Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking among cervical cancer survivors is strikingly high, yet no smoking cessation interventions to date have specifically targeted this population. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial designed to evaluate the efficacy of a theoretically and empirically based Motivation And Problem Solving (MAPS) approach for promoting and facilitating smoking cessation among cervical cancer survivors. MAPS is a comprehensive, dynamic, and holistic intervention that incorporates empirically supported cognitive behavioral and social cognitive theory-based treatment strategies within an overarching motivational framework. MAPS is designed to be appropriate for all smokers regardless of their motivation to change and views motivation as dynamically fluctuating from moment to moment throughout the behavior change process. OBJECTIVE: This 2-group randomized controlled trial compares the efficacy of standard treatment to MAPS in facilitating smoking cessation among women with a history of high-grade cervical dysplasia or cervical cancer. METHODS: Participants (N=202) are current smokers with a history of high-grade cervical dysplasia or cervical cancer recruited nationally and randomly assigned to one of two treatment conditions: (1) standard treatment (ST) or (2) MAPS. ST consists of repeated letters referring participants to their state's tobacco cessation quitline, standard self-help materials, and free nicotine replacement therapy when ready to quit. MAPS has all ST components along with 6 proactive telephone counseling sessions delivered over 12 months. The primary outcome is abstinence from tobacco at 18 months. Secondary outcomes include abstinence over time across all assessment points, abstinence at other individual assessment time points, quit attempts, cigarettes per day, and use of state quitlines. Hypothesized treatment mechanisms and cost-effectiveness will also be evaluated. RESULTS: This study was approved by the institutional review boards at the University of Texas MD Anderson Cancer Center, the University of Oklahoma Health Sciences Center, and Moffitt Cancer Center. Participant enrollment concluded at Moffitt Cancer Center in January 2020, and follow-up data collection was completed in July 2021. Data analysis is ongoing. CONCLUSIONS: This study will yield crucial information regarding the efficacy and cost-effectiveness of a MAPS approach for smoking cessation tailored to the specific needs of women with a history of high-grade cervical dysplasia or cervical cancer. Findings indicating that MAPS has substantially greater efficacy than existing evidence-based tobacco cessation treatments would have tremendous public health significance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02157610; https://clinicaltrials.gov/ct2/show/NCT02157610. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34502.

Risk and outcomes of chemotherapy-induced diarrhea (CID) among patients with colorectal cancer receiving multi-cycle chemotherapy.

BACKGROUND: Diarrhea is a common toxicity of chemotherapy, but the practice of reporting only severe grades (≥ 3) in clinical trials results in misleading conclusions of significance. Epidemiology remains poorly described, and effects of multi-cycle regimens have not been investigated. To better understand the risks, symptom burden and consequences of CID, we studied patients receiving chemotherapy for colorectal cancer (CRC). METHODS: One hundred and fourteen patients receiving FOLFOX (95 patients, 530 cycles), FOLFOX + monoclonal antibodies (10 patients, 49 cycles) or FOLFIRI (9 patients, 50 cycles) were enrolled. CID was identified from diaries at baseline and daily during up to 8 chemotherapy cycles using supplemental questions on the Oral Mucositis Daily Questionnaire, a valid tool for collecting patient-reported outcomes of regimen-related mucosal injury. Patients scored CID severity from 0 "none" to 10 "worst possible," and quantity from "little" to "severe" on a 5-point scale. Quality of life was measured using the FACT-G, and fatigue using the FACIT fatigue scale. RESULTS: CID occurred in 89% of patients on FOLFIRI, 50% on FOLFOX + monoclonal antibodies and 56% on FOLFOX alone. The risk of a first episode was highest during Cycle 1 (35 %) and dropped to <10% during Cycles 3-5. Patients with CID reported poorer quality of life scores than those without CID (77.1 vs 80.7). CONCLUSIONS: Diarrhea occurs more commonly than typically appreciated during chemotherapy for CRC. Risk is highest during first exposure, suggesting variable susceptibility. Identification of this high-risk subgroup for prophylaxis could improve the quality of life.

Adherence to national guidelines for antiemesis prophylaxis in patients undergoing chemotherapy for lung cancer: a population-based study.

BACKGROUND: Nausea and vomiting (N/V) during chemotherapy can have profound clinical and economic consequences. Effective antiemetic agents are available for prophylaxis, but barriers may prevent their use. For this population-based study, the authors assessed the rates of antiemetic prophylaxis use, and predictors of such use, among patients who were receiving platinum-based chemotherapy for lung cancer between 2001 and 2007. METHODS: The authors searched the Texas Cancer Registry-Medicare-linked database for individuals aged >65 years who received platinum-based chemotherapy within 12 months after a first diagnosis of lung cancer from 2001 to 2007; and all patients had continuous Medicare Part A and Part B coverage for the same period. Adherence to recommended regimens for N/V prophylaxis (established by the National Comprehensive Cancer Network) was scored as a binary variable (adherent vs nonadherent) and was calculated as the percentages of treated patients receiving each recommended agent within 1 day of beginning chemotherapy. Logistic regression with stepwise selection was used to examine whether patient characteristics influenced adherence. RESULTS: Of 4566 selected patients, adherence rates for the receipt of serotonin antagonists (eg, ondansetron) with dexamethasone were 60% to 90% regardless of whether the chemotherapy agent was considered moderately or highly emetogenic. The receipt of substance-P antagonists was much less common (<10%) during any period. On multivariate logistic regression modeling, variables that predicted adherence were older age, white race, higher median income, and concurrent radiation therapy. CONCLUSIONS: Recommended use of antiemetics for prophylaxis, especially substance-P antagonists, during chemotherapy for lung cancer is suboptimal. Factors that were correlated with adherence suggest socioeconomic barriers in the community.

Clinical model of lifetime cost of treating bladder cancer and associated complications.

OBJECTIVES: To estimate the lifetime cost of bladder cancer and the contribution of complications to the total costs. METHODS: We reviewed the medical records of a retrospective cohort of 208 patients with bladder cancer who registered at our comprehensive cancer center from 1991 to 1999. We multiplied the number of resources used during management of bladder cancer by their unit charges. We converted charges into costs using the Medicare cost-to-charge ratio and inflated these to 2005 U.S. dollars. We estimated future costs by creating two extreme hypothetical scenarios. In the best-case scenario, we assumed patients with superficial disease developed recurrences at the cohort's mean rate and that patients with muscle-invasive disease were disease free after definitive therapy. Survival was based on the U.S. life expectancy in both cases. In the worst-case scenario, we assumed patients with superficial disease developed muscle-invasive disease and that all patients subsequently died of bladder cancer. RESULTS: The average cost of bladder cancer was 65,158 dollars among the cohort patients. Sixty percent of this cost (39,393 dollars) was associated with surveillance and treatment of recurrences, and 30% (19,811 dollars) was attributable to complications. The lifetime cost of bladder cancer was lower for the worst-case scenario (99,270 dollars) than for the best-case scenario (120,684 dollars). However, a greater proportion of the costs were attributable to complications with the worst-case scenario (43%, 42,290 dollars) compared with the best (28%, 34,169 dollars). CONCLUSIONS: The management of bladder cancer and its associated complications results in a major economic burden. More cost-effective surveillance strategies and approaches for preventing complications are crucial to minimizing the disease's clinical and economic consequences.

Cost-minimization analysis of low-molecular-weight heparin (dalteparin) compared to unfractionated heparin for inpatient treatment of cancer patients with deep venous thrombosis.

GOALS: Low-molecular-weight heparin (LMWH) has shown to be as effective as unfractionated heparin (UFH) in the treatment of deep venous thrombosis (DVT). Although the acquisition cost of LMWH is significantly greater than that of UFH, we hypothesized that once-daily dalteparin, a LMWH, could reduce treatment costs of cancer patients with DVT by eliminating anticoagulation monitoring and shortening hospitalization. PATIENTS AND METHODS: We developed a cost-minimization model by using outcomes and resource utilization data from two retrospective matched cohorts of cancer patients who, between 1994 and 1999, were hospitalized at our comprehensive cancer center for treatment of DVT with either LMWH ( n=21) or UFH ( n=168). We assumed all LMWHs and UFH to be equally effective. The total costs for the dalteparin strategy and the UFH strategy were calculated in year 2003 U.S. dollars, from the provider's perspective, by multiplying the number of resources used for inpatient treatment of DVT by their unit costs. RESULTS: The mean total cost for inpatient care was $3,383 US dollars (95% CI= $2,683- $4,083) for dalteparin and $4,952 US dollars (95% CI=$4,718-$5,185) for UFH. Substantial savings resulted from shorter hospitalization among the dalteparin-treated patients (mean 3.19 versus 5.22 days). Sensitivity analysis did not change the conclusion that dalteparin is less expensive than UFH. CONCLUSIONS: Savings realized from less anticoagulant monitoring and shorter hospitalization offset the higher acquisition cost of dalteparin. The dalteparin strategy is less expensive than the UFH strategy for the inpatient treatment of DVT among cancer patients.