At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Brief
A Phase 2 clinical trial evaluating standardized care (Intervention I) and Standardized care + WOMAN-PRO II program (Intervention II) for Vulvar Cancer and Vulvar Intraepithelial Neoplasia. Completed, enrolled 45 participants across 1 site.
Detailed 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 Details
Timeline
Interventions
During treatment and routine follow-up consultations, patients randomized to standard 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.Usual care includes treatment during hospitalization by the gynecologist and the nurses according to the existing guidelines. At each follow-up visit, the gynecologist will conduct a physical examination. The follow-ups include also treatment of adverse effects of the therapy and rehabilitation.
This intervention is in addition to standard care. Nurse-led follow-up consultations with the WOMAN-PRO II program complementary to physician appointments have the goal to support women's self-management abilities in order to deal with occurring symptoms and related distress. Content of the WOMAN-PRO II program designed for this study is summarized in a handbook for professionals including patient clinical pathways and nurse interventions, supplemented by a patient booklet (paper based and electronic version) with tailored information according to patients' needs. The program includes five consultations with an approximate total duration of two hours.