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Developing a web-based portal to improve chemotherapy dose selection: A pilot study. T. May Pini, MD, MPH Division of Hematology/Oncology September 16, 2010. Breast Cancer. 2010 in the U.S. ~200,000 new cases of breast cancer ~40,000 deaths. Adjuvant Chemotherapy.
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Developing a web-based portal to improve chemotherapy dose selection: A pilot study T. May Pini, MD, MPH Division of Hematology/Oncology September 16, 2010
Breast Cancer • 2010 in the U.S. • ~200,000 new cases of breast cancer • ~40,000 deaths
Adjuvant Chemotherapy • Treatment given after surgery to increase the chances of cure • Regimens include 2 or more chemotherapy agents • Typically given for 4 to 8 “cycles” • 1st cycle dose based on clinical trials • Responsive dose reductions, due to therapy-related toxicities, may be required for subsequent cycles
Chemotherapy Dose • Body surface area (BSA) calculated using weight & height • Chemotherapy doses calculated using BSA & standard chemotherapy protocols • Example: “AC” x 4 cycles • Doxorubicin dose (mg) = 60 mg/m2 x BSA • Cyclophosphamide dose (mg) = 600 mg/m2 x BSA Full dose calculated by using actual body weight Slide modified from slide courtesy of Dr. Griggs
Background: The dose problem • Full doses of adjuvant chemotherapy needed to achieve optimal disease-free survival (DFS) & overall survival (OS)
Background: The dose problem • No evidence toxicity greater in obese patients • Side effects less common among obese patients, even when fully dosed • ~ 40% of overweight & obese breast cancer patients receive reduced doses
Background: Role of the medical oncologist Decisions about giving/receiving adjuvant chemotherapy shared between oncologist & patient Dose selection solely decided upon by medical oncologist
Practice Variation in the Use of First Cycle Dose Reduction among Overweight and Obese Patients, n = 919 Ann Intern Med 2005, slide courtesy of Dr. Griggs
Potential influences on 1st cycle dose selection • Practice Characteristics • Size of practice • Competing demands • Availability of practice guidelines • Availability of standardized chemotherapy orders • Daily volume of encounters • Opportunity costs (workload from treatment toxicities) • On-call frequency • Availability of fellows, NP’s, PA’s • Pharmacy policies and pharmacist knowledge/behavior • Nursing knowledge/behavior First cycle DOSE SELECTION • Physician Characteristics • Years in practice • Oncology board certification • Extent of subspecialization • INTERNAL FACTORS • Knowledge, attitudes, beliefs • Perceived Risk:Benefit ratio of treatment with full weight based dosing
Potential influences on 1st cycle dose selection • Practice Characteristics • Size of practice • Competing demands • Availability of practice guidelines • Availability of standardized chemotherapy orders • Daily volume of encounters • Opportunity costs (workload from treatment toxicities) • On-call frequency • Availability of fellows, NP’s, PA’s • Pharmacy policies and pharmacist knowledge/behavior • Nursing knowledge/behavior First cycle DOSE SELECTION • Physician Characteristics • Years in practice • Oncology board certification • Extent of subspecialization • INTERNAL FACTORS • Knowledge, attitudes, beliefs • Perceived Risk:Benefit ratio of treatment with full weight based dosing
Potential influences on 1st cycle dose selection • INTERNAL FACTORS • Knowledge, attitudes, beliefs • Perceived Risk:Benefit ratio of treatment with full weight based dosing • External factors modifying perceived Risk:Benefit ratio • Professional society practice guidelines • CME • Peer-reviewed literature • Beliefs of opinion leaders about dose selection • Beliefs of colleagues about dose selection • Prior experience with treatment toxicities • Patient characteristics modifying perceived Risk:Benefit ratio • BMI • Comorbidities • Age • Sex • Degree of social support • Patient concerns regarding dose selection
Potential influences on 1st cycle dose selection • Not much known about oncologist knowledge, attitudes, & beliefs regarding use of full weight-based chemotherapy dosing in curative intent settings • Not much known about effects of individual oncologist & practice characteristics on use of full weight-based chemotherapy doses
Background: Audit and feedback • Definition (Cochrane 2009) • Summary of clinical performance of health care • May include recommendations for clinical action • Used to improve practice behaviors • Effectiveness improved when feedback delivered with specific suggestions for improvement (Hysong 2009) • May be effective in improving medical oncologist dose selection practice
Background: Using the web • Interactive web-based technology ideal platform to reach medical oncologists • Advantages • Target wide range of practice settings • Cost-effective • Modifiable
Specific Aims • Develop web-based system to (1) survey medical oncologists about dose selection practices, (2) provide tailored feedback regarding optimal dosing of adjuvant chemotherapy for obese women with breast cancer • Assess effectiveness of tailored feedback intervention on improvement in use of full weight dosing of adjuvant chemotherapy for obese breast cancer patients • Investigate physician and practice characteristics associated with reduced versus full weight dosing in treatment of cancer in curative intent settings
Medical oncologists & hematologists (N = 200) • Recruited from practices participating in the Michigan Breast Oncology Quality Initiative (MiBOQI) • Excluding: • Bone marrow transplant • Only non-malignant hematologic conditions Subjects & Recruitment: Baseline Day 1: Invitation to participate via letter from MiBOQI Director Week 2: Non-participants contacted by phone and faxed duplicate letter if requested Weeks 3-4: Non-responders emailed up to 2 times with request to complete survey
Subjects & Recruitment: Follow-up Physicians who see breast cancer patients 3 mo. after completion of baseline survey: Email to complete a brief follow-up survey Follow-up weeks 1-2: Non-responders will be contacted up to 2 additional times via email requesting completion of the follow-up survey
Tailored Feedback Intervention • Medical oncologists who see breast cancer patients will be asked how they dose obese patients when treating breast cancer in the adjuvant setting • Full doses are calculated using actual body weight • What is the most appropriate way to dose obese breast cancer patients? Please check ONE. • Actual body weight • Ideal body weight • Adjusted ideal body weight • Capping body surface area at 2.___m2. Please fill in the blank (e.g. 2.0 m2, 2.2 m2, etc.) • Other (please specify) _________________
Tailored Feedback Intervention • Feedback to these oncologists will be given immediately after completion of baseline survey, based on responder type (full-dose vs. other) • Full-dose group will receive reinforcement that practice supported by evidence & summary of evidence available • Under-dosing group will receive feedback that practice is not supported by current evidence & summary of evidence
Tailored Feedback Intervention Feedback also tailored to degree of agreement or disagreement with specific concerns regarding use of full weight-based dosing: • Survival • Short-term hematologic toxicities • Short-term non-hematologic toxicities • Long-term toxicities
Analyses • Study design • Pretest posttest, no control group (intervention reaches entire target population) • Primary outcome • Proportion of oncologists reporting full weight dosing after intervention • Secondary outcome • Proportion of oncologists switching to full weight dosing for breast cancer & switching to full weight dosing for other solid tumors
Exploratory Analyses • Logistic regression model • Dependent variable • Full weight dosing at baseline, dichotomous • Independent variables • Physician factors (demographics, degree of specialization, enrollment of pts onto clinical trials, pt volume, frequency of call, availability of physician extenders, receiving personal feedback about practice patterns) • Practice (university affiliation, cooperative group participation, availability of std chemo orders and/or integrated guidelines, participation in an improvement program)