Vulvar Cancer Clinical Trial
— WOMAN-PROIIOfficial 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
Verified date | January 2016 |
Source | St.Gallen University of Applied Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Switzerland | Institute for Applied Nursing Sciences IPW, University of Applied Sciences FHS St. Gallen, Switzerland | St. Gallen |
Lead Sponsor | Collaborator |
---|---|
St.Gallen University of Applied Sciences | Cantonal Hospital of Lucerne, Switzerland, Cantonal Hospital of St. Gallen, Medical University of Vienna, University Hospital Inselspital, Berne, University Hospital, Basel, Switzerland |
Switzerland,
Gafner D, Eicher M, Spirig R, Senn B. [Between anxiety and hope: the experiences of women with vulval intraepithelial neoplasia during their illness trajectory - a qualitative approach]. Pflege. 2013 Apr;26(2):85-95. doi: 10.1024/1012-5302/a000273. German — View Citation
Senn B, Eicher M, Mueller MD, Engberg S, Spirig R. [Needs based nursing care in gynecology. "My symptom diary"]. Krankenpfl Soins Infirm. 2012;105(5):32-3. German. — View Citation
Senn B, Eicher M, Mueller MD, Gafner D, Engberg S, Spirig R. [Development and validation of a patient reported outcome instrument for women with vulvar cancers and surgical treatment - a mixed method study]. Pflege. 2013 Feb;26(1):65-8. doi: 10.1024/1012- — View Citation
Senn B, Eicher M, Mueller MD, Hornung R, Fink D, Baessler K, Hampl M, Denhaerynck K, Spirig R, Engberg S. A patient-reported outcome measure to identify occurrence and distress of post-surgery symptoms of WOMen with vulvAr Neoplasia (WOMAN-PRO) - a cross — View Citation
Senn B, Mueller MD, Cignacco EL, Eicher M. Period prevalence and risk factors for postoperative short-term wound complications in vulvar cancer: a cross-sectional study. Int J Gynecol Cancer. 2010 May;20(4):646-54. doi: 10.1111/IGC.0b013e3181d92723. — View Citation
Senn B, Mueller MD, Hasenburg A, Blankenstein T, Kammermann B, Hartmann A, Donovan H, Eicher M, Spirig R, Engberg S. Development of a postsurgical patient-reported outcome instrument for women with vulvar neoplasia. Oncol Nurs Forum. 2012 Nov;39(6):E489-9 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in symptom prevalence | 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). | 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 | No |
Secondary | Changes in symptom severity | Symptom severity after surgical treatment of vulvar neoplasia will also be measured with the 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 the psychosocial symptoms/issues, women are asked to assess the severity of symptoms (not at all, a little bit, quite a bit, very much). | Change from baseline symptom severity at 6 months. | No |
Secondary | Changes in Uncertainty-Mishel Uncertainty in Illness Scale (MUIS) | The Mishel Uncertainty in Illness Scale (MUIS) is a 30-item scale detecting uncertainty in symptomatology, diagnosis, treatment, relationship with caregivers, and planning for the future. | Change from baseline uncertainty at 6 months. | No |
Secondary | Changes in the Health-related quality of life | The validated German and English Short Form (SF-36) will be administered. It utilizes scale profile, 36 questions and a one-week recall period. It contains eight subscale scores: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Items are rated on a 3-6-point Likert scale. | Change from baseline health-related quality of life at 6 months | No |
Secondary | Changes in the perceived social support | The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale designed to assess three aspects of perceived social support. The tree aspects comprise support from friends, family, and significant others. | change form baseline perceived social support at 6 months | No |
Secondary | Changes in Resilience | Resilience refers to positive adaptation following stress or trauma. The original Connor-Davidson Resilience Scale brief version (CD-RISC 10) is a 10-item scale assessing resilience during the last month, with higher scores indicating higher resilience capacity. | Change from baseline reslilience at 6 months | No |
Secondary | Changes in Patient Assessment of Chronic Illness Care | The Patient Assessment of Chronic Illness Care (PACIC) instrument evaluates the quality and patient-centeredness of chronic illness care based on the Chronic Care Model (CCM) | change from baseline Patient Assessment of Chronic Illness Care at 6 months | No |
Secondary | Socio-demographic outcomes | Socio-demographic outcomes for patients will be collected with an 11-items form concerning age, marital status, number of children, education, employment status, living situation, post surgical wound management at home, and health insurance. The instrument was developed for patients following vulvar surgical treatment. | baseline | No |
Secondary | Changes in clinical outcomes | Clinical outcomes for patients will be collected with a 16-items form concerning diagnosis, cancer stage, initial treatment, and wound treatment. The instrument was developed for patients following vulvar surgical treatment. | change from baseline clinical outcomes at 6 months | No |
Secondary | Changes in functional status | The functional status, referring to the capacity to perform a variety of activities that are normal for most people, will be measured with the Eastern Cooperative Oncology Group Performance Status (ECOG-PS). ECOG-PS is a one item five-point scale using verbal descriptors, ranging from 0 "fully active" to 5 "dead". It was developed in 1960 for cancer patients and has been widely used by physicians and researchers to assess how a patient's disease is progressing and how it affects the daily living abilities. | Change from baseline functional status at 6 months. | No |
Secondary | Changes in Assessment of Chronic Illness Care | The Assessment of Chronic Illness Care (ACIC) questionnaire was developed to assess if provided care is in alignment with the Chronic Care Model (CCM). The CCM comprises six areas: the organization of the health care system, the community linkage, self-management, decision support, delivery system design, and the clinical information system. The ACIC addresses how well a practice team or organization integrates the Chronic Care Model elements. Responses can be related to four descriptive levels from A "fully implemented" to D "little or none" implementation of the intervention. | Change from baseline assessment of chronic illness care at 6 months. | No |
Secondary | Process outcomes | The collection of three process outcomes during the implementation of a complex intervention program will allow to draw conclusions about potential barriers and facilitators of the interaction between patient and gynecology-oncology nurse specialist during the counseling intervention. (1) Counseling competencies and details of the complex interaction between patients and the gynecology-oncology nurse specialist will be assessed during the study period by audio-recording a random sample of 15-20 counseling sessions.(2) The gynecology-oncology nurse will document her experiences after each counseling session by keeping a diary to reveal her personal situation during the counseling process. (3) The WOMAN-PRO II program teacher will contact the gynecology-oncology nurse specialists every eight weeks and document the content of the discussions by keeping a diary after each contact. | 6 months (baseline - 24 weeks following surgery) | No |
Secondary | economic evaluation | Economic evaluation methods will be performed according to the recommendations of the NICE Reference Case. The economic evaluation will consist of a within-trial analysis and will compare direct costs and six-month outcomes of patients randomized to intervention II versus intervention I. Direct hospital costs will be the primary perspective. The study will record length of hospital stay, primary surgery costs, readmission, costs concerning intervention I, costs concerning intervention II, follow-up costs, patients non-productive time, and mortality. Comparison will be made between baseline and follow-up to estimate incremental cost-effectiveness ratio (ICER) comparing intervention II group with intervention I group in terms of the primary outcome measure (symptom prevalence) and costs. | 6 months (baseline - 24 weeks following surgery) | No |
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