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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Vulvar Cancer
- Sponsor
- St.Gallen University of Applied Sciences
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Changes in symptom prevalence
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Changes in symptom prevalence
Time Frame: Change from baseline symptom prevalence at 6 months, measured on the following points of time: diagnosis, 7 days post-surgery, week two after discharge, week twelve and week 24 after surgery
The primary endpoint of the quantitative study is symptom prevalence, defined as a number of occurring symptoms on predefined time points from diagnosis (t0) across repeated measurements to follow-up assessment at six months after surgery (t4) Symptom prevalence after surgical treatment of vulvar neoplasia will be measured with the German WOMAN-PRO symptom diary. This self-report patient-reported outcome measure covers 31 symptoms occurring after surgery: 15 wound-related symptoms, 5 difficulties in daily life and 11 items that inquire about psychosocial feelings, thoughts or activities. For wound-related symptoms and difficulties in daily life, women are asked to rate how frequently they experienced the symptom/difficulty during the last seven days (never, for 1-2 days, 3-4 days, or 5-7 days).
Secondary Outcomes
- Changes in the Health-related quality of life(Change from baseline health-related quality of life at 6 months)
- Changes in clinical outcomes(change from baseline clinical outcomes at 6 months)
- Process outcomes(6 months (baseline - 24 weeks following surgery))
- Changes in symptom severity(Change from baseline symptom severity at 6 months.)
- Changes in functional status(Change from baseline functional status at 6 months.)
- Changes in Uncertainty-Mishel Uncertainty in Illness Scale (MUIS)(Change from baseline uncertainty at 6 months.)
- Changes in the perceived social support(change form baseline perceived social support at 6 months)
- Changes in Resilience(Change from baseline reslilience at 6 months)
- Changes in Patient Assessment of Chronic Illness Care(change from baseline Patient Assessment of Chronic Illness Care at 6 months)
- Socio-demographic outcomes(baseline)
- Changes in Assessment of Chronic Illness Care(Change from baseline assessment of chronic illness care at 6 months.)
- economic evaluation(6 months (baseline - 24 weeks following surgery))