Totally implantable venous access ports systems for patients receiving chemotherapy for solid tissue malignancies: A randomized controlled clinical trial examining the safety, efficacy, costs, and impact on quality of life.

PURPOSE: To examine the safety, efficacy, costs, and impact on quality of life of venous access ports implanted at the outset of a course of intravenous cancer chemotherapy. PATIENTS AND METHODS: Adults beginning a course of intravenous chemotherapy at two university-affiliated hospitals were randomly allocated to have venous access using a surgically implanted venous access port (Port-a-Cath; Pharmacia, Canada Inc, Montreal, Québec, Canada) or using standard peripheral venous access. All accesses were documented by number, route, purpose, and procedure duration. Outcome measurements included port complications, access strategy failure, access-related anxiety and pain, quality of life (Functional Living Index-Cancer [FLI-C]), and costs. RESULTS: Port complication rates were low (0.23/1,000 days). Failure occurred in two (3.4%) of 59 port subjects and 16 (26.7%) of 60 controls (P =. 0004) at a median period of 26 days after randomization (95% confidence interval, 8 to 92). Peripheral accesses in port subjects took less time, had less access-related anxiety and pain, and were less costly to perform than in controls. Allocation had no effect on FLI-C scores. Peripheral access failure correlated with allocation to the control group (P =.007), higher pain scores with intravenous (IV) starts (P =.003), and anxiety with IV starts (P =.01). Venous accessing overall in port patients was four times more costly than that in controls ($2,178/patient v $530/patient, respectively). CONCLUSION: Ports were safe and effective but had no detectable impact on functional quality of life, despite less access-related anxiety, pain, and discomfort. Because only approximately one quarter of control patients ultimately required central venous access, economic considerations suggest that port-use policies should be based upon defined criteria of need.

Information needs of husbands of women with breast cancer.

PURPOSE/OBJECTIVES: To identify and measure the information needs of the husbands of women newly diagnosed with breast cancer and to determine the extent to which these needs are being met. DESIGN: Descriptive survey. SETTING: Five surgical inpatient units at four urban hospitals in Winnipeg, Manitoba, Canada. SAMPLE: 84 husbands of women recently diagnosed with breast cancer. METHOD: Subjects completed the Family Inventory of Needs--Husbands. MAIN RESEARCH VARIABLES: Information needs and extent to which these needs were met. FINDINGS: Husbands' highest ranked needs were those related to immediate care needs and communication issues. Their lowest ranked needs were those related to family relationship issues and their practical involvement in caring for their spouse. No differences existed between type of surgery (lumpectomy versus mastectomy) and number of needs and whether or not needs were met. However, husbands whose wives had undergone their first mastectomy reported approximately three times more unmet needs than husbands whose wives had undergone previous surgery for breast cancer. Husbands at greatest risk for not having their needs met were those whose occupational classification was listed as retired or laborers, those with less than a high school education, and those whose wives had only undergone one surgery for breast cancer. CONCLUSIONS: Results of this study provide a profile of the husbands' most and least important information needs and the degree to which these important needs were met. IMPLICATIONS FOR NURSING PRACTICE: With a clearer idea of the type of information important to husbands of women with breast cancer, intervention studies to determine how to best address these information needs can be designed.

Measuring the information needs of husbands of women with breast cancer: validity and reliability of the Family Inventory of Needs--husbands.

PURPOSE/OBJECTIVES: A two-phase study was undertaken to test the Family Inventory of Needs--Husbands (FIN-H), a tool designed to measure the information needs of husbands of women with breast cancer and the extent to which these needs are met. DESIGN: Methodologic survey. SAMPLES: Phase I: a panel of 6 husbands; phase II: 84 husbands of women with breast cancer. METHODS: Panel of expert ratings followed by pilot test of the two-part survey. FINDINGS: In phase I, husbands assessed the FIN-H for clarity, internal consistency, and content validity. All preset criteria were met. In phase II, internal consistency, test-retest reliability, and internal validity were assessed. Internal consistency estimates as measured by Cronbach's standardized alpha coefficients were 0.91 and 0.93. Test-retest correlations were 0.82 and 0.76 (p = 0.0001). Exploratory factor analysis suggested that the FIN-H consists of five factors. CONCLUSIONS: Initial results suggest that the FIN-H is reliable and valid. Further testing is needed to confirm these results. IMPLICATIONS FOR NURSING PRACTICE: Before nurses can address the information needs of husbands of women with breast cancer, use of a reliable and valid assessment tool is recommended.

Therapy of untreated acute myeloid leukemia in the elderly: remission-induction using a non-cytarabine-containing regimen of mitoxantrone plus etoposide.

PURPOSE: The University of Manitoba Adult Acute Leukemia Study Group sought to examine the safety, efficacy, and impact on quality of life of a non-cytarabine-containing remission-induction regimen followed by intermediate-dose cytarabine (IDARA-C) postremission therapy for the management of untreated acute myeloid leukemia (AML) in patients age 60 to 80 years. PATIENTS AND METHODS: Eligible patients received mitoxantrone 10 mg/m2 and etoposide 100 mg/m2 on days 1 to 5. Complete remitters received a single course of cytarabine 0.5 mg/m2 every 12 hours on days 1 to 6. Cytogenetic and immunophenotyping studies were performed at diagnosis and were examined for prognostic importance. The Functional Living Index-Cancer (FLI-C) was used in the longitudinal assessment of quality of life. RESULTS: A total of 37 (55%) of 67 eligible patients achieved remission, 34 (92%) of whom did so with a single course. The induction mortality rate was 12%. The median disease-free and overall survival times were 8.4 and 9.2 months, respectively. CD34 stem-cell phenotype, poor performance status, and high cytogenetic complexity score were independent covariates of failure to achieve remission. Very complex karotype combined with CD34 stem-cell phenotype to predict induction death in 67% of cases (P = .0003). Cytotoxic therapy-related gut epithelial damage was maximal during weeks 2 and 3 of therapy. Complete remitters and partial responders exhibited significantly improved global FLI-C scores following completion of therapy. CONCLUSION: Mitoxantrone plus etoposide was an effective and well-tolerated first-line induction regimen for AML in the elderly that should be studied further in comparison to the standard cytarabine/anthracycline-based therapy.

Acute myeloid leukemia in Manitoba. The consequences of standard "7 + 3" remission-induction therapy followed by high dose cytarabine postremission consolidation for myelosuppression, infectious morbidity, and outcome.

BACKGROUND: To the authors' knowledge, the natural history of myelosuppression and infectious complications associated with the use of standard cytarabine (ARA-C) plus daunorubicin ("7 + 3") remission-induction therapy for adult acute myeloid leukemia (AML) and high dose ARA-C (HDARA-C) consolidation has not been described completely. METHODS: A retrospective study of untreated adult AML patients receiving standard 7 + 3 induction followed by "5 + 2" and HDARA-C consolidation was undertaken to describe the relationship of the myelosuppression profiles, blood product use, and infectious morbidity, and to correlate this finding with the outcome of antileukemic therapy. Multivariate techniques were used to evaluate variables of prognostic importance. RESULTS: Fifty-nine percent of the patients achieved remission after a median of 35 days; almost half (48%) of these patients required more than one 7 + 3 induction course. For one, two, and three induction courses, the mean number of days the patients experienced severe neutropenia (< 0.5 x 10(9)/l) were 22.5 +/- 10.9, 39.3 +/- 14.3, and 47.4 +/- 9.7 days (P < 0.001), respectively, and the infection rates were 1.45, 2.45, and 3 infections per course (P < 0.0001), respectively. The pattern of blood product use was similar. HDARA-C consolidation was the most significant factor related to prolonged disease free survival, however the myelosuppression profiles and infection rates were surprisingly similar to those for the single 7 + 3 induction courses. CONCLUSIONS: The 7 + 3 induction regimen used in this center provided only limited antileukemic activity, while requiring multiple induction courses in a high proportion of patients. The use of multiple induction courses had consequences of prolonged myelosuppression, increased blood product use, and incremental risks of infectious complications. HDARA-C consolidation for those who experienced complete remission appeared to improve disease free survival with myelosuppression comparable with that of patients who received primary induction therapy. The infection risk was acceptable, with only a marginal increase in bacteremic and fungal infections.