questionnaire: a brief scale for assessing patient perceptions of fatigue in cancer.

PURPOSE: Fatigue is a symptom with a relevant impact on the daily lives of cancer patients and is gaining importance as an outcome measure. The Perform Questionnaire (PQ) is a new scale originally developed among Spanish-speaking patients for the assessment of perception and beliefs about fatigue in cancer patients. METHODS: An observational longitudinal multicenter study was carried out on cancer patients with fatigue. Fatigue-specific measures (FACT-F), generic health-related quality-of-life measures (NHP), and PQ were gathered at baseline and 3 months later. Feasibility, reliability (internal consistency and test-retest), validity, sensitivity to change, and minimally important differences were analysed. RESULTS: Four hundred thirty-seven patients were included in the study: 60.5% were women, the mean age was 59.1 years, the mean time from diagnosis was 2.2 years, 33.6% of patients had breast cancer, and 29.1% had anaemia (haemoglobin (Hb) <11 g/dL). Low levels of missing items and ceiling/floor effects (<10%) were found. The overall Cronbach's alpha and intraclass correlation coefficient were 0.94 and 0.83, respectively. The PQ score was associated with fatigue intensity, the need for a caregiver, and the Hb level. Its association was stronger with the FACT-F than with non-specific health measures (NHP). The PQ showed good sensitivity to change for improved and worsening health status. A minimally important difference of 3.5 was estimated in patients whose Hb level had improved by at least 1 g/dL. CONCLUSIONS: The PQ measured the attitudes and beliefs about fatigue among cancer patients in clinical practice and showed good psychometric properties among Spanish-speaking patients.

Development of a new questionnaire to assess patient perceptions of cancer-related fatigue: item generation and item reduction.

OBJECTIVES: Existing instruments that measure the impact of cancer-related fatigue on health-related quality of life do not usually incorporate the attitudes, beliefs and perspectives of patients. This study aimed to develop an instrument to measure the impact of cancer-related fatigue on the health-related quality of life of cancer patients. METHODS: Items were generated from a literature review, focus groups of cancer patients and meetings with oncologists. Potential items were administered to cancer patients to facilitate item reduction, which was based on clinimetric and psychometric analyses and qualitative criteria. A preliminary assessment of feasibility, reliability and validity of the retained items was performed. RESULTS: An initial pool of 75 items was administered to 238 cancer patients. Fifty items were eliminated after statistical analysis and 13 in response to expert opinion, resulting in a provisional instrument with 12 items in 3 dimensions. These displayed acceptable internal consistency (Cronbach's alpha, 0.78-0.92) and their overall score was associated with fatigue intensity, extent of disease, intention of treatment and need of caregivers. CONCLUSION: The newly developed questionnaire, which measures the impact of cancer-related fatigue on oncology patients, has shown satisfactory feasibility, reliability and validity.

Advanced breast cancer: chemotherapy phase III trials that change a standard.

At the present time, there is not a standard regimen in upfront metastatic setting for breast cancer. A wide variety of regimens which includes anthracyclines, taxanes, gemcitabine or capecitabine are currently used, however, there is evidence to support the use of many of these drugs in early breast cancer and consequently limiting their use in first line treatment. The aim of this review is to evaluate every randomized phase III trials conducted in first line metastatic breast cancer. For this reason, all randomized studies that evaluated the role of chemotherapy in advanced breast cancer were analyzed and classified according to their protocol design. So far, sixteen major randomized clinical trials have evaluated the role of chemotherapy as front line in metastatic breast cancer. Some of them have analyzed a different anthracyclines-based regimen as the control arm versus new combinations or new drugs. In others, the aim is to evaluate the most effective therapy after progression to an adjuvant anthracyclines-containing regimen. The suitability of the control arm, the prospective definition of patient's subgroups as well as the statistical methodology have been taken into account.