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1.
J Nurs Adm ; 54(1): E5-E7, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-38117156

ABSTRACT

This project explored the relationship between virtual animal-related engagement (ARE) and anxiety in nurse leaders. A quality improvement project used a valid and reliable visual analog scale from 0 to 100 for self-reporting of anxiety in nurse leaders. Baseline and intervention group data were collected for 2 weeks at 15 and 5 minutes before the daily leadership huddle. Differences in anxiety levels 5 minutes before the huddle for baseline with the use of the intervention were significant. Within the intervention group, anxiety levels at 15 and 5 minutes were significant. Project outcomes suggest a difference in self-reported anxiety of nurse leaders based on ARE.


Subject(s)
Anxiety , Leadership , Animals , Humans , Anxiety/prevention & control , Pain Measurement , Quality Improvement , Self Report
2.
J Nurs Adm ; 52(7-8): 419-426, 2022.
Article in English | MEDLINE | ID: mdl-35857913

ABSTRACT

OBJECTIVE: The aim of this study was to examine the self-reported perceptions of the healthy work environment (HWE) of nurses who are members of Nursing Workplace Environment and Staffing Councils (NWESCs). BACKGROUND: In a statewide initiative, NWESCs were established at hospitals throughout the state of New Jersey as an alternative to nurse staffing ratio laws and to provide clinical nurses a voice in determining resources needed for patient care and support an HWE. METHODS: This quantitative descriptive study presents the results of the Healthy Workplace Environment Assessment Tool (HWEAT) and open-ended questions about NWESCs among a sample of 352 nurses. RESULTS: Three years after NWESC implementation, all HWEAT standard mean scores increased and were rated higher than the American Association of Critical-Care Nurses benchmark. There were statistically significant differences in clinical nurses' perceptions of an HWE compared with nurse leaders. Respondents also shared their NWESC's best practices and challenges. Responses to questions identified NWESC best practices and challenges. CONCLUSION: This study offers insight into the improvement in nurses' perceptions of the HWE after the introduction of a statewide NWESCs. Structures such as the NWESCs may provide an alternative to mandated staffing ratios.


Subject(s)
Nursing Staff, Hospital , Nursing Staff , Hospitals , Humans , New Jersey , Personnel Staffing and Scheduling , Workforce , Workplace
3.
Appl Nurs Res ; 65: 151573, 2022 06.
Article in English | MEDLINE | ID: mdl-35577480

ABSTRACT

AIM: The number of individuals in the United States (US) needing treatment for substance use disorder (SUD) but not receiving treatment at a specialty facility was reported to be almost 18 million in 2019. This study measured the difference in subsequent hospital visits between groups, one receiving screening, brief intervention, and referral to treatment (SBIRT) and one receiving usual care. BACKGROUND: There are studies that discuss SBIRT in terms of process evaluation, staff training, reduced readmission rates, and self-reported reductions in substance use. However, the interrelationship between components of SBIRT implementation, such as feasibility, cost, and sustainability need additional investigation. This study compared readmissions between groups receiving SBIRT counseling (n = 101) and those receiving usual care (n = 99). RESULTS: The overall total number of subsequent visits for SUD for the group receiving SBIRT (53) was significantly lower than for the group receiving usual care (128). The overall total number of non-SUD subsequent visits was not significantly different between groups. The study also identified differences between sexes that require further investigation. CONCLUSIONS: The findings of this study demonstrate a measure of difference based on SBIRT intervention. The SBIRT program can be incorporated into daily practice in the acute care setting through nursing education and utilization of the electronic health platform.


Subject(s)
Patient Readmission , Substance-Related Disorders , Humans , Inpatients , Mass Screening , Referral and Consultation , Substance-Related Disorders/diagnosis , Substance-Related Disorders/therapy , United States
4.
Appl Nurs Res ; 60: 151447, 2021 08.
Article in English | MEDLINE | ID: mdl-34247787

ABSTRACT

BACKGROUND: For older adults (≥65 years old), hospitalization can be a stressful and anxiety- provoking event. Due to physiological changes in this population that make pharmacological therapy to manage anxiety challenging, use of alternative therapies, such as animal-assisted activities (AAA), could prove beneficial. AIM: The purpose of this study was to determine if an AAA visit from a registered human-animal team during hospitalization would reduce perceived anxiety for older adults. DESIGN: A multicenter, interventional, comparative, pre-post design was used. METHODS: Eligible participants completed a demographic questionnaire and the Spielberger State-Trait Anxiety Inventory 6-item short form (STAI-6) survey prior to the AAA visit. AAA visits included interaction between the human-animal team and the participant at the bedside. At the conclusion of the visit, participants again completed the STAI-6. Demographic variables were analyzed using descriptive statistics and comparative analyses were performed using non-parametric tests to examine differences in pre-post STAI-6 scores. RESULTS: Participants (n = 141) had a median age of 75 years. The pre-visit median anxiety score was 14 (interquartile range [IQR] 10, 17), corresponding to mild baseline anxiety. The post-visit median anxiety score decreased significantly to 10 (IQR 7, 13) (p < 0.001). Weak associations were observed for gender (p = 0.025, r = 0.0189), and dog ownership (p = 0.026, r = 0.188). CONCLUSIONS: AAA significantly decreased anxiety in older adults with mild anxiety during inpatient hospitalization. This non-pharmacological intervention can be considered as an alternative intervention for anxiety in this population.


Subject(s)
Anxiety , Inpatients , Aged , Animals , Anxiety/therapy , Critical Care , Dogs , Humans , Surveys and Questionnaires
5.
J Nurs Manag ; 28(7): 1545-1552, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32681655

ABSTRACT

PURPOSE: To describe participants' perception of a formal statewide mentorship programme after changes had been made for programme improvement. METHODS: A qualitative descriptive design using focus group interviews was used to explore the experience of two cohorts of mentors and mentees, who participated in a structured, formalized nurse leader mentorship programme. DATA ANALYSIS: The investigators individually reviewed and analysed the transcripts and reached consensus on common themes using the constant comparison method of analysis. FINDINGS: Themes identified for the mentor focus group include the following: Giving Back; Rewarding and Energizing; Concrete Guidance; Not Always a Good Fit; Goal Setting; and Nourishing the Mentee. Mentee themes include the following: Lifeline for the Mentee; Moving from Reluctance to Reliance; Instilled Courage; and Gaining Confidence. A joint theme, Connected for Life, was also identified. CONCLUSION: The experience of mentors and mentees who participated in the statewide Mentorship Program was very positive as the participants stated that the program was effective in meeting its goals. Both mentees and mentors in this study found practical and emotional benefit through their participation in this formal Mentorship Program. IMPLICATIONS FOR NURSE MANAGEMENT: Statewide mentorship programmes can be effective mechanisms to support leaders or prospective leaders in their roles in an often chaotic and challenging health care environment.


Subject(s)
Mentoring , Mentors , Focus Groups , Humans , Perception , Program Evaluation , Prospective Studies , Qualitative Research
6.
Worldviews Evid Based Nurs ; 17(1): 60-70, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31621192

ABSTRACT

BACKGROUND: When staffing legislation was introduced, New Jersey nurse leaders recognized from the research and their years of clinical leadership experience that the work environment is a multidimensional concept and that staffing is not the only variable related to nurse and patient outcomes. Thus, an understanding of what nurses need in their hospital environment to practice nursing effectively was sought. AIMS: The aim of this study was to examine the evidence regarding clinical nurses' perception of what they need to practice nursing effectively in the acute care hospital environment. METHODS: The following population, intervention, comparison, outcome question was used to search the literature databases PubMed, CINAHL, Johanna Briggs, and the Sigma Theta Tau Henderson Library: In the hospital environment what do nurses perceive as needed to practice nursing effectively? Specific search criteria and the Johns Hopkins nursing guidelines and tools were used to identify relative studies. RESULTS: The final review, which addressed what nurses in the hospital environment need to practice nursing effectively, included 25 articles: 20 were an evidence level III, and five were evidence level II. From this review, five key concepts were identified: Leadership, autonomy/decision making, respect/teamwork, resources/staffing, and organizational commitment to nursing. LINKING EVIDENCE TO ACTION: This integrative review, which explored nurses' perceptions of what is needed to provide effective quality care, identified that providing quality care is multifactorial in nature. Resources, including but not limited to staffing, and leadership were identified as important by nurses as a key factor in supporting quality care. Nurses must be provided with resources and infrastructure to do their jobs, in an environment supported by authentic transformational leadership.


Subject(s)
Hospitals/trends , Leadership , Nurses/psychology , Workplace/standards , Humans , Job Satisfaction , Nurses/statistics & numerical data , Workload/psychology , Workload/standards , Workplace/psychology
7.
J Pediatr Nurs ; 46: 55-61, 2019.
Article in English | MEDLINE | ID: mdl-30852256

ABSTRACT

The purpose of this study was to evaluate the effect of a brief pet therapy visit and a comparison intervention on anxiety in hospitalized children. This quasi-experimental study compared state anxiety before and after structured research interventions in a convenience sample of children between the ages six and 17 (N = 93) in two groups. Participants were assigned to the pet therapy group or control group, based upon timing of data collection. Participants in each group received either a visit from the research assistant, therapy dog and handler, or from the research assistant for completion of a puzzle. The child's anxiety was measured using the State-Trait Anxiety Scale for Children (STAIC) S-Anxiety Scale before and after the visit and parents completed a brief background questionnaire. Intervention and comparison groups had no significant differences in key demographic factors or baseline anxiety level. While state anxiety decreased significantly in both groups, children in the pet therapy group experienced a significantly greater decrease in anxiety (p = .004). In addition, parents reported high levels of satisfaction with the pet therapy program. Study findings provide support for a brief pet therapy visit with a trained dog and handler as a tool decrease to anxiety in hospitalized children while promoting parent satisfaction. When resources for providing pet therapy visits are limited, clinicians may consider prioritizing children who are most affected by anxiety.


Subject(s)
Animal Assisted Therapy , Anxiety Disorders/prevention & control , Child, Hospitalized/psychology , Dogs , Adolescent , Animals , Child , Female , Hospitals, Pediatric , Humans , Male
8.
J Wound Ostomy Continence Nurs ; 46(4): 309-313, 2019.
Article in English | MEDLINE | ID: mdl-31274861

ABSTRACT

PURPOSE: The purpose of this study was to describe the effect of rigid or flexible stoma bridges used for loop ostomy diversions on peristomal skin integrity. Additional aims were to describe surgeon practices related to stoma bridges, and determine the availability of an ostomy nurse specialist. DESIGN: Retrospective chart review and cross-sectional survey. SAMPLE AND SETTING: The sample used to address the first aim (effect of stoma bridges) comprised 93 adult patients cared for at Morristown Medical Center, Atlantic Health System, Morristown, New Jersey, an acute care facility. Data provided by 355 colorectal surgeons from 30 countries were used to describe surgeon practice in this area and determine the availability of an ostomy nurse specialist. Respondents were invited from an international roster of colorectal surgeons obtained with permission from the American Society of Colon and Rectal Surgeons (ASCRS). METHODS: In order to accomplish the initial aim, we retrospectively reviewed medical records of patients who underwent ostomy surgery from 2008 to 2015 and met inclusion criteria. In order to meet our additional aims, analyzed data were obtained from a survey of colorectal surgeons that queried practices related to stoma bridges, and availability of an ostomy nurse specialist. RESULTS: Patients managed with a rigid bridge were significantly more likely to experience leakage beneath the pouching system faceplate than were patients managed by a flexible bridge (42% vs 11%, P < .001). Slightly less than one quarter of patients who developed leakage (n = 22, 24%) experienced pressure and moisture-related peristomal skin complications. Peristomal wounds, inflammation, and infection were significantly higher when a rigid bridge was used (χ test, P < .003). The surgeon's survey (N = 355) showed variability in the use of bridges. Ninety-three percent of all surgeons indicated an ostomy nurse specialist was part of their health care team. CONCLUSIONS: Rigid ostomy bridges were associated with a higher likelihood of leakage from underneath the faceplate of the pouching system and impaired peristomal skin integrity. Analysis of colorectal surgeon responses to a survey indicated no clear consensus related to bridge use in patients undergoing loop ostomies.


Subject(s)
Digestive System Surgical Procedures/methods , Outcome Assessment, Health Care/standards , Surgical Stomas/classification , Adult , Aged , Cross-Sectional Studies , Digestive System Surgical Procedures/standards , Digestive System Surgical Procedures/trends , Female , Global Health/trends , Humans , Male , Middle Aged , Outcome Assessment, Health Care/trends , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Retrospective Studies , Statistics, Nonparametric , Surgical Stomas/trends
9.
Worldviews Evid Based Nurs ; 14(5): 394-402, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28395396

ABSTRACT

BACKGROUND: Aromatherapy has been used to reduce anxiety in a variety of settings, but usefulness associated with breast biopsies has not been documented. AIMS: This study was conducted in women undergoing image-guided breast biopsy. We explored the use of two different aromatherapy scents, compared to placebo, aimed at reducing anxiety with the intent of generating new knowledge. METHODS: This was a randomized, placebo-controlled study of two different types of external aromatherapy tabs (lavender-sandalwood and orange-peppermint) compared with a matched placebo-control delivery system. Anxiety was self-reported before and after undergoing a breast biopsy using the Spielberger State Anxiety Inventory Scale. RESULTS AND FINDINGS: Eighty-seven women participated in this study. There was a statistically significant reduction in self-reported anxiety with the use of the lavender-sandalwood aromatherapy tab compared with the placebo group (p = .032). Aromatherapy tabs reduced anxiety during image-guided breast biopsy. LINKING EVIDENCE TO ACTION: The completion of the biopsy provided some relief from anxiety in all groups. The use of aromatherapy tabs offers an evidence-based nursing intervention to improve adaptation and reduce anxiety for women undergoing breast biopsy. Lavender-sandalwood aromatherapy reduced anxiety and promoted adaptation more than orange-peppermint aromatherapy or placebo.


Subject(s)
Anxiety/psychology , Aromatherapy/standards , Biopsy/psychology , Adult , Aromatherapy/methods , Biopsy/methods , Breast/pathology , Factor Analysis, Statistical , Female , Humans , Middle Aged , Psychometrics/instrumentation , Psychometrics/methods , Statistics, Nonparametric
11.
J Contin Educ Nurs ; 54(8): 360-366, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37531653

ABSTRACT

Evidence-based practice (EBP) skill building among clinical nurses is a priority for nurses in professional development because it is well known that this approach to clinical decision-making results in safe, cost-effective, person-centered care. Recent studies indicate widespread lack of self-reported competency in EBP skills among nurses, demonstrating the importance of prioritizing programs that meet clinical nurses' needs for EBP education. The goal of this design thinking project was to expand and diversify an EBP skill building program to provide more widespread accessibility across a multi-hospital health care system. The team followed the five-step human-centered design thinking process to empathize, define, ideate, prototype, and test an innovation. Based on end user feedback, a dual-track EBP educational program, with options for an intensive yearlong hybrid EBP Scholars program and a three-session skill building webinar series, was implemented. Design thinking provides a rich framework for incorporating end user feedback to generate innovations to address challenges in health care. [J Contin Educ Nurs. 2023;54(8):360-366.].


Subject(s)
Delivery of Health Care , Evidence-Based Practice , Humans , Education, Nursing, Continuing , Educational Status , Clinical Competence , Surveys and Questionnaires , Evidence-Based Nursing/education
12.
Appl Nurs Res ; 25(1): 3-16, 2012 Feb.
Article in English | MEDLINE | ID: mdl-20974079

ABSTRACT

BACKGROUND: Throughout the illness trajectory, women with breast cancer experience issues that are related to physical, emotional, and social adjustment. Despite a general consensus that state-of-the-art treatment for breast cancer should include educational and counseling interventions to reduce illness or treatment-related symptoms, there are few prospective, theoretically based, phase-specific randomized, controlled trials that have evaluated the effectiveness of such interventions in promoting adjustment. PURPOSE: The aim of this study is to examine the physical, emotional, and social adjustment of women with early-stage breast cancer who received psychoeducation by videotapes, telephone counseling, or psychoeducation plus telephone counseling as interventions that address the specific needs of women during the diagnostic, postsurgery, adjuvant therapy, and ongoing recovery phases of breast cancer. DESIGN: Primary data from a randomized controlled clinical trial. SETTING: Three major medical centers and one community hospital in New York City. METHODS: A total of 249 patients were randomly assigned to either the control group receiving usual care or to one of the three intervention groups. The interventions were administered at the diagnostic, postsurgery, adjuvant therapy, and ongoing recovery phases. Analyses were based on a mixed model analysis of variance. MAIN RESEARCH VARIABLES AND MEASUREMENT: Physical adjustment was measured by the side effects incidence and severity subscales of the Breast Cancer Treatment Response Inventory (BCTRI) and the overall health status score of the Self-Rated Health Subscale of the Multilevel Assessment Instrument. Emotional adjustment was measured using the psychological well-being subscale of the Profile of Adaptation to Life Clinical Scale and the side effect distress subscale of BCTRI. Social adjustment was measured by the domestic, vocational, and social environments subscales of the Psychosocial Adjustment to Illness Scale. FINDINGS: Patients in all groups showed improvement over time in overall health, psychological well-being, and social adjustment. There were no significant group differences in physical adjustment, as measured by side effect incidence, severity, or overall health. There was poorer emotional adjustment over time in the usual care (control) group as compared to the intervention groups on the measure of side effect distress. For the telephone counseling group, there was a marked decline in psychological well-being from the adjuvant therapy phase through the ongoing recovery phase. There were no significant group differences in the dimensions of social adjustment. CONCLUSION: The longitudinal design of this study has captured the dynamic process of adjustment to breast cancer, which in some aspects and at various phases has been different for the control and intervention groups. Although patients who received the study interventions improved in adjustment, the overall conclusion regarding physical, emotional, and social adjustment is that usual care, which was the standard of care for women in both the usual care (control) and intervention groups, supported their adjustment to breast cancer, with or without additional interventions. IMPLICATIONS FOR NURSING: The results are important to evidence-based practice and the determination of the efficacy and cost-effectiveness of interventions in improving patient outcomes. There is a need to further examine adjustment issues that continue during the ongoing recovery phase. KEY POINTS: Psychoeducation by videotapes and telephone counseling decreased side effect distress and side effect severity and increased psychological well-being during the adjuvant therapy phase. All patients in the control and intervention groups improved in adjustment. Adjustment issues are still present in the ongoing recovery phase.


Subject(s)
Adaptation, Psychological , Breast Neoplasms/psychology , Counseling , Social Adjustment , Telemedicine , Videotape Recording , Analysis of Variance , Breast Neoplasms/therapy , Case-Control Studies , Combined Modality Therapy , Female , Humans , Longitudinal Studies , Middle Aged , New York City , Prospective Studies
13.
J Holist Nurs ; 39(1): 4-15, 2021 Mar.
Article in English | MEDLINE | ID: mdl-32649851

ABSTRACT

Purpose: The purpose of this research was to explore the impact of Jin Shin Jyutsu (JSJ) Self-Help on personal stress and the caring efficacy of nurses. Design: A randomized, controlled comparison study, with crossover design was conducted. Method: Stress and caring efficacy were measured via surveys at baseline, posteducation, and again 30 to 40 days after completion of the JSJ educational intervention. Self-reported stress was the primary endpoint as measured with the validated Personal and Organizational Quality Assessment-Revised 4 Scale (POQA-R4) survey. Caring Efficacy was measured using the Coates Caring Efficacy Scale. Findings: A total of 41 nurses consented and completed the study; 18 were in the education group and 23 were in the control group. Changes in stress were sustained in the education group for the POQA-R4. Changes observed in the control group were not sustained. Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy. Increases in nursing caring efficacy were observed in both groups. Scores were consistently higher in the education group. Statistically significant differences were observed from baseline to final measure for the education group. Conclusions: Results show JSJ as a viable option for stress reduction in nurses.


Subject(s)
Nursing Care , Health Behavior , Humans , Surveys and Questionnaires
14.
J Nurses Prof Dev ; 35(6): 317-323, 2019.
Article in English | MEDLINE | ID: mdl-31652171

ABSTRACT

Seventeen senior bachelor of science in nursing students participated in a dedication education unit. The longitudinal study findings were statistically significant (p < .05) in all areas of measure: Health Education System Inc, critical thinking scores, decreased anxiety, self-efficacy, self-confidence in clinical decision-making, and confidence. Findings from this study were translated into the clinical institution's onboarding process, the Practice Transition Program, which was restructured and accredited by the American Nurses Credentialing Center in 2019.


Subject(s)
Anxiety/psychology , Clinical Competence/standards , Students, Nursing/statistics & numerical data , Thinking , Adult , Curriculum , Decision Making , Education, Nursing, Baccalaureate , Educational Measurement , Female , Humans , Longitudinal Studies , Male , Nursing Education Research , Young Adult
15.
Nurs Res ; 57(3): 199-213, 2008.
Article in English | MEDLINE | ID: mdl-18496106

ABSTRACT

BACKGROUND: Although various forms of psychoeducation and counseling interventions have been examined among patients with a variety of diagnoses, the unique contribution of phase-specific psychoeducation and telephone counseling (TC) to the ongoing process of adjustment has not been explored among patients with breast cancer and their partners. OBJECTIVE: To conduct a randomized controlled clinical trial of phase-specific evidence-based psychoeducation and TC interventions to enhance emotional, physical, and social adjustments in patients with breast cancer and their partners. METHODS: A purposive sample of 249 patient-partner dyads were assigned randomly to one of four groups: (a) control group receiving disease management (DM), (b) standardized psychoeducation (SE), (c) TC, or (d) standardized psychoeducation plus telephone counseling (SE + TC). Data were collected at baseline, diagnostic, postsurgery, adjuvant therapy, and ongoing recovery phases measuring emotional, physical, and social adjustments. RESULTS: Patients showed poorer adjustment over time in the DM group relative to those receiving interventions on selected measures of emotional adjustment. All patients showed improvement over time in overall health and adjustment in social and vocational environments. Partners in all groups exhibited improvement over time for measures of adjustment in the social environment but no changes in psychological well-being or overall health. Partners in the TC group had poorer scores on physical symptoms compared with the SE + TC group and poorer vocational scores compared with the DM group. DISCUSSION: Findings from this study provide preliminary support for the value of phase-specific SE and TC interventions to enhance selected adjustment outcomes for patients with breast cancer and their partners.


Subject(s)
Adaptation, Psychological , Breast Neoplasms/psychology , Counseling , Health Education/methods , Social Adjustment , Adult , Aged , Aged, 80 and over , Breast Neoplasms/classification , Breast Neoplasms/therapy , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Psychometrics
16.
J Contin Educ Nurs ; 48(12): 552-556, 2017 Dec 01.
Article in English | MEDLINE | ID: mdl-29177528

ABSTRACT

This article describes an academic-practice partnership between an American Nurses Credentialing Center Magnet®-designated hospital and an academic nurse educator that has increased the hospital's capacity for research, evidence-based practice, and support for nurses continuing their education. Through close collaboration with the full-time nurse researcher and members of the nursing education department, the professor in residence consults with clinical staff to support completion of research and evidence-based practice projects. The collaboration also has resulted in the development of a formal year-long mentoring program for clinical nurses in the area of evidence-based practice. Individual support and academic consults are offered to nurses enrolled in school to promote advancement of nurses' educational level. This collaboration has been beneficial for both the hospital and the university, increasing the capacity for scholarly activities for nurses in the hospital and serving as a forum for ongoing faculty practice and scholarship. J Contin Educ Nurs. 2017;48(12):552-556.


Subject(s)
Education, Nursing, Continuing/organization & administration , Faculty, Nursing/organization & administration , Hospitals, Teaching/organization & administration , Interinstitutional Relations , Nursing Research/education , Nursing Staff, Hospital/education , Research Support as Topic , Adult , Female , Humans , Male , Middle Aged
17.
Nurs Manage ; 48(6): 24-30, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28486383

ABSTRACT

Transformational leaders at one medical center acted fast when lead was found in the water supply.


Subject(s)
Academic Medical Centers/organization & administration , Lead/analysis , Leadership , Nurse Administrators/organization & administration , Water Supply , Humans , New Jersey
18.
J Clin Oncol ; 21(23): 4277-84, 2003 Dec 01.
Article in English | MEDLINE | ID: mdl-14581438

ABSTRACT

PURPOSE: Bone metastases occur in approximately 80% of patients with advanced prostate cancer. Pain is common in these patients. The purpose of this study was to evaluate the effect of an intravenous bisphosphonate, pamidronate disodium, on pain control in metastatic prostate cancer patients. PATIENTS AND METHODS: Two multicenter, double-blind, randomized, placebo-controlled trials were conducted in patients with bone pain due to metastatic prostate cancer, with disease progression after first-line hormonal therapy. Intravenous pamidronate disodium (90 mg) or placebo was administered every 3 weeks for 27 weeks. Efficacy was measured via self-reported pain score (Brief Pain Inventory), analgesic use, the proportion of patients with a skeletal-related event (SRE; defined as pathologic fracture, radiation or surgery to bone, spinal cord compression, or hypercalcemia), and a pilot quantitative measurement of mobility. Laboratory evaluations included serum prostate-specific antigen, interleukin-6, bone alkaline phosphatase, and urinary bone resorption markers. RESULTS: Results of the two trials were pooled. There were no sustained significant differences between the pamidronate and placebo groups in self-reported pain measurements, analgesic use, proportion of patients with an SRE, or mobility at week 9 or 27. Urinary bone resorption markers were suppressed in the pamidronate group compared with placebo. CONCLUSION: Pamidronate disodium failed to demonstrate a significant overall treatment benefit compared with placebo in palliation of bone pain or reduction of SREs. Evaluation of more potent bisphosphonates in patients with prostate cancer is warranted.


Subject(s)
Antineoplastic Agents/therapeutic use , Bone Neoplasms/drug therapy , Diphosphonates/therapeutic use , Pain/drug therapy , Prostatic Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Bone Neoplasms/secondary , Diphosphonates/adverse effects , Double-Blind Method , Humans , Male , Middle Aged , Palliative Care , Pamidronate , Placebos , Prostatic Neoplasms/pathology , Retrospective Studies , Treatment Outcome
19.
Clin Cancer Res ; 9(16 Pt 1): 5880-7, 2003 Dec 01.
Article in English | MEDLINE | ID: mdl-14676110

ABSTRACT

PURPOSE: The purpose of our study was to assess the objective response to imatinib administered to patients with small cell lung cancer (SCLC). EXPERIMENTAL DESIGN: Eligible patients were those with SCLC who either had chemotherapy-naive extensive-stage or had SCLC in a sensitive relapse. Patients enrolled on the trial were treated with 600 mg of imatinib daily. The response was assessed using Southwest Oncology Group (SWOG) criteria after 3 and 6 weeks. Tumor specimens were examined by immunohistochemistry for the KIT receptor. RESULTS: Nineteen patients with SCLC entered on the study, including 16 men and 3 women. Nine patients had previously untreated extensive-stage disease and 10 patients had sensitive relapse. A central pathology review confirmed SCLC in only 14 of the 19 patients. There were no objective responses; however, one patient with sensitive-relapse disease had prolonged stabilization of disease (>3 months) while on imatinib therapy. The median time to progression was 0.8 months (range, 0.6-1.3 months) and 1.2 months (range, 0.2-4.1 months) in the previously untreated and sensitive-relapse groups, respectively. Tumor tissue samples from 4 (21%) of the 19 patients had the KIT receptor (CD117). CONCLUSIONS: There was no observed antitumor activity in this limited Phase II trial of patients with SCLC, of which only a few tumors showed expression of the imatinib target. The results of this trial are, thus, inconclusive about the antitumor activity of imatinib against SCLC with the targeted KIT receptor (CD117). Further testing of imatinib in patients with SCLC will focus on demonstration of KIT expression in the setting of confirmed SCLC histology.


Subject(s)
Antineoplastic Agents/therapeutic use , Carcinoma, Small Cell/drug therapy , Lung Neoplasms/drug therapy , Piperazines/therapeutic use , Proto-Oncogene Proteins c-kit/drug effects , Pyrimidines/therapeutic use , Adult , Aged , Benzamides , Carcinoma, Small Cell/metabolism , Carcinoma, Small Cell/pathology , Disease Progression , Female , Humans , Imatinib Mesylate , Immunoenzyme Techniques , Lung Neoplasms/metabolism , Lung Neoplasms/pathology , Male , Middle Aged , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/pathology , Proto-Oncogene Proteins c-kit/metabolism , Treatment Outcome
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