[Show abstract][Hide abstract] ABSTRACT: 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.
We evaluated the usefulness of the PERFORM scale to measure fatigue in a large study focusing exclusively on anemic patients.
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).
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.
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.
Full-text · Article · Jun 2013 · Supportive Care in Cancer
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
The PQ measured the attitudes and beliefs about fatigue among cancer patients in clinical practice and showed good psychometric properties among Spanish-speaking patients.
Full-text · Article · May 2011 · Supportive Care in Cancer
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
The newly developed questionnaire, which measures the impact of cancer-related fatigue on oncology patients, has shown satisfactory feasibility, reliability and validity.
[Show abstract][Hide abstract] ABSTRACT: Background: Cancer-related fatigue is gaining importance as an outcome measure. Perform Questionnaire (PQ) is a recently developed and validated scale for the assessment of perceptions about chronic renal failure (CRF). The minimally important difference (MID) that implies a clinically meaningful outcome has been determined to enable better interpretation of the observed numerical differences in PQ. Methods: In an observational, longitudinal, multicentre study in cancer patients with CRF, data (demographics, haemoglobin (Hb) levels, and HRQoL measures (PQ and FACT-F) were collected at inclusion and 3 months later. An Hb increase of 1g/dL was considered as the minimally important clinical change by which to evaluate HRQoL results. ‘Improved’ patients were those who experienced an increase in Hb1g/dL. ‘Stable’ patients had a change in Hb<1g/dL to a lower limit of -1g/dL. The difference in the mean HRQoL change score between the two groups was the MID of the measurement; MID was determined for PQ and FACT-F. Results: In total, 288 patients were included; 34.6% had breast cancer, 12% colon cancer, 12% lung cancer; 28.4% had anaemia (Hb<11g/dL). At 3 months, 87 patients (30.2%) improved while 201 (69.8%) remained stable; the difference in mean change in Hb level between stable and improved patients was 2.09g/dL. Pearson’s correlation between Hb level and PQ score at baseline was 0.24. Conclusions: MID can be useful to help interpret HRQoL score changes. An improvement of approximately 4 and 3 in PQ and FACT-F, respectively, can be considered as MIDs when an Hb1g/dL is seen as the minimally important clinical change.
[Show abstract][Hide abstract] ABSTRACT: Background: CRF is a frequently reported complaint in cancer patients and survivors. There are scales available to measure the intensity, frequency and duration of CRF but there are few scales to assess patient perceptions and beliefs about CRF. The recently developed PQ attempts to fill this need. This study aims to validate the new measure. Methods: An observational and longitudinal multi- centre study was carried out on a sample of cancer patients with CRF. Data were collected at inclusion and 3 months later. The PQ was administered, as well as the FACT-F and Nottingham Health Profile (NHP) health measures, at both visits. Sociodemographic data, key clinical indicators, fatigue intensity (by means of a visual analogue scale) and self-rated stability for patient health status were also collected. Viability, reliability (internal consistency and test-retest) and validity were assessed for the PQ. Results: 431 patients were included in the study: 60.2% women, mean age 58.9 years, mean time since diagnosis 2.21 years 31.0% with breast cancer, 54.9% with metastatic disease, Karnofsky mean score 80.9, 28.8% with anaemia. Answering the PQ was considered moderately easy to very easy for 80.7% of patients. Answering the questionnaire took less than 10 minutes for 76.3% of the sample. Overall and dimension internal consistency were high (Cronbach alpha = 0.93 range 0.80–0.89). Test-retest reliability for overall score (intra-class correlation coefficient (ICC) = 0.81) and dimension scores (range 0.59–0.77) were also good in patients without changes in health status. The PQ had a stronger correlation with FACT (r=0.82) than with NHP (r=0.71), a moderate correlation with fatigue intensity (r=0.43), and low correlation with Karnofsky (r=0.26). Patients requiring third party care had a worse overall score for the PQ than patients who did not (30 vs. 37; p<0.0001), while patients with anaemia showed a worse health- related quality of life than patients without anaemia (31.7 vs. 36.4; p<0.0001). Conclusions: The PQ has demonstrated good reliability and validity for assessing patient perception of CRF in the study sample. Additional research is needed to obtain further insight into how the PQ performs with specific cancer populations.
[Show abstract][Hide abstract] ABSTRACT: To date, the clinical features and outcomes of patients with initially metastatic breast carcinoma (IMBC) have not been compared with the corresponding characteristics in patients with recurrent metastatic breast carcinoma (RBC). This issue may be particularly relevant to clinical research, as it may shed light on a potential bias with respect to the selection of patients for clinical trials.
A retrospective analysis of the medical records of 1350 patients with breast carcinoma was performed. Outcome variables included overall survival, response rate, and progression-free survival.
One hundred nineteen of 370 patients with metastatic breast carcinoma had IMBC, whereas the remaining 251 had RBC. The median follow-up duration was 39.4 months, and the median overall survival duration was 24 months. With regard to clinical characteristics, patients with IMBC were older than patients with RBC (61.7 years vs. 58.1 years; P < 0.001) and had a higher incidence of lobular carcinoma (15.9% vs. 7.7%; P = 0.018), a greater proportion of T3-4 tumors (58.8% vs. 27.9%; P < 0.001), a higher incidence of bone as the dominant metastatic site (41.2% vs. 21.5%; P < 0.001), a lower incidence of soft tissue as the dominant metastatic site (10.1% vs. 26.7%; P < 0.001), and a similar incidence of the viscera as the dominant metastatic site (48.7% vs. 51.8%; P = 0.78). Median overall survival duration was similar for patients with IMBC (25.1 months) and patients with RBC (23.3 months; P = 0.81). Statistical analyses also revealed nonsignificant differences between patients with IMBC and patients with RBC in terms of response rate (40.7% vs. 35.2%, respectively; P = 0.35) and median progression-free survival duration (10.2 months vs. 9.0 months, respectively; P = 0.58).
Although patients with IMBC and patients with RBC exhibit distinct histologic and clinical characteristics, similar treatment efficacy results and survival outcomes are observed in these two groups.
[Show abstract][Hide abstract] ABSTRACT: Currently employed high-dose regimens for patients with breast carcinoma consist mainly of single-cycle combinations of alkylating agents. In a previous Phase I trial, the authors developed a tandem high-dose combination of two cycles of mitoxantrone and cyclophosphamide for the treatment of patients with metastatic breast carcinoma (MBC) and high-risk breast carcinoma (HRBC). Treatment was delivered with granulocyte-colony stimulating factor (G-CSF) but without stem cell support to avoid potential tumor cell reinfusion. The objective was to validate the safety and obtain preliminary efficacy assessment of this combination in a Phase II trial.
Fifty-three patients were included: 27 patients with MBC and 26 patients with HRBC. After standard induction treatment, patients received two cycles of mitoxantrone 25 mg/m2 and cyclophosphamide 4000 mg/m2 separated by a 4-week interval. Patients received G-CSF and ciprofloxacin until hematologic recovery. Follow-up was performed in an outpatient setting.
One hundred one of 106 projected cycles (95%) were delivered. The mean dose intensities achieved were mitoxantrone 5.8 mg/m2 per week and cyclophosphamide 933 mg/m2 per week. Infection developed in 46% of the cycles, and platelet transfusions were required in 42%. Nonhematologic toxicity was mainly Grade 3 emesis. There were no toxic deaths. In 17 evaluable patients with MBC, 13 patients (77%) had response improvements, including 7 complete responses (41%).
Treatment with two cycles of mitoxantrone 25 mg/m2 and cyclophosphamide 4000 mg/m2 with G-CSF but without stem cell support was well tolerated. The dose intensities achieved approach those obtained with conventional high-dose therapy. This combination warrants further investigation as an alternative to conventional high-dose regimens.
[Show abstract][Hide abstract] ABSTRACT: This phase I study was designed to develop a high-dose combination of two cycles of mitoxantrone and cyclophosphamide in patients with solid tumors, as an alternative to single-cycle high-dose regimens that use only alkylating agents. Treatment was delivered with granulocyte colony-stimulating factor (G-CSF), but without stem cell support, in order to avoid potential tumor cell reinfusion. Thirty-one patients with advanced solid tumors received two cycles of high-dose mitoxantrone (20-30 mg/m2) plus high-dose cyclophosphamide (3000-4000 mg/m2). All patients received G-CSF until hematologic recovery. Dose-escalation was performed when less than 50% of cycles per level had dose-limiting toxicity (DLT). The maximum tolerated dose (MTD) achieved was mitoxantrone 25 mg/m2 and cyclophosphamide 4000 mg/m2. Main dose-limiting toxicities (DLTs) were hematological: grade IV neutropenia lasting more than 7 days and thrombopenia below 20 x 10(9)/l requiring more than one platelet transfusion. Non-hematological DLT consisted predominantly of grade III emesis and asthenia. Follow-up after each cycle was performed in an outpatient setting and there were no toxic deaths. In conclusion, the administration of two cycles of high-dose mitoxantrone and cyclophosphamide with G-CSF support is safe and feasible. MTD was mitoxantrone 25 mg/m2 and cyclophosphamide 4000 mg/m2. Evaluation of this regimen is being done in a phase II trial.
Full-text · Article · Feb 2001 · Bone Marrow Transplantation