The IMAP Study Improving Management of Mildly Abnormal Pap Smears

NCT ID: NCT00119509

Last Updated: 2007-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-04-30

Brief Summary

The study compares the psychosocial outcomes of different management strategies for women with minor atypia (including 'HPV effect') detected on Pap smears: conventional management (a repeat Pap smear at 6 months) versus Human papillomavirus (HPV) DNA testing, a new method proposed for the management of minor atypia and the informed choice of either management supported by a decision aid.

The study examines women's informed preferences for each of these options and compares the psychosocial outcomes in women who are or are not given the choice of management.

HPV DNA testing offers considerable changes to the management of women with minor atypia and there is evidence from the USA which suggests that the use of HPV DNA testing as a triage strategy is effective for women within this group (Solomon et al 2001). The introduction of HPV DNA testing may bring both benefits and harms to women. These harms and benefits are not well understood. Examination of the psychosocial outcomes of HPV DNA testing compared to conventional management and women's preferences for each is needed to guide decisions concerning HPV DNA testing in cervical screening in Australia and also internationally.

Detailed Description

Women diagnosed with minor atypia following a routine Pap smear will be randomised into one of the three management arms of the study (a) HPV DNA test, (b) Decision Aid (DA) with choice of management, or (c) a 6 month repeat Pap smear (conventional management). Women who are allocated to the HPV DNA arm and the repeat Pap will receive standard information about their management strategy. Women allocated to the decision aid arm will receive information about HPV DNA testing and 6 month repeat Pap in a decision aid format as an adjunct to usual clinical care and asked to indicate their preference for management. Women in this arm will receive the management strategy of their choice (HPV DNA or repeat Pap). The impact of the Decision Aid will be assessed and psychosocial impact of each management strategy will be followed up over the short, medium and long term.

Management and Clinical outcomes: Data will be collected on the taking and timing of Pap smears, HPV testing and colposcopy as well as findings for each of these tests and any subsequent treatment.

Psychosocial outcomes: Measures will be administered by postal questionnaire at multiple time points across the study. There will be 3 questionnaires: (1) Baseline questionnaire - for all participants recruited into the study; (2) Decision-making evaluation - to assess decision-making in all groups and the impact of the decision aid; (3) Psychosocial impact questionnaire - brief questionnaire (taking approximately 10 minutes to complete) sent at multiple time points to assess the psychosocial impact over time (2 weeks, 3, 6 and 12 months).

Quality of life assessment: Participants will be invited to take part in an interview at 1 month and 12 months post testing (HPV testing or repeat Pap smear) to assess quality of life using standardised validated QOL measures. Interviews will be carried out by an experienced female researcher. Study participants will be given the option to participate in the interview and will be under no obligation to take part if they do not wish to.

Conditions

Cervix Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

HPV DNA testing

Intervention Type: PROCEDURE

Conventional management (repeat Pap smear at 6 months)

Intervention Type: PROCEDURE

Decision aid with choice of management

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women with ONLY the following results on a routine Pap smear:

• Low grade epithelial abnormality;
• Minor changes in squamous cell;
• Minor changes in squamous cells with appearances consistent with Papillomavirus
• Women aged between 18-70 years

Exclusion Criteria

• Women who are pregnant or planning to become pregnant in the next 12 months
• Women with previous Pap smear abnormality for 2 years.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Family Planning Association New South Wales

OTHER_GOV

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: lead

Principal Investigators

Kirsten McCaffery, PhD

Role: STUDY_CHAIR

University of Sydney

Les Irwig, PhD

Role: STUDY_DIRECTOR

University of Sydney

Glenn Salkeld, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Alexandra Barratt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Kirsten Howard, Masters

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Edith Weisberg, Medicine

Role: PRINCIPAL_INVESTIGATOR

Family Planning Association

Locations

North Coast Community Health Centre

Port Macquarie, New South Wales, Australia

Family Planning Association

Sydney, New South Wales, Australia

Taree Community Health Centre

Taree, New South Wales, Australia

Illawarra Women's Health Centre

Warilla, New South Wales, Australia

Family Planning Queensland

Brisbane, Queensland, Australia

Shine SA

Adelaide, South Australia, Australia

Family Planning Western Australia

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

211205_IMAP

Identifier Type: -

Identifier Source: org_study_id