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