Psychometric Testing of the Pap Smear Belief Questionnaire: Measuring Women's Attitudes and Beliefs Toward Cervical Cancer Screening.

BACKGROUND AND PURPOSE: Some women avoid routine Pap testing because of negative attitudes and beliefs. The ability to measure these factors is limited by lack of valid and reliable tools. Therefore, this article describes steps taken to test a measure. METHODS: Validity and reliability testing of psychometric scales was conducted. RESULTS: Sample consisted of 344 women. Using principal component analysis resulted in 4 components: Exam-Related Factors, Benefits, Vulnerability, and Risks and Barriers. Revised scale included 28 items explaining 46% variance, with good internal consistency (α = .84). Women who did not routinely screen exhibited significantly more negativity. CONCLUSIONS: The measure demonstrates validity and reliability across different groups of women and can be used to inform the design of individualized interventions to promote repeat screening.

An Investigation of Depression, Trauma History, and Symptom Severity in Individuals Enrolled in a Treatment Trial for Chronic PTSD.

OBJECTIVE: To explore how factors such as major depressive disorder (MDD) and trauma history, including the presence of childhood abuse, influence diverse clinical outcomes such as severity and functioning in a sample with posttraumatic stress disorder (PTSD). METHOD: In this study, 200 men and women seeking treatment for chronic PTSD in a clinical trial were assessed for trauma history and MDD and compared on symptom severity, psychosocial functioning, dissociation, treatment history, and extent of diagnostic co-occurrence. RESULTS: Overall, childhood abuse did not consistently predict clinical severity. However, co-occurring MDD, and to a lesser extent a high level of trauma exposure, did predict greater severity, worse functioning, greater dissociation, more extensive treatment history, and additional co-occurring disorders. CONCLUSION: These findings suggest that presence of co-occurring depression may be a more critical marker of severity and impairment than history of childhood abuse or repeated trauma exposure. Furthermore, they emphasize the importance of assessing MDD and its effect on treatment seeking and treatment response for those with PTSD.

A preliminary investigation of sudden gains in exposure therapy for PTSD.

The purpose of the current study was to examine sudden gains in those receiving treatment for PTSD and whether these rapid changes were related to overall symptom reduction in a small sample of female assault survivors with PTSD undergoing prolonged exposure (PE) therapy. Sudden gains were found to occur in 52% of the sample. Among those who experienced a sudden gain, the average magnitude (12.4 points) accounted for 61% of overall symptom reduction. Importantly, treatment outcome was better for those who experienced sudden gains than those who did not. The experience of a sudden gain may result in patients becoming more fully engaged with treatment, and recognition of them may result in identifying potential process-related predictors of treatment response.

Phase II trial of gemcitabine/carboplatin (plus trastuzumab in HER2-positive disease) in patients with metastatic breast cancer.

BACKGROUND: Gemcitabine and carboplatin have significant preclinical synergy, and both provide synergistic antitumor activity in metastatic breast cancer (MBC) when used in combination with trastuzumab. The gemcitabine/ cisplatin combination is highly active in MBC with response rates (RRs) of approximately 50% in anthracycline- and taxane-pretreated patients and up to 80% in untreated subjects. This phase II trial studied the efficacy and safety of gemcitabine/carboplatin with or without trastuzumab in patients with MBC. PATIENTS AND METHODS: Patients were stratified into 3 groups: group 1, HER2-positive; group 2, HER2-negative and taxane- naive/remote (no taxanes within past 2 years); and group 3, HER2-negative and previous taxane therapy. Included were women aged > or = 18 years, Eastern Cooperative Oncology Group performance status of 0-2, with Response Evaluation Criteria in Solid Tumors-defined measurable MBC; HER2-negative or HER2 (3+) by immunohistochemistry or fluorescence in situ hybridization positive. All cycles were repeated every 14 days. On day 1, gemcitabine 1500 mg/m2 over 30 minutes was administered followed by carboplatin area under the curve of 2.5. Group 1 also received trastuzumab 8 mg/kg on day 1 of each cycle followed by 4 mg/kg for every 2 weeks thereafter. RESULTS: One hundred fifty patients were registered (50, 51, and 49 in groups 1, 2, and 3, respectively). The overall RRs were 64%, 27%, and 32%, respectively, with median time to progression of 7.2, 5.5, and 4.4 months, respectively. Overall, grade 3/4 toxicities included neutropenia (45%), leukopenia (17%), and thrombocytopenia (7%). Alopecia was infrequent: grade 1 (34%) and grade 2 (3%), and there was no significant cardiac toxicity. CONCLUSION: Gemcitabine/carboplatin/trastuzumab is highly active in patients with HER2-positive MBC. Gemcitabine/carboplatin is active in patients with HER2-negative MBC independent of previous taxane therapy. Gemcitabine/carboplatin with or without trastuzumab administered every 2 weeks is associated with a low frequency of serious toxicity.

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer.

PURPOSE: The taxanes and capecitabine have synergistic antitumor activity in preclinical models. This trial was designed to determine the efficacy and tolerability of weekly paclitaxel plus capecitabine as first-line treatment for metastatic breast cancer (MBC). PATIENTS AND METHODS: Participants had histologically proven breast cancer, with measurable metastatic disease by Response Evaluation Criteria in Solid Tumors Group. Exclusion criteria included prior taxane therapy or any prior capecitabine or infusional fluorouracil. Participants received capecitabine 825 mg/m2/dose orally bid (1,650 mg/m2/d) for days 1 to 14. Paclitaxel 80 mg/m2 was administered intravenously weekly on days 1 and 8. Cycles were repeated every 3 weeks. Responders (complete or partial) or those with stable disease were treated until progression of disease or intolerable toxicity. RESULTS: Fifty-five women were enrolled; 94% received study therapy as first-line treatment for MBC. In the intent-to-treat population, objective responses (partial) were achieved in 30 patients (55%; 95% CI, 40% to 69%), and six additional patients had stable disease for 6 months or longer (clinical benefit rate of 65%). The median duration of response was 10 months (range, 2.5 to 18.7 months). Dose modifications and reductions were common, particularly for capecitabine, leading to a delivered dose-intensity of 75% for capecitabine and 91% for paclitaxel. The most frequent grade 3 to 4 treatment-related adverse events were hand-foot skin reaction (n = 10); neutropenia (n = 7); fatigue (n = 4); and leukopenia, diarrhea, and pain (n = 3 each). CONCLUSION: Capecitabine in combination with weekly paclitaxel is an active and tolerable regimen as first-line therapy for women with MBC.