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Study Schema

Study Schema. Target Population >18yrs platinum resistant/ refractory epithelial ovarian cancer / > 3 LINES ECOG 0-3 Able to commence treatment within 2wks of registration Sufficient English language skills to complete QoL forms independently. Stage1 50-100 patients

aaron-roberts
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Study Schema

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  1. Study Schema Target Population >18yrs platinum resistant/ refractory epithelial ovarian cancer / > 3 LINES ECOG 0-3 Able to commence treatment within 2wks of registration Sufficient English language skills to complete QoL forms independently • Stage1 • 50-100 patients • Complete 7 QoL • forms • 20 subjects will • participate in • additional QoL • telephone interview Data Collection 4 Treatment cycles or Disease progression REGISTER

  2. Stage 1 To Determine • The symptoms and aspects of HRQL that are rated as most severe, troublesome and important by patients. • The optimal items and questionnaires for measuring these improvements.

  3. Stage 1 QoL Questionnaires • Symptom Representation Questionnaire • FACT-O (includes FOSI) • EORTC QLQ-C30 • EORTC QLQ-OV28 • Patient Data Form • Expected and Perceived Benefit Scale • HAD Scale (Baseline & End of Treatment only) • Herth Hope Index (Baseline & End of Treatment only)

  4. Majority Platinum Resistant Compliance All questionnaires were completed to a very high compliance rate with few or no missing data

  5. Number of Lines of Prior Therapy

  6. Reasons for Starting Chemotherapy

  7. Top 3 symptoms nominated by patients at baseline- (77 patients in Stage 1)

  8. Target Population Informed consent ≥18yrs Histologically confirmed epithelial ovarian or primary peritoneal or primary fallopian tube cancers Recurrent or progressive disease ECOG 0-3 Life expectancy > 3 months Able to commence treatment within 2wks of registration Able to complete questionnaires independently R E G I S T E R • Data Collection • Baseline • Each treatment cycle • One month post completion of treatment or until disease progression • Australian patients – telephone interview Schema – Stage 2

  9. MOSTMeasure of Ovarian cancer Symptoms and Treatment concerns Modification of Patient Data Form- COVERS ALL SYMPTOMS AND ASPECTS OF QOL IDENTIFIED IN STAGE 1 and corroborated by an end of life study in 420 women with ovarian cancer Comprises of 35 individual items on a discrete scale of 0-10, where major symptomatic distress is represented by 10. The first 15 items refer to disease symptoms Items 16 and 17 refer to physical and emotional well-being whilst item 18 is a question referring to overall well-being. 19-35 deals with side effects and other concerns The study will examine the extent of clinical improvement by examining changes in these items from baseline at each time point.

  10. MOST Recent Status FormTo be administered before each cycle

  11. Translations • Statistical and Data – CTC Sydney • Contacts- Julie Martyn/Michael Friedlander

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