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

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.

Conditions

• Vulvar Cancer
• Vulvar Intraepithelial Neoplasia

Interventions

BEHAVIORAL

standardized care (Intervention I)

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.

BEHAVIORAL

Standardized care + WOMAN-PRO II program (Intervention II)

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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Cantonal Hospital of Lucerne, Switzerland

  collaborator UNKNOWN

• St.Gallen University of Applied Sciences

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• Switzerland

Study Locations