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

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Vulvar CancerVulvar 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.

Trial Locations (1)

9001

Institute for Applied Nursing Sciences IPW, University of Applied Sciences FHS St. Gallen, Switzerland, Sankt Gallen

All Listed Sponsors
collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

collaborator

University Hospital, Basel, Switzerland

OTHER

collaborator

Cantonal Hospital of St. Gallen

OTHER

collaborator

Medical University of Vienna

OTHER

collaborator

Cantonal Hospital of Lucerne, Switzerland

UNKNOWN

lead

St.Gallen University of Applied Sciences

OTHER

NCT01986725 - "The Impact of the WOMAN-PRO II Program on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence" | Biotech Hunter | Biotech Hunter