PubMed Health⌕ Search

Biomedical subjects

Carol M Moinpour

Publications and source records attributed to Carol M Moinpour.

14 recordsLinked to original sources
PubMed2006

Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone.

PURPOSE: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. METHODS: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. RESULTS: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. CONCLUSION: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.

Aged↗
PubMed2005

Erectile dysfunction and subsequent cardiovascular disease.

CONTEXT: The risk factors for cardiovascular disease and erectile dysfunction are similar. OBJECTIVE: To examine the association of erectile dysfunction and subsequent cardiovascular disease. DESIGN, SETTING, AND PARTICIPANTS: Men aged 55 years or older who were randomized to the placebo group (n = 9457) in the Prostate Cancer Prevention Trial at 221 US centers were evaluated every 3 months for cardiovascular disease and erectile dysfunction between 1994 and 2003. Proportional hazards regression models were used to evaluate the association of erectile dysfunction and cardiovascular disease. In an adjusted model, covariates included age, body mass index, blood pressure, serum lipids, diabetes, family history of myocardial infarction, race, smoking history, physical activity, and quality of life. MAIN OUTCOME MEASURES: Erectile dysfunction and cardiovascular disease. RESULTS: Of the 9457 men randomized to placebo, 8063 (85%) had no cardiovascular disease at study entry; of these men, 3816 (47%) had erectile dysfunction at study entry. Among the 4247 men without erectile dysfunction at study entry, 2420 men (57%) reported incident erectile dysfunction after 5 years. After adjustment, incident erectile dysfunction was associated with a hazard ratio of 1.25 (95% confidence interval [CI], 1.02-1.53; P = .04) for subsequent cardiovascular events during study follow-up. For men with either incident or prevalent erectile dysfunction, the hazard ratio was 1.45 (95% CI, 1.25-1.69; P<.001). For subsequent cardiovascular events, the unadjusted risk of an incident cardiovascular event was 0.015 per person-year among men without erectile dysfunction at study entry and was 0.024 per person-year for men with erectile dysfunction at study entry. This association was in the range of risk associated with current smoking or a family history of myocardial infarction. CONCLUSIONS: Erectile dysfunction is a harbinger of cardiovascular clinical events in some men. Erectile dysfunction should prompt investigation and intervention for cardiovascular risk factors.

Aged↗
PubMed2005

Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT).

Prostate cancer continues to be a major health threat, especially among African American men. The Selenium and Vitamin E Cancer Prevention Trial (SELECT), which opened on July 25, 2001, was planned to study possible agents for the prevention of prostate cancer in a population of 32,400 men in the United States, including Puerto Rico, and Canada. SELECT is a phase III randomized, placebo-controlled trial of selenium (200 microg/day from L-selenomethionine) and/or vitamin E (400 IU/day of all rac alpha-tocopheryl acetate) supplementation for a minimum of 7 years (maximum of 12 years) in non-African American men at least 55 years of age and African American men at least 50 years of age. SELECT is a large, simple trial that conforms as closely as possible with community standards of care. This commentary discusses the design problems the SELECT investigators had to resolve in developing the trial, including the role of prostate cancer screening, the best forms and doses of the study agents, and estimation of the event (prostate cancer) rate of men on the placebo arm.

Black or African American↗
PubMed2005

Data pooling and analysis to build a preliminary item bank: an example using bowel function in prostate cancer.

Assessing bowel function (BF) in prostate cancer can help determine therapeutic trade-offs. We determined the components of BF commonly assessed in prostate cancer studies as an initial step in creating an item bank for clinical and research application. We analyzed six archived data sets representing 4,246 men with prostate cancer. Thirty-one items from validated instruments were available for analysis. Items were classified into domains (diarrhea, rectal urgency, pain, bleeding, bother/distress, and other) then subjected to conventional psychometric and item response theory (IRT) analyses. Items fit the IRT model if the ratio between observed and expected item variance was between 0.60 and 1.40. Four of 31 items had inadequate fit in at least one analysis. Poorly fitting items included bleeding (2), rectal urgency (1), and bother/distress (1). A fifth item assessing hemorrhoids was poorly correlated with other items. Our analyses supported four related components of BF: diarrhea, rectal urgency, pain, and bother/distress.

Adult↗
PubMed2004

Phase II trial of vinorelbine for relapsed ovarian cancer: a Southwest Oncology Group study.

OBJECTIVES: To assess the activity of vinorelbine in women with recurrent or resistant epithelial ovarian cancer following treatment with platinum and paclitaxel in terms of survival rate at 6 months, objective response rate (in the subset of patients with bidimensionally measurable disease), and health-related quality of life. METHODS: Seventy-nine evaluable patients with progressive ovarian cancer following platinum and taxane therapy received vinorelbine 30 mg/m(2) days 1 and 8 of a 21-day treatment cycle. RESULTS: Six-month survival rate for the entire group was 65% (95% CI: 54-75%) and median survival was 10.1 months (95% CI: 7.7-13.6 months). In the 71 women with measurable disease, 0 complete and 2 partial responses were observed (RR = 3%) (95% CI: 0.3-10%). Patients reported substantial symptom-related distress at baseline, which persisted, but did not worsen, during treatment. Patients also had impaired physical functioning at baseline and this continued to decline during treatment. CONCLUSIONS: The 6-month survival rate achieved with salvage vinorelbine is comparable to the results obtained with other salvage therapies in patients with relapsed ovarian cancer. During the initial 10 weeks of treatment, vinorelbine did not appear to be effective in alleviating the symptom-related distress or progressive impairment of physical functioning associated with this disease.

Adult↗
PubMed2003

Social networks and quality of life among female long-term colorectal cancer survivors.

BACKGROUND: The population of long-term colorectal cancer survivors in the United States continues to increase, but little is known about how they fare-physically, mentally, or socially-in the years after diagnosis. The current study examines female long-term colorectal cancer survivors' health-related quality of life (HRQoL) in relation to social networks. METHODS: A population-based sample of female colorectal cancer survivors (n = 726) residing in Wisconsin was recontacted approximately 9 years after the initial diagnosis. Of 443 women who were alive in 1999, 307 women completed a follow-up questionnaire. Analysis was conducted on 259 participants who completed the Medical Outcomes Study Short Form 36 Health Status Survey and a modified version of Berkman and Syme's Social Network Index. Using multivariate analyses, HRQoL summary scores were tested for associations with individual and composite measures of social networks, including marital/partner status; number of children, relatives, and friends; and the frequency of religious and community participation. RESULTS: After adjusting for age, extent of disease at diagnosis, number of comorbidities, body mass, and education, HRQoL was similar to norms published for the general population. Individual social network measures (including the number of relatives and friends) and composite network measures (including network size, the number of ties seen at least once per month, and overall social connectedness) were associated positively with mental health. CONCLUSIONS: Social networks may have an important relation with HRQoL-particularly mental health-among female long-term colorectal cancer survivors. The results of this study should be of interest to those seeking to understand or improve HRQoL among this growing population.

Adult↗
PubMed2003

Health status and quality of life in patients with early-stage Hodgkin's disease treated on Southwest Oncology Group Study 9133.

PURPOSE: We describe the short and intermediate-term quality-of-life (QOL) outcomes in patients treated on a randomized clinical trial in early-stage Hodgkin's disease (Southwest Oncology Group [SWOG] 9133) comparing subtotal lymphoid irradiation (STLI) with combined-modality treatment (CMT). PATIENTS AND METHODS: Two hundred forty-seven patients participated in the QOL study (SWOG 9208), completing several standardized instruments (Symptom Distress Scale; Cancer Rehabilitation Evaluation System - Short Form; Medical Outcomes Study 36-Item Short-Form Health Survey Vitality Scale; and a health perception item), as well as questions about work, marital status, and concerns about having children. This article reports on results from baseline before random assignment, at 6 months, and at 1 and 2 years after random assignment. RESULTS: Patients receiving CMT experienced significantly greater symptom distress (P = .0001), [corrected] fatigue (P =.0001), [corrected] and poorer QOL (P =.015) at 6 months than the STLI patients, reflecting a shorter time since completion of therapy in the CMT arm. Importantly, patients in the two groups did not differ on any outcomes at the 1-and 2-year assessments. The study cohort at randomization exhibited more fatigue [corrected] than healthy reference populations. Fatigue levels did not exceed baseline estimates by the end of the study. [corrected]. CONCLUSION: This study demonstrated that patients with early-stage Hodgkin's disease experience a short-term decrease in QOL and an increase in symptoms and fatigue with treatment, which is more severe with CMT; by 1 year, however, CMT and STLI patients report similar outcomes. Fatigue scores for both arms were lower at baseline than scores for the general population and did not return to normal levels 2 years after random assignment. The mechanisms responsible for this lingering problem warrant further investigation.

Adolescent↗
PubMed2003

Correlations in perceived food use between the family food preparer and their spouses and children.

Previous research has demonstrated that family members' eating habits are similar. We hypothesized that family members' eating habits would be predicted by the eating habits of the person who prepares the majority of the family's meals and the number of meals the family shares. Participants were 282 members of religious organizations who identified themselves as family food preparers (FFPs), and provided information about their own and their family members' eating habits. Results revealed that FFP fruit and vegetable intake predicted the fruit and vegetable intake of spouses, children, and adolescents (p<0.01), and that FFP consumption of high-fat foods predicted the consumption of high-fat foods of spouses and children (p<0.01). Child fruit and vegetable consumption was also influenced by shared meals: the more meals the child shared with the FFP, the stronger the relationship of FFP fruit and vegetable intake with child fruit and vegetable intake (p<0.05). These findings indicate that dietary interventions targeting the FFP may benefit other family members.

Adult↗
PubMed2002

Economic analysis of vinorelbine plus cisplatin versus paclitaxel plus carboplatin for advanced non-small-cell lung cancer.

BACKGROUND: It is increasingly important to have timely information about the economic impact of new cancer therapies in today's cost-conscious environment. Nearly 170 000 people are diagnosed with lung cancer annually in the United States. We performed an economic analysis alongside Southwest Oncology Group Trial S9509 to estimate the cost-effectiveness of cisplatin plus vinorelbine versus carboplatin plus paclitaxel for patients with advanced non-small-cell lung cancer. There were no statistically significant differences in survival or cancer-related quality of life between the treatment arms. METHODS: Use of both protocol and nonprotocol lung cancer-related health care was tracked for 24 months from the initiation of therapy. To determine expenditures, nationally standardized costs were applied to each type of health care service used, and these were summed over time. Lifetime expenditures and 95% confidence intervals (CIs) for each arm of the trial were calculated with the use of a multivariate regression technique that accounts for censoring. Student's t tests were used to compare the difference in costs between the arms. All statistical tests were two-sided. RESULTS: Cancer-related health care costs over the period of observation averaged 40,292 dollars (95% CI = 36,226 dollars to 44,359 dollars) for patients in the cisplatin plus vinorelbine arm versus 48,940 dollars (95% CI = 44,674 dollars to 53,208 dollars) for patients in the carboplatin plus paclitaxel arm (P =.004), with a mean difference of 8648 dollars (95% CI = 2634 dollars to 14,662 dollars). Protocol chemotherapy drugs and medical procedures costs were statistically significantly higher in the paclitaxel arm (P =.0003 and P<.0001, respectively), whereas protocol chemotherapy delivery costs were statistically significantly higher in the vinorelbine arm (P<.0001). There was no difference between the arms in costs for blood products, supportive care medications, nonprotocol-related inpatient or outpatient care, and nonprotocol chemotherapy. CONCLUSIONS: Treatment with carboplatin plus paclitaxel is substantially and statistically significantly more expensive than treatment with cisplatin plus vinorelbine. The majority of the cost difference is due to the additional cost of the protocol chemotherapy (approximately 12,000 dollars). Notable differences in costs of downstream health care were not apparent.

Adult↗
PubMed2002

Individual differences in quality-of-life treatment response.

BACKGROUND: Individual differences in treatment responses to health-related quality-of-life interventions arise ubiquitously and prominently in clinical trials. These differences do not reflect error, but instead represent patterns of response that vary reliably across patients. Individual differences complement and qualify the information conveyed by average health-related quality-of-life effects for treatment arms. If clinicians and patients are to use health-related quality-of-life findings from clinical trials to make treatment decisions, they must have information about the extent and nature of such individual variation. The relatively small effect sizes of health-related quality-of-life outcomes in clinical trials offer a weak basis for generalizing results to new persons, and patients routinely anticipate likely treatment benefits for themselves that exceed these small effects. A focus on individual differences in treatment response can promote more realistic appreciation of expected benefit and uncertainty. A pharmacogenetic example shows how individual differences in drug metabolism can directly affect health-related quality-of-life treatment outcomes such as pain and physical functioning. MEASURES: The authors suggest how graphical displays can summarize individual responses and provide a context for interpreting the size and generality of the average treatment. Mixed-effects modeling subsumes average treatment differences and individual differences in a unified statistical analysis. Analysis of health-related quality-of-life data from an advanced colorectal cancer trial illustrates this approach. Objective statistical criteria indicate that, for this example, individual differences dominate the treatment difference. CONCLUSIONS: The authors suggest that presentation of the spectrum of individual responses and associated prediction intervals can convey clinically meaningful information regarding the impact of a treatment on health-related quality of life.

Antineoplastic Agents↗
PubMed2002

Assessing meaningful change in quality of life over time: a users' guide for clinicians.

The objective of this article is to help clinicians interpret trial-based quality of life (QOL) changes over time. We address a series of questions and provide guidelines that are fundamental to assessing and interpreting change. The issues addressed are as follows: (1) What are the characteristics of the population for whom changes in QOL are reported? (2) Is the QOL questionnaire reliable, valid, and responsive to change? (3) Are the timing and frequency of assessments adequate? (4) Is the study adequately powered? (5) How are multiple QOL outcomes addressed in analyses? (6) How are multiple time points handled? (7) Can alternative explanations account for the observed change or lack of observed change (eg, handling of missing data, survival differences, and changes in patient's QOL perspective over time)? and (8) How is statistical significance translated into meaningful change? These guidelines will support clinicians in reviewing the clinical trial literature, which in turn can help them use the data in the treatment decision process.

Adenocarcinoma↗
PubMed1992

Strengthened estimates of individual pain trends in children following bone marrow transplantation.

Pre-transplant conditioning regimens for bone marrow transplantation often cause oral mucositis and severe pain. We evaluated the agreement of self- and parent reports of daily oral mucositis pain in children between the ages of 6 and 16 years. Child patients were asked to report their pain on visual analog scales (VAS) daily for 20 days following their transplants. Daily VAS ratings were also obtained from one of the parents. The analysis sample consisted of ten children aged 7-9, nine children aged 10-12, eight children aged 13-16, and their parents. We modeled individual child and parent reports as quadratic functions of the number of days post transplant. Empirical Bayes/restricted maximum-likelihood estimates were obtained of individual coefficients, treated as random effects, and age group coefficients, treated as fixed effects. Parents exhibited higher average pain curves than their children in each of the three age groups. The middle age group reported the highest average pain. Average within-person error variances representing unreliability were 692.2, 461.9, and 303.9 for young, middle, and old children, respectively; for parents, the corresponding error variances were 375.1, 413.3, and 252.4. These results challenge the presumption that children tend to over-report pain but are consistent with the contention that younger children may be less reliable reporters than adolescents and adults.

Adolescent↗
PubMedDate not supplied

An educational program to increase cervical and breast cancer screening in Hispanic women: a Southwest Oncology Group study.

We conducted a community-based pilot study to train Hispanic cancer survivors as promotoras (lay health educators) to encourage their social contacts to obtain breast and cervical cancer screening. Promotoras were recruited from a private oncologist's practice at a Minority-Based Community Clinical Oncology Program (MBCCOP). Five Hispanic women were trained to serve as promotoras by attending a 12-week course. They shared cancer screening information with family and social contacts and encouraged them to obtain Papanicolaou smears and/or mammograms. Study endpoints included the number of women recruited and trained to serve as promotoras, the number of contacts made per promotora, and the number of contacts who were screened; data were based on contact logs maintained for 1 year. Screening examinations were documented by a postcard returned by the contact or by review of community health clinic records. Five promotoras contacted 141 (range = 24-49 per promotora) women to share cancer screening information. Fifty Hispanic women obtained screening after contact with a promotora. Twenty-nine underwent mammography (ages 25-58) and 43 received a Papanicolaou smear (ages 23-62). Hispanic female cancer survivors can be trained as promotoras. Screening information conveyed by a promotora can successfully prompt Hispanic women to obtain mammography and Papanicolaou smears.

Adult↗