Vulvar Cancer Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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