The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence

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Brief Title

The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence

Official Title

The Impact of the Self-management Intervention "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence: A Mixed-Methods Project

Brief Summary

      In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom
      distress and complications, which have an impact on a woman's quality of life and contribute
      to high health care costs. For the majority of the patients, symptom and distress can be
      reduced if adequate treatment is provided. This study aims to test possible differences
      between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in
      women with vulvar neoplasia after surgical treatment.

      In a sequential explanatory mixed-methods project, a randomized phase II study will be
      followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically
      will participate in the randomized trial in four Swiss hospitals and one Austrian hospital.
      After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to
      standardized care and the WOMAN-PRO II program. The standardized care group will receive a
      set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II
      program group will obtain counseling sessions by specially trained gynecology-oncology nurse
      specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge,
      week twelve and week 24 after surgery. The primary outcome of this study is symptom
      prevalence. Secondary outcomes will be collected for explorative reasons and include symptom
      distress, uncertainty, quality of life, social support, resilience, quality of care,
      sociodemographic and medical characteristics, post-surgical complications, functional status,
      cost evaluation and process outcomes. Quantitative data will be collected at the counseling
      points of time and analyzed by using mixed linear regression analysis. Twenty interviews will
      be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be
      conducted with twelve gynecology-oncology nurse specialists in order to better understand to
      which degree the interventions meet individual needs as well as to identify remaining
      barriers and enablers for the implementation of symptom self-management. Qualitative data
      will be analyzed by using thematic analysis and a critical hermeneutic reflection.

      This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence,
      patient-reported outcomes and clinical parameters, and inform the design of a possible phase
      III study on the clinical efficacy of the program.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Changes in symptom prevalence

Secondary Outcome

 Changes in symptom severity

Condition

Vulvar Cancer

Intervention

standardized care (Intervention I)

Study Arms / Comparison Groups

 Standardized care
Description:  During treatment and routine follow-up consultations, patients randomized to standardized care will be provided with usual care and a predefined set of additional written information leaflets about supportive care options in the early treatment phase designed for the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

45

Start Date

September 2013

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of vulvar intraepithelial neoplasia (VIN) or vulvar cancer (primary
             diagnosis or recurrent neoplasia)

          -  Surgical treatment of VIN or vulvar cancer in one of the designated hospitals

          -  Age > 18

        Exclusion Criteria:

          -  Patients being judged by a physician or by a gynecology-oncology nurse specialist as
             not being capable to participate in the trial and to complete the questionnaire due to
             cognitive, linguistic, emotionally or physically reasons.

          -  Patients in concurrently psychiatric treatment

          -  Terminal illness
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Beate Senn, PhD, RN, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT01986725

Organization ID

WOMAN-PRO II program


Responsible Party

Sponsor

Study Sponsor

St.Gallen University of Applied Sciences

Collaborators

 University Hospital Inselspital, Berne

Study Sponsor

Beate Senn, PhD, RN, Principal Investigator, Institute for Applied Nursing Sciences IPW, University of Applied Sciences FHS St. Gallen, Switzerland


Verification Date

January 2016