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Subgroups of patients with cancer with different symptom experiences and quality-of-life outcomes: a cluster analysis.

PURPOSE/OBJECTIVES: To identify subgroups of outpatients with cancer based on their experiences with the symptoms of fatigue, sleep disturbance, depression, and pain; to explore whether patients in the subgroups differed on selected demographic, disease, and treatment characteristics; and to determine whether patients in the subgroups differed on two important patient outcomes: functional status and quality of life (QOL). DESIGN: Descriptive, correlational study. SETTING: Four outpatient oncology practices in northern California. SAMPLE: 191 outpatients with cancer receiving active treatment. METHODS: Patients completed a demographic questionnaire, Karnofsky Performance Status scale, Lee Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies Depression Scale, Multidimensional Quality-of-Life Scale Cancer, and a numeric rating scale of worst pain intensity. Medical records were reviewed for disease and treatment information. Cluster analysis was used to identify patient subgroups based on patients symptom experiences. Differences in demographic, disease, and treatment characteristics as well as in outcomes were evaluated using analysis of variance and chi square analysis. MAIN RESEARCH VARIABLES: Subgroup membership, fatigue, sleep disturbance, depression, pain, functional status, and QOL. FINDINGS: Four relatively distinct patient subgroups were identified based on patients experiences with four highly prevalent and related symptoms. CONCLUSIONS: The subgroup of patients who reported low levels of all four symptoms reported the best functional status and QOL. IMPLICATIONS FOR NURSING: The findings from this study need to be replicated before definitive clinical practice recommendations can be made. Until that time, clinicians need to assess patients for the occurrence of multiple symptoms that may place them at increased risk for poorer outcomes.

Aged↗

Variables for predicting serious toxicity (vinblastine dose, performance status, and prior therapeutic experience): chemotherapy for metastatic testicular cancer with cis-dichlorodiammineplatinum(II), vinblastine, and bleomycin.

Combination chemotherapy utilizing high-dose vinblastine, bleomycin, and cisdichlorodiammineplatinum(II) (CDDP) is effective treatment for metastatic testicular cancer. Unfortunately, it is frequently associated with serious toxicity. In a series of 14 patients receiving 65 treatment cycles, several variables were examined as putative risk factors for prediction of serious toxicity. These included drug dose normalized to body weight or surface area, interval since previous cycle, prior therapeutic experience with either radiation therapy or other cytotoxic chemotherapy, and Karnofsky performance status. The strongest determinant of serious toxicity was the vinblastine dose calculated according to body weight. The next most influential prognostic variables were the performance status and a history of previous treatment with either radiation therapy or chemotherapy. Serious toxicity may be anticipated at a frequency of 40% when vinblastine is administered at a total dose of 0.36 mg/kg with bleomycin and CDDP. In our group of patients, the nephrotoxicity of CDDP appeared to be cumulative despite intensive diuresis at the time of administration. Pulmonary toxicity was not observed. Modest reductions in vinblastine dose, especially in patients with poor performance status or a history of previous radiation or other chemotherapy, will substantially lower the frequency of serious toxicity.

Adolescent↗

Prospective validation of a pharmacologically based dosing scheme for the cis-diamminedichloroplatinum(II) analogue diamminecyclobutanedicarboxylatoplatinum.

We previously correlated both renal function and thrombocytopenia, the dose limiting toxicity of carboplatin, with the plasma pharmacokinetics of carboplatin. From these correlations, we developed equations to calculate carboplatin dosage for any patient based on that patient's creatinine clearance, body surface area, pretreatment platelet count, desired platelet nadir, and status of prior chemotherapy. We prospectively applied these equations in 44 courses of carboplatin given to 24 patients. There were 13 males and 11 females with median age 53 (range, 33-77), median Karnofsky performance status 80 (range, 50-100), and creatinine clearance 32 to 118 ml/min. Ten patients had creatinine clearances less than 60 ml/min. Precision of the equations used for dose calculation was evaluable in 38 courses administered to 23 patients. In 23 courses of carboplatin administered to 12 patients without extensive prior chemotherapy, the observed change in platelets = 1.04 X predicted change -48,000 (r = 0.96). In the 15 courses of carboplatin administered to 11 heavily pretreated patients, the observed change in platelets = 1.13 X predicted change +6,600 (r = 0.97). For the overall combined population, the observed change in platelets = 0.96 X predicted change -7,000 (r = 0.94). These relationships which nearly define the line of identity (observed = expected) validate our initial observations. Only 2 patients developed WBC less than 2,000, but 12 patients developed hematocrit less than or equal to 29% and 8 required RBC transfusions. Fifteen patients had nausea and vomiting greater than or equal to grade 2. There were no other nonhematological toxicities observed. In view of continuing documentation of the antitumor activity of carboplatin, these equations allow safe and rational drug dosing of patients with potentially platinum-responsive tumors but with renal function too poor to receive cisplatin. Among the 9 patients in this study evaluable for response, there was 1 partial response in a patient with malignant melanoma and 1 objective response (less than partial response) in a patient with adenocarcinoma of the cervix.

Blood Cell Count↗

Usefulness of strontium-89 for bone pain palliation in metastatic breast cancer patients.

Most studies of prostate cancer have shown that strontium-89 chloride (89Sr) is effective in the palliation of metastatic bone pain, refractory to conventional analgesia. The aim of this study was to evaluate the usefulness of 89Sr for bone pain palliation in breast cancer patients. Forty women were treated with 148 MBq of 89Sr. Six patients were retreated, receiving two or more doses. The Karnofsky performance status was assessed and pain and analgesia were scored on scales of 9 and 5 points, respectively. The efficacy of 89Sr was evaluated at 3 months of treatment. The response was good in 60% of the patients and partial in 32%; there was no response in the remaining 8% (pre-treatment Karnofsky < or = 60). The duration of the response was 120+/-143 days. In the patients retreated, the response was good in 83% and partial in 17%, without significant differences compared with the first dose, but the pre-treatment Karnofsky and the duration of the efficacy were lower (P < 0.05). A transient and slight decrease of leukocyte and platelet counts after the first month of treatment with 59Sr was observed. In conclusion, breast cancer patients with metastatic bone pain can benefit from therapy with 89Sr. If necessary, the treatment may be repeated safely and with the same efficacy as is achieved after the first dose. A low functional performance status could be a cause of the lower effectiveness of 89Sr.

Aged↗

Weekly docetaxel and estramustine in patients with hormone-refractory prostate cancer.

The combination of docetaxel and estramustine has exhibited synergistic activity both in prostate cancer cell lines and in patients with hormone-refractory prostate cancer (HRPC). Based on these promising preclinical and phase I/II data, we conducted a study of weekly docetaxel and estramustine in patients with metastatic HRPC and a poor performance status. A total of 30 patients received (1) a 3-day course of oral estramustine during weeks 1 and 2 of each 3-week cycle plus (2) docetaxel, 35 mg/m(2) intravenously on day 2 of weeks 1 and 2. The median number of cycles per patient was 5, ranging from 1 to 22. The median patient age was 74 years (range, 61 to 90 years), and the median baseline Karnofsky performance status was 60% (range, 50% to 80%). Twenty-three patients (76%) had a > or =50% decrease in serum prostate-specific antigen (PSA); 17 (56%) of these patients had a > or =75% decrease in PSA. Pain scores and performance status likewise improved in 70% of patients. Three complete responses and four partial responses were observed among 12 patients with measurable disease. Toxicities were primarily nonhematologic in nature, with the most common being grade 1 through 3 nausea, asthenia, diarrhea, and edema. Given the activity and tolerability of weekly docetaxel and estramustine in this study, this regimen appears to be more suitable than previously studied docetaxel/estramustine administration schedules for treating metastatic HRPC in elderly patients with a poor performance status.

Adenocarcinoma↗

Physical and psychosocial outcomes in cancer patients: a comparison of different age groups.

In a cross-sectional study, we investigated the relationship between age, physical health, social and economic resources, functional status, activities of daily living (ADL) and disease-related variables of 227 patients with cancer. Using multidimensional outcome measures we examined age differences in three age groups (< 45, 46-65, > 65 years) and identified predictors of performing ADL. The results indicated that older patients have outcomes similar to those of younger patients. There were no significant differences in quality of life, performance status and physical health among the three age groups. The only areas where age-related differences were found were co-morbidity and cancer-related impairments. Patients aged 45-65 years and patients 65 years and older reported a higher level of co-morbidity and more cancer-related impairments than those aged 45 and younger. Although older patients had higher co-morbidity, they showed similar Karnofsky Performance Status (KPS) scores to those of their younger counterparts. The regression analysis revealed social resources, self-reported health, performance status and complexity of care as significant predictors of patients' ADL, but not age, co-morbidity or severity of treatment. The findings support the conclusion that differences in performing ADL between younger and older patients with cancer are minimal and tend to be due to co-morbidity. Thus, treatment should be decided by a patient's physical health rather than by age.

Activities of Daily Living↗

Prognostic factors for loco/regional control and metastasis and the impact on survival.

For the identification of predictive factors for local (head and neck) control and metastases and impact on survival in squamous cell cancer of the head and neck, we have used data from over 2000 patients from the Patterns of Care Study (PCS) and the Radiation Therapy Oncology Group (RTOG) studies. Complete local response (C.R.) is significantly related to T stage, N stage, general performance status (Karnofsky), and site of primary tumor. There is a strong association between T and N stage. T1N0 tumors showed a C.R. of 99%, whereas, T1N3 had a C.R. of 57%. T4N0 showed a C.R. of 75%, but this went down to 31% in the T4N3 lesions. Glottic tumors showed a C.R. of 96% versus the other sites, which ranged from 81% for the nasopharynx to 59% for the hypopharynx. Patients with a performance status (KPS) of less than 90% showed a C.R. of 60% versus 88% for AKPS 90% or higher. Absence of local recurrence after C.R. is significantly related to T stage, N stage, and the site of primary tumor (glottis versus the rest). The appearance of distant metastases is significantly related only to N stage and primary site. This relationship persists in control of loco/regional tumors. In Stages III & IV in non-glottic head and neck cancer, metastases as the cause of death play an increasingly important role. This can be as high as 30%. The appearance of new malignant tumors and death unrelated to cancer, that is, death related to lifestyle, assumes an important role in patients with advanced head and neck cancer. The number of advanced glottic larynx was too small to examine this question. The use of a surgical procedure in carcinomas of the anterior tongue and floor of the mouth was associated with a smaller percentage of infield recurrences at 2 years, than when radiation therapy alone was used (27% versus 88% p less than .01). The same observation was noted at 3 years in the glottic and supraglottic Stage III & IV tumors (p less than .01).

Carcinoma, Squamous Cell↗

The Edmonton Functional Assessment Tool: preliminary development and evaluation for use in palliative care.

The purpose of this article is to report the development and psychometric testing of the Edmonton Functional Assessment Tool (EFAT). The EFAT was developed as a functional outcome measure for use with a palliative care population. The assessment identified ten functional activities important to patients even in the terminal stage of their illness. In addition, a global performance status rating (PS) asked for an overall judgment of functional status after the ten EFAT functions were evaluated. Tests for interrater reliability and concurrent validity were conducted on a sample of 25 inpatients on the Palliative Care Unit (PCU) at the Edmonton General Hospital (EGH) who were evaluated independently by two raters. Interrater reliability of the EFAT expressed as an intraclass correlation (ICC) was established at 0.88. The interrater reliability of these two raters was 0.71 for the Karnofsky Performance Status (KPS) and 0.81 for the performance status measure of the Eastern Cooperative Oncology Group (ECOG). Concurrent validity of the EFAT was demonstrated by correlating the total EFAT score with the KPS (r = -0.79, P = 0.0001) and the ECOG (r = 0.85, P = 0.0001). The total EFAT score was also strongly correlated with the global PS rating scale (r = 0.90, P = 0.0001). Construct validity of the EFAT was tested with a sample of 101 patients admitted to the unit, which was later divided into the unit group (N = 88) and the home group (N = 13). Our findings provided initial evidence that the EFAT distinguished between the functional status of these two groups. The results of this preliminary study suggest that the EFAT requires further research and development, but shows potential to evolve as a useful clinical tool in palliative care.

Aged↗

Moderate chemo-radiotherapy in non-small cell lung cancer: results in 21 patients with advanced disease and low performance status.

Twenty-one patients with advanced non-small cell lung cancer and low performance status (Karnofsky: 40-60) were treated with moderate doses of chemo-radiotherapy. Seven patients (33%) had partial response and a median survival time of 10 months; 5 patients (24%) had stable disease and a median survival time of 5 months; 9 patients (43%) had progression of disease and a median survival time of 6 months. Median survival time for the whole group was 7 months. Toxicity related to treatment was minimal and posttreatment performance status was: stable in 10 patients and improved in 5 responsive patients. We conclude that this therapeutic strategy has some efficacy in this category of patients although it failed to show substantial benefit in terms of survival.

Adenocarcinoma↗

Quality of life and utility in irradiated laryngeal cancer patients.

PURPOSE: To determine quality of life (QOL) and health utility in irradiated laryngeal cancer survivors. MATERIALS AND METHODS: Over 6 months, consecutive follow-up patients at a comprehensive cancer centre completed the QOL questionnaire FACT-H&N and the time trade-off (TTO) utility instrument. RESULTS: Inclusion criteria were met by 339 patients, of whom 269 were eligible, 245 were approached, and 120 agreed to participate. Most participants were men (83%) who had received radiotherapy (97%) for Stage I disease (53%) of the glottis (75%); 7% had undergone total laryngectomy. Participants differed from nonparticipants only in being younger (mean age, 65 vs. 68 years, p = 0.0049) and having higher performance status (Karnofsky 88 vs. 84, p = 0.0012). The average scores for FACT-H&N and the TTO were 124/144 (SD, 14) and 0.90/1.0 (SD, 0.16) respectively. FACT-H&N score was more highly correlated with Karnofsky score (r = 0.43, p = 0.001) than with the TTO (r = 0.29, p = 0.002). Gender predicted QOL (means: M = 125, F = 118), while natural speech, no relapses, and more time since initial treatment predicted higher utility. CONCLUSION: The QOL of irradiated laryngeal cancer survivors was reasonably high and independent of initial disease variables. The QOL questionnaire correlated more strongly with performance status than with utility, suggesting that QOL and utility measures may be perceived differently by patients.

Aged↗

Impairment in functional status and survival in patients with acute myeloid leukaemia.

Acute myeloid leukaemia (AML) is mainly affecting elderly patients. Elderly patients are increasingly affected by impairment of functional status (FS). FS is of prognostic relevance for survival in different tumours. Data for patients with AML are rare. Within a prospective trial we recruited patients with newly diagnosed AML and measured FS by two different methods: Karnofsky performance status (KPS) and instrumental activities of daily living (IADL). Sixty-three patients aged 19-85 years (median 61.1) were included. Twenty-three had prior myelodisplastic syndrome (MDS), 7 favourable, 17 unfavourable karyotype. Fifty received induction chemotherapy, 13 palliative chemotherapy. Median survival was 15.2 months (95% CI, 10.8-22.3) in all patients. Age, cytogenetic risk group, and impaired KPS and IADL significantly influenced median survival in univariate analysis. Impairment of IADL was the single most predictive variable. In multivariate analysis, impairment of IADL Score (HR:4.3, 95% CI 1.7-10.5, P = 0.001) and of KPS (HR:4.8, 95% CI 1.9-12.3, P = 0.001), and unfavourable cytogenetic risk group (HR:6.0, 95% CI 2.5-14.3, P < 0.001) significantly predicted median survival. In patients with AML, FS and not age is a major predictor of survival. The influence of FS is independent from cytogenetic risk group. IADL measurement adds information to KPS. The results have to be confirmed in a large sample of patients.

Activities of Daily Living↗

Carboplatin-based chemotherapy in patients with advanced non-small cell lung cancer and a poor performance status.

BACKGROUND: Poor performance status patients with advanced non-small cell lung cancer (NSCLC) have frequently been excluded from clinical trials due to the perception that they would have excessive treatment-related toxicity and a limited life expectancy. METHODS: A retrospective review of two multicenter trials centered at the University of North Carolina of patients who were treated with platinum-based chemotherapy for advanced NSCLC was conducted. Patients were divided into two subgroups based on Karnofsky performance status (KPS). Patients with a KPS = 70 were considered to have poor performance status, while patients with a KPS > or =80 were considered to have good performance status. RESULTS: Of the 387 patients, 19% (n = 73) had a poor performance status. The response rate (complete and partial responses) was similar between the two sub-groups (26% versus 28%); however, there was a difference in survival (p = 0.0004, log-rank test) between the groups. The median survival and 1-year survival rate for the poor performance status patients was 4.9 months and 21%, while the good performance status patients had a median survival of 8.4 months and a 1-year survival rate of 31%. The rate of National Cancer Institute (NCI) Common Toxicity Criteria (CTC) toxicities was similar between the two groups (p = 0.33). The percentage of patients receiving <4 cycles of therapy in the poor and good performance status was 55 and 39%, respectively (p = 0.012). CONCLUSIONS: Patients with poor performance status treated with platinum based chemotherapy have a similar rate of toxicity compared to good performance status patients. Their overall survival was lower despite a similar response to chemotherapy.

Antineoplastic Agents↗

Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced biliary carcinoma.

PRECIS: UFT 300 mg/m2/day and leucovorin 90 mg/day could be administered safely to patients with advanced biliary cancer with good performance status; however, this combination and schedule of 28-day administration has no activity in this disease. PURPOSE: To determine the activity and evaluate the toxicity of uracil and tegafur in a 4:1 molar concentration ratio (UFT; Bristol-Myers Squibb, Wallingford, CT) plus oral calcium leucovorin in the treatment of patients with advanced biliary (gallbladder and bile duct) carcinoma. PATIENTS AND METHODS: Thirteen patients with advanced measurable biliary carcinoma were enrolled onto the trial. All patients had a Karnofsky performance status > or = 60%, platelet count > or = 75,000/microL, total bilirubin < or = 2.0x institutional upper limit of normal but otherwise normal liver and kidney function profile and bidimensionally measurable disease by CT scan or ultrasound examination. None of these patients previously received cytotoxic chemotherapy or radiation therapy for advanced disease. Patients received 300 mg/m2/d UFT plus 90 mg/d leucovorin administered orally in divided daily doses every 8 hours for 28 days repeated every 35 days. Objective tumor response, the primary endpoint of this trial, was evaluated after two courses of therapy. Other endpoints included toxicity, time to progression, and overall survival. RESULTS: All patients were evaluable for response and toxicity. No complete or partial responses were observed in this trial. Four patients had stable disease lasting 17, 30, 33, and 35 weeks, respectively. The median (range) time to progression and survival were 9 (1-35) and 28 (1-61) weeks, respectively. Treatment-related toxicity was mild with severe (grade 3 or 4) diarrhea seen in 2 (15%). Grade 3-4 hyperbilirubinemia (31%) and nausea/vomiting (31%) were observed and likely related to the underlying disease. Grade 1 and 2 toxic effects included mainly anorexia and fatigue. CONCLUSION: UFT 300 mg/m2/d plus oral leucovorin 90 mg/d administered for 28 days repeated every 35 days is ineffective in the treatment of advanced biliary carcinoma.

Aged↗

The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer.

PURPOSE: The purpose of this study was to develop and validate an instrument for clinical trials to measure radiation-related acute morbidity and quality of life from the perspective of patients with head and neck cancer (HNC) treated with radiotherapy. METHODS: The Head and Neck Radiotherapy Questionnaire (HNRQ) was developed by a panel of health care workers and patients, was pretested in a pilot study of HNC patients, and was validated in a randomized double-blind trial of concomitant fluorouracil (FUra) infusional therapy (1.2 g/m2 per 24 hours) or saline placebo administered for 72 hours in the first and third weeks of a 6 1/2-week course of radiation therapy. The HNRQ was validated against existing toxicity and performance status indices, all of which were measured weekly for the 6 1/2 weeks of treatment and for 4 weeks posttreatment. RESULTS: There were three a priori constructs: (1) that the HNRQ scores would conform to a shallow U-shaped pattern to reflect declining quality of life (increasing morbidity) during radiation and recovery posttreatment; (2) that the HNRQ would correlate with existing toxicity indices (World Health Organization [WHO] stomatitis, Byfield stomatitis, WHO skin toxicity, Eastern Cooperative Oncology Group [ECOG] and Karnofsky performance status); and (3) that the HNRQ would discriminate between FUra and placebo groups. The HNRQ and its domain scores all showed a change from baseline reflecting increased morbidity during radiation (analysis of variance [ANOVA], P < .00001). The HNRQ correlated well with all other indices (r > or = .60), and domain scores correlated best with other indices that assess the same symptom complex (eg, HNRQ skin domain and WHO skin toxicity index, r = .77). There was a significant difference in HNRQ scores between the FUra and placebo groups during radiation (ANOVA, P = .0007), and all HNRQ domains also discriminated between the treatment groups. CONCLUSION: The HNRQ is a valid measure of acute morbidity due to radiation therapy in patients with locally advanced HNC, and may be useful as an outcome measure for future clinical trials of radiation treatment strategies.

Carcinoma, Squamous Cell↗

Effect of nursing interventions on nutritional and performance status in cancer patients.

Cancer patients, assessed as nutritionally at risk, were randomly assigned to a control group or to one of four intervention groups receiving (a) nutritional supplementation, (b) relaxation training, (c) both nutritional supplementation and relaxation training, or (d) neither nutritional supplementation nor relaxation training. Fifty-five subjects completed a four-month intervention period during which they were visited biweekly by a nurse (except control subjects). In repeated measures analyses of variance, significant group-by-time interactions were obtained for weight and arm muscle circumference (a measure of protein stores), indicating that for these measures the groups changed differentially during the intervention period. The group-by-time interaction approached significance on the Karnofsky Performance Status Scale. For all three variables, gain was greatest for the relaxation group; the most severe loss occurred in the control group. These findings suggest that the cachexia of cancer may be slowed or reversed through noninvasive nursing interventions.

Activities of Daily Living↗

The role of cryosurgery in palliation of tracheo-bronchial carcinoma.

OBJECTIVE: Carcinoma of the lung is the commonest cause of death from malignant disease in humans. At diagnosis, about 85% of patients are in an advanced stage of the disease and approximately 30% present with a tumour blocking a large bronchial lumen, causing distressing and life threatening symptoms. Early reopening and treatment of the blocked airways is required to improve symptoms and quality of life. There are a number of methods available to achieve this aim including cryotherapy, the controlled application of extreme cold. METHODS: We present a prospective study of 153 consecutive patients, cryotreated between January 1995 and December 1997 with a mean age of 68.8 years and a male:female ratio of 1.59:1. The procedure can be performed under general or local anaesthetic using a rigid or flexible cryoprobe. A temperature of about - 70 degrees C is delivered to the tumour site for two 3-min periods causing destruction of the tumour mass. Patients were evaluated clinically and for performance status before and after treatment. Histological composition was: non-small cell 88.2%, small cell 11.1% and malignant melanoma 0.7%. The TNM staging for NSC patients, at the time of treatment was stage II 8.2%, IIIa 27.4%, IIIb 25.9%, IV 38.5%. RESULTS: Subjective symptomatic improvement for cough was 68.3%, dyspnoea 63.9%, haemoptysis 92.7% and chest pain 55.5%. Respiratory function tests showed improvements in mean FEV1 from 1.34 l to 1.45 l (P = 0.001) and mean FVC from 1.93 to 2.02 l (P = 0.035). The Karnofsky performance status increased by 54.6%. Kaplan-Meier median survival time was 12.9 months. Complications were found with 11 patients (7.2%) and there was no operative mortality. CONCLUSIONS: Cryotherapy provides effective and rapid control of symptoms caused by tracheobronchial carcinoma and improves quality of life and survival. It is easy to perform, with minimum complications and the majority of patients are discharged the same day.

Adult↗

The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity.

BACKGROUND: The goal of this investigation was to examine the relationship between, and application of, two disease specific quality of life (QL) measures currently being employed for head and neck cancer patients: the Functional Assessment of Cancer Therapy-Head and Neck Scale (FACT-H&N) and the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN). METHODS: The FACT-H&N and PSS-HN were administered to 151 head and neck cancer patients with a range of disease sites, treatment status (on vs. off treatment), and treatment modalities (surgery, radiation, and chemotherapy). RESULTS: FACT-H&N subscale and total scores and PSS-HN subscale scores proved sensitive to patients groups (showed significant and clinically meaningful differences) on the basis of treatment status (on vs. off treatment) and global performance status (Karnofsky scores). The pattern of correlations between FACT-H&N and PSS-HN subscales supported the scales' construct (convergent vs. divergent) validity. The strongest and most significant associations were observed between PSS-HN Normalcy of Diet and Eating in Public, and the head and neck subscale (HNS) of FACT-H&N, both of which were designed to measure the unique problems of head and neck cancer patients. More modest associations were observed between subscales measuring physical and functional areas of performance, social functioning, and emotional well-being. CONCLUSIONS: The FACT-HNS was found to be reliable and valid when applied to head and neck cancer patients. It clearly adds information to that collected by the parent (core) instrument. The PSS-HN also provides unique information, independent of that provided by the Karnofsky or the FACT-H&N. This study supported the multidimensional nature of QL for head and neck cancer patients, and thus the importance of assessing disease specific concerns in addition to general health status when assessing functional and QL outcome.

Adolescent↗

Objective evaluation of physical function in patients with advanced lung cancer: a preliminary report.

PURPOSE: This prospective study was designed in order to compare the most common subjective measurements of physical function in patients with advanced lung cancer with an objective physical functional test (Simmonds Functional Assessment Tool [SFA]). PATIENTS AND METHODS: One hundred patients agreed to participate and complete the study before or after their outpatient medical oncology appointment. Patients underwent assessment using the Karnofsky, the Brief fatigue Inventory, The Functional Assessment of Cancer Therapy-Lung patients (FACT-L) and the Edmonton Symptom Assessment Scale (ESAS). These results were compared to the SFA tool. The SFA consists of six tasks: tying a belt, putting coins in a cup, reaching above head, standing up/sitting down, reaching forward and walking 50 feet. RESULTS: Ninety-nine patients completed the study over 8 months: median Karnofsky performance status was 85 (70 to 100), Edmonton Symptom Assessment Scale (ESAS) score (0 to 10) was generally low (0.5 to 2.8). SFA scores were significantly different in patients compared to a control group. The correlation between the subscales of the SFA and the Karnofsky, the Brief Fatigue Inventory, The FACT-L and the ESAS was generally low to moderate (r values: 0.22 to 0.38). There was generally a moderate correlation between the different subjective scales (r values: 0.3 to 0.62). CONCLUSION: Adherence to the SFA tool was excellent. The low to moderate correlation between the abnormalities found in the objective SFA and the subjective fatigue tests suggest that objective evaluation of the functional capacity provides a potentially useful and independent end-point for clinical trials and therapeutic interventions. These assessment tools should be used complementary to each other to better assess the functional status of patients with advanced lung cancer. Large trials of objective functional assessment are justified.

Adult↗