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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

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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


Stage 1 to determine
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.


Stage 1 qol questionnaires
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)


Majority Platinum Resistant

Compliance

All questionnaires were completed to a very high compliance rate with few or no missing data





Schema stage 2

Target Population patients in Stage 1)

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


Most m easure of o varian cancer s ymptoms and t reatment concerns
MOST patients in Stage 1)Measure 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.


Most recent status form to be administered before each cycle
MOST Recent Status Form patients in Stage 1)To be administered before each cycle


  • Translations patients in Stage 1)

  • Statistical and Data – CTC Sydney

  • Contacts- Julie Martyn/Michael Friedlander


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