WOMAN’S CANCERFOUNDATIONWell Woman Clinic
   Breast Cancer   Cervical Cancer   Endometrial cancer   Ovarian Cancer
Worldwide Incidence and mortality                 ANNUAL NEW      ANNUAL DEATHS                 CASES   BREAST        700,...
Early detectionDownstage cancer to improve outcomes and reduce mortality
Setting up an Integrated Screening Program in existinggovernment run hospitals and Primary health centers:Problems…   Hea...
Well Woman Clinic Concept   Integrated cost effective approach of    combining a routine health check up with    screenin...
GOALS…   To promote the concept of free standing Well    Woman’s Clinics to improve outcomes from    lethal cancers affec...
SCREENING AND EARLY CANCER DETECTION OF BREAST ANDGYNECOLOGICAL CANCERSBACKGROUND
BREAST CANCER   Breast cancer is the most prevalent cancer in    the world today. 4.4 million Women are alive    today in...
   LOW RESOURCE COUNTRIES ARE BURDENED    WITH 50% OF BREAST CANCER CASES AND 60%    OF DEATHS DUE TO BREAST CANCER
Global cancer statistics, CA Cancer J Clin2011;61;69-90;   Breast cancer is the most frequently    diagnosed cancer and t...
Breast Cancer   Downstage Breast Cancer from Stage 3 and 4    to Stage 1 and 2A reducing mortality from    20-57% (before...
CERVICAL CANCER   There are 1.4 million women worldwide with    cervical cancer   7 million worldwide may have precancer...
Cervical Cancer   Globally nearly 500,000 new cases of cervical    cancers are reported yearly with 285,000    deaths, ab...
Cervical CancerAim is to                                           Prognosis: 5yeardownstage                              ...
SCREENING AND EARLY CANCER DETECTIONSTRATEGY: CERVICAL CANCER
CERVICAL CANCER: SCREEN AND TREATAPPROACH STRATEGY   HPV DNA TESTING   CRYOTHERAPY FOR SCREEN POSITIVE SMALL    LESIONS...
SCREENING AND EARLY CANCER DETECTIONSTRATEGY: BREAST CANCER
BREAST CANCER SCREENING STRATEGY   Screening Clinical Breast Examination   Screen positive cases   Ultrasound breast ex...
Ultrasound: Advantages   Portable equipment easy to transport and for use in mobile    clinics   No need to recall for a...
Screening Mammography: Why not suitablein low resource settings   Expensive to set up   Resource intensive modality   P...
Screening Mammography:Limitations   10-15% or higher recall rate is to be expected for    women undergoing screening mamm...
SCREENING AND EARLY CANCER DETECTIONSTRATEGY: OVARIAN CANCER
Ovarian Cancer: Early detection   Goff and others have reported that symptoms    that were associated with ovarian cancer...
Ovarian Cancer: Early detection   A symptom index was considered positive if any    of the following symptoms occurred > ...
ENDOVAGINAL SONOGRAPHYNORMAL OVARY   OVARIAN CANCER
SCREENING AND EARLY CANCER DETECTIONSTRATEGY: ENDOMETRIAL CANCER
ENDOMETRIAL CANCER EARLYDETECTION   Assessment of the endometrial stripe in    women with post menopausal bleeding
ENDOVAGINAL SONOGRAPHY                            ENDOMETRIAL CANCERNORMAL ENDOMETRIAL LINING
FUTURE STRATEGIES   BREAST CANCER: AUTOMATED WHOLE BREAST    SCREENING ULTRASOUND MAY BE A VIABLE    ALTERNATIVE TO SCREE...
FUTURE STRATEGIES…….   CERVICAL CANCER VACCINE……   USE OF TUMOR MARKERS FOR EARLY    DIAGNOSIS OF OVARIAN CANCER…….
Proposed Pilot Project sites                             Cambodia                     India            Brazil
2012Proposed Clinic locations   Nova Andradina, Mato Grosso do Sul, Brazil   Phnom Penh, Cambodia   Calcutta, IndiaTARG...
EARLY CANCER DETECTION STRATEGYSCREENING EXAMINATION Cervical cancer: Age group: 30 through 59 at three  year intervals ...
EARLY CANCER DETECTION STRATEGY   BREAST CANCER: CBE and BUS followed by FNAB    of screen and Ultrasound positive cases...
KEY PROGRAM COMPONENTS                         CANCER                        SCREENING                        AND EARLY   ...
CLINIC OPERATIONS: LAYOUT                                                Examination room 1: Well Woman Exam  RECEPTION/RE...
CLINIC OPERATIONS: SPECIAL   EQUIPMENT/SUPPLIES        OFFICE/ RECEPTION                    Examination room 1: Well Woman...
CLINIC OPERATIONS: PERSONNEL   RECEPTIONIST/CLERK   NURSE   RADIOLOGIST   GYNECOLOGIST [CLINIC DIRECTOR]   MEDICAL SO...
CLINIC ADMINSTRATION   Regional Director   Clinic Director   Volunteer Committee: Local community    leaders, physician...
PUBLIC AWARENESS AND OUTREACH:TARGET                     TOTAL NO OF WOMEN                     EXAMINEDBREAST CANCER      ...
TRAINING: School of Breast and GynecologicalCancer Diagnosis and Management   Training at Site   Videoconference   Tele...
Well Woman Clinic Concept: TrainingComponent                             SONOGRAPHER    RADIOLOGY FACULTY        FACULTY...
   GYNECOLOGY    FACULTY           CYTOPATHOLOGY   HPV DNA Testing   FACULTY                      FNAB techniques   Cry...
Clinic Administrative Committee   To provide space and set up for Training at    Clinic sites   Oversee Telemedicine set...
RESEARCH: Clinic Level MEDICAL SOCIAL WORKER OFFICE CLERK NURSEEMR and Patient data entry
RESEARCH COMPONENTData collection and measurement   Population registry of the community served to determine    number of...
   Stage distribution of screen detected breast and cervical    cancers: Indicates potential for reduction in absolute   ...
Confounding variable/studylimitations:   An organized screening program is a novel healthcare    intervention in these co...
   The screening strategy has to be adapted to conform    to local and national guidelines making it difficult to    test...
Timetables/project management   The study period will be for a total of six years.   The investigators will include sele...
Performance Indicator                     Acceptable outcomeParticipation rate                           70%Additional Ima...
Reporting of findings:   Initial data will be analyzed at the end of three years    and presented at appropriate scientif...
Womans Cancer FoundationAdministrative structure
WCF Headquarters                    Houston, TexasSOUTH AMERICA                                 ASIA                      ...
Governing Body                            President                     Public                         Program Manager    ...
Our International PartnersCambodia: Sihanouk Hospital, Phnom Penhhttp://www.sihosp.org/Brazil: Barretos Cancer Hospital. N...
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Woman's Cancer Foundation Well Woman Clinic Project design

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2012 Project design of an Integrated Well Woman Clinic combining a Women's Health assessment with Screening and Early Diagnosis of Breast and Gynecological Cancers

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Woman's Cancer Foundation Well Woman Clinic Project design

  1. 1. WOMAN’S CANCERFOUNDATIONWell Woman Clinic
  2. 2.  Breast Cancer Cervical Cancer Endometrial cancer Ovarian Cancer
  3. 3. Worldwide Incidence and mortality ANNUAL NEW ANNUAL DEATHS CASES BREAST 700,000 270,000 CERVICAL 450,000 240,000 OVARIAN 125,000 75,000 ENDOMETRIAL 150,000 TOTAL 1.425 MILLION 585,000
  4. 4. Early detectionDownstage cancer to improve outcomes and reduce mortality
  5. 5. Setting up an Integrated Screening Program in existinggovernment run hospitals and Primary health centers:Problems… Health care facilities are not easily accessible to rural poor population Are over utilized, understaffed and underfunded An asymptomatic woman is unlikely to make use of a screening program in such a setting
  6. 6. Well Woman Clinic Concept Integrated cost effective approach of combining a routine health check up with screening and early diagnosis of Breast and Gynecological cancers delivered through fixed site or mobile clinics
  7. 7. GOALS… To promote the concept of free standing Well Woman’s Clinics to improve outcomes from lethal cancers affecting women The WCF clinic and the strategy adopted for screening should serve as a model for establishment of a chain of similar clinics to be funded by NGO’S and local and national charities.
  8. 8. SCREENING AND EARLY CANCER DETECTION OF BREAST ANDGYNECOLOGICAL CANCERSBACKGROUND
  9. 9. BREAST CANCER Breast cancer is the most prevalent cancer in the world today. 4.4 million Women are alive today in whom breast cancer was diagnosed within the last five years Over 1 million new cases of Breast cancer will be reported worldwide
  10. 10.  LOW RESOURCE COUNTRIES ARE BURDENED WITH 50% OF BREAST CANCER CASES AND 60% OF DEATHS DUE TO BREAST CANCER
  11. 11. Global cancer statistics, CA Cancer J Clin2011;61;69-90; Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females, accounting for 23% of the total cancer cases and 14% of the cancer deaths.
  12. 12. Breast Cancer Downstage Breast Cancer from Stage 3 and 4 to Stage 1 and 2A reducing mortality from 20-57% (before intervention) to 82-92% (after intervention)
  13. 13. CERVICAL CANCER There are 1.4 million women worldwide with cervical cancer 7 million worldwide may have precancerous lesions that need to be identified and treated before they turn cancerous and lethal The highest absolute numbers of cervical cancer cases occur in Asia
  14. 14. Cervical Cancer Globally nearly 500,000 new cases of cervical cancers are reported yearly with 285,000 deaths, about 85% of these cases occur in the developing countries where screening programs are not established
  15. 15. Cervical CancerAim is to Prognosis: 5yeardownstage survivalfrom Stage 3 Stage 1 A Micro invasive 99%to 4 to Stage1 to reduce Stage 1 B Small confined to 80-90%morbidity cervixand mortalityresulting Stage 3 and 4 Local and distant 15 to 40%from cervical spreadcancer
  16. 16. SCREENING AND EARLY CANCER DETECTIONSTRATEGY: CERVICAL CANCER
  17. 17. CERVICAL CANCER: SCREEN AND TREATAPPROACH STRATEGY HPV DNA TESTING CRYOTHERAPY FOR SCREEN POSITIVE SMALL LESIONS LEEP FOR LARGER LESIONS
  18. 18. SCREENING AND EARLY CANCER DETECTIONSTRATEGY: BREAST CANCER
  19. 19. BREAST CANCER SCREENING STRATEGY Screening Clinical Breast Examination Screen positive cases Ultrasound breast examination Fine needle Aspiration of palpable masses that appear suspicious for cancer on ultrasound
  20. 20. Ultrasound: Advantages Portable equipment easy to transport and for use in mobile clinics No need to recall for additional imaging evaluation as in mammography Sonographic examination of the breast is better tolerated by women due to lack of the need for breast compression Fine needle aspiration biopsy feasible: Procedure is cytology based and similar to PAP smears. US is used as the imaging guide to obtain the sample
  21. 21. Screening Mammography: Why not suitablein low resource settings Expensive to set up Resource intensive modality Poor sensitivity in women with dense breasts Mammographic findings of breast masses and focal asymmetry need additional sonographic evaluation Minimally invasive biopsy procedures for mammographic findings requires stereotactic biopsy equipment which are expensive and time consuming
  22. 22. Screening Mammography:Limitations 10-15% or higher recall rate is to be expected for women undergoing screening mammography requiring an additional clinic visit Breast compression required for mammography involves patient discomfort, and may be less well tolerated and accepted Telemedicine impractical FNAB[fine needle aspiration biopsy] is not an option to sample abnormalities detected by this modality
  23. 23. SCREENING AND EARLY CANCER DETECTIONSTRATEGY: OVARIAN CANCER
  24. 24. Ovarian Cancer: Early detection Goff and others have reported that symptoms that were associated with ovarian cancer were pelvic abdominal pain, urinary frequency/urgency, increased abdominal size and bloating and difficulty eating/feeling full. These symptoms are particularly significant if present for less than year and present > 12 days per month.
  25. 25. Ovarian Cancer: Early detection A symptom index was considered positive if any of the following symptoms occurred > 12 times per month and present for < 1 year: Pelvic/abdominal pain, increased abdominal size/bloating, difficulty eating/feeling full. In the confirmatory sample the index had a sensitivity of 56.7% sensitivity for early disease. Specificity was 90% for women > 50 years
  26. 26. ENDOVAGINAL SONOGRAPHYNORMAL OVARY OVARIAN CANCER
  27. 27. SCREENING AND EARLY CANCER DETECTIONSTRATEGY: ENDOMETRIAL CANCER
  28. 28. ENDOMETRIAL CANCER EARLYDETECTION Assessment of the endometrial stripe in women with post menopausal bleeding
  29. 29. ENDOVAGINAL SONOGRAPHY ENDOMETRIAL CANCERNORMAL ENDOMETRIAL LINING
  30. 30. FUTURE STRATEGIES BREAST CANCER: AUTOMATED WHOLE BREAST SCREENING ULTRASOUND MAY BE A VIABLE ALTERNATIVE TO SCREENING MAMMOGRAPHY AND NEEDS TO BE STUDIED TO TEST EFFICACY AND COST EFFECTIVENESS
  31. 31. FUTURE STRATEGIES……. CERVICAL CANCER VACCINE…… USE OF TUMOR MARKERS FOR EARLY DIAGNOSIS OF OVARIAN CANCER…….
  32. 32. Proposed Pilot Project sites Cambodia India Brazil
  33. 33. 2012Proposed Clinic locations Nova Andradina, Mato Grosso do Sul, Brazil Phnom Penh, Cambodia Calcutta, IndiaTARGET POPULATION Each clinic would serve an approximate target population of about 9000-15000 eligible women
  34. 34. EARLY CANCER DETECTION STRATEGYSCREENING EXAMINATION Cervical cancer: Age group: 30 through 59 at three year intervals Breast cancer: Age group: 35 through 65 at three year intervalsDIAGNOSTIC EXAMINATION IN SYMPTOMATIC WOMEN Ovarian and Endometrial cancer: Age group 50 through 69 years
  35. 35. EARLY CANCER DETECTION STRATEGY BREAST CANCER: CBE and BUS followed by FNAB of screen and Ultrasound positive cases CERVICAL CANCER: HPV DNA followed by Cryotherapy or LEEP : Screen and treat approach Ovarian and Endometrial cancer: Endometrial and Transvaginal ovarian sonography in symptomatic women
  36. 36. KEY PROGRAM COMPONENTS CANCER SCREENING AND EARLY DETECTION CLINICAL MEDICAL RESEARCH TRAINING PUBLIC REFERRAL AWARENESS/ NETWORK OUTREACH/ ADVOCACY
  37. 37. CLINIC OPERATIONS: LAYOUT Examination room 1: Well Woman Exam RECEPTION/REGISTRATION /EMR: Nurse RECEPTIONIST Well Woman Examination, CBE, Routine blood tests, HPV DNA testing Examination room 2: Sonography Examination room 3: Procedures Radiologist/Sonographer Gynecologist/Pathologist Screening and Diagnostic BreastFNAB of Breast masses, Colposcopy and LEEP or Ultrasound Cryotherapy Endometrial Sonography Ovarian Sonography
  38. 38. CLINIC OPERATIONS: SPECIAL EQUIPMENT/SUPPLIES OFFICE/ RECEPTION Examination room 1: Well Woman Exam PC/EMR HPV DNA Kits Examination room 3: Procedures Examination room 2: SonographyColposcope, FNAB Kits, Digital Microscope, Portable Ultrasound System telemedicine set up
  39. 39. CLINIC OPERATIONS: PERSONNEL RECEPTIONIST/CLERK NURSE RADIOLOGIST GYNECOLOGIST [CLINIC DIRECTOR] MEDICAL SOCIAL WORKER [RESEARCH DATA COORDINATOR
  40. 40. CLINIC ADMINSTRATION Regional Director Clinic Director Volunteer Committee: Local community leaders, physicians, NGO’s OR Partner organization
  41. 41. PUBLIC AWARENESS AND OUTREACH:TARGET TOTAL NO OF WOMEN EXAMINEDBREAST CANCER 3000/clinic/yearCERVICAL CANCER 5000/clinic/yearOVARIAN CANCER 500/clinic/yearENDOMETRIAL CANCER 250/ clinic/year
  42. 42. TRAINING: School of Breast and GynecologicalCancer Diagnosis and Management Training at Site Videoconference Telemedicine consultation
  43. 43. Well Woman Clinic Concept: TrainingComponent  SONOGRAPHER  RADIOLOGY FACULTY FACULTY:  Breast Sonography  Breast Sonography  Ovarian Sonography  Ovarian Sonography  Endometrial  Endometrial Sonography Sonography  Biopsy guidance
  44. 44.  GYNECOLOGY FACULTY CYTOPATHOLOGY HPV DNA Testing FACULTY FNAB techniques Cryotherapy Slide preparation Loop excision Interpretation training Scanning of slide and CBE Telemedicine
  45. 45. Clinic Administrative Committee To provide space and set up for Training at Clinic sites Oversee Telemedicine set up at the clinic
  46. 46. RESEARCH: Clinic Level MEDICAL SOCIAL WORKER OFFICE CLERK NURSEEMR and Patient data entry
  47. 47. RESEARCH COMPONENTData collection and measurement Population registry of the community served to determine number of eligible women in the target population Compliance rate: To determine potential for effectiveness of the program Prevalence rate at initial screening for breast and cervical cancer: Provides estimates of sensitivity, lead time and rate of interval cancers, sojourn time and predictive value
  48. 48.  Stage distribution of screen detected breast and cervical cancers: Indicates potential for reduction in absolute screen-detected cancers rate of advanced cancers. The same for Endometrial and ovarian cancer in the symptomatic population Rate of advanced breast and cervical cancers: Early surrogate of mortality. The same for Endometrial and ovarian cancer in the symptomatic population Sensitivity, specificity, Positive predictive value for each screening method
  49. 49. Confounding variable/studylimitations: An organized screening program is a novel healthcare intervention in these communities; hence participation of eligible women in the target population is the confounding variable. A screening program which essentially aims to draw in asymptomatic women in a low resource setting will face a challenge of convincing women who are otherwise healthy to attend a health clinic given the social constraints on women with limited financial resources and maternal obligations.
  50. 50.  The screening strategy has to be adapted to conform to local and national guidelines making it difficult to test efficacy of a similar strategy combined screening program because of inherent differences in methodology of cancer screening necessitated by local and national guidelines’ The study design is not that of a randomized clinical trial so mortality reduction cannot be ascertained from implementation of such a screening strategy
  51. 51. Timetables/project management The study period will be for a total of six years. The investigators will include select members of the Medical Advisory board, Clinic director, a physician from the partner organization Project will be managed by local clinic administrative and medical team in consultation with the medical advisory council members who are listed as Clinical Investigators
  52. 52. Performance Indicator Acceptable outcomeParticipation rate 70%Additional Imaging at time of screening 5%Pre treatment diagnosis of malignancy 70 %Insufficient FNA results 25%Benign to malignant ratio 50 %Re invitation within specified period 95%
  53. 53. Reporting of findings: Initial data will be analyzed at the end of three years and presented at appropriate scientific meetings Final data at the end of a six year study period will be analyzed and published in peer reviewed journals.
  54. 54. Womans Cancer FoundationAdministrative structure
  55. 55. WCF Headquarters Houston, TexasSOUTH AMERICA ASIA AFRICABrazil/Guatemala India, Uganda Cambodia Well Womans Clinic Clinic Administrative Committee
  56. 56. Governing Body President Public Program Manager Awareness Council: Board of Trustees Volunteers Medical Patrons and Advisory Supporters Council National and WCF Clinic AdministrationInternational medical Regional Director School of experts drawn from Administrative committee: Breast and fields of Oncology, Partner organization/ GynecologicalCancer screening and Local community & Clinic Staff Cancer Public Health Management
  57. 57. Our International PartnersCambodia: Sihanouk Hospital, Phnom Penhhttp://www.sihosp.org/Brazil: Barretos Cancer Hospital. Nova Andradinahttp://www.cliquecontraocancer.com.br/India: Manipal Group. North Goahttp://www.manipalgroup.com/Breast Health Global Initiative
  58. 58. Thank you!

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