Clinical trial NCT01986725: The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvar Cancer
Vulvar Intraepithelial Neoplasia
Keywords: vulvar neoplasia
vulvar cancer
vulvar intraepithelial neoplasia
self management
symptom management
Lead sponsor: St.Gallen University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Basel, Switzerland
name: Cantonal Hospital of St. Gallen
name: Medical University of Vienna
name: Cantonal Hospital of Lucerne, Switzerland
First posted: 2013-11-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Changes in symptom prevalence
timeFrame: 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
Secondary outcomes:
measure: Changes in symptom severity
timeFrame: Change from baseline symptom severity at 6 months.
measure: Changes in Uncertainty-Mishel Uncertainty in Illness Scale (MUIS)
timeFrame: Change from baseline uncertainty at 6 months.
measure: Changes in the Health-related quality of life
timeFrame: Change from baseline health-related quality of life at 6 months
measure: Changes in the perceived social support
timeFrame: change form baseline perceived social support at 6 months
measure: Changes in Resilience
timeFrame: Change from baseline reslilience at 6 months
measure: Changes in Patient Assessment of Chronic Illness Care
timeFrame: change from baseline Patient Assessment of Chronic Illness Care at 6 months
measure: Socio-demographic outcomes
timeFrame: baseline
measure: Changes in clinical outcomes
timeFrame: change from baseline clinical outcomes at 6 months
measure: Changes in functional status
timeFrame: Change from baseline functional status at 6 months.
measure: Changes in Assessment of Chronic Illness Care
timeFrame: Change from baseline assessment of chronic illness care at 6 months.
measure: Process outcomes
timeFrame: 6 months (baseline - 24 weeks following surgery)
measure: economic evaluation
timeFrame: 6 months (baseline - 24 weeks following surgery)
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Institute for Applied Nursing Sciences IPW, University of Applied Sciences FHS St. Gallen, Switzerland
Study officials:
affiliation: Institute for Applied Nursing Sciences IPW, University of Applied Sciences FHS St. Gallen, Switzerland
name: Beate Senn, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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 sectional study. Gynecol Oncol. 2013 Apr;129(1):234-40. doi: 10.1016/j.ygyno.2012.12.038. Epub 2013 Jan 3.
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.
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. No abstract available. German.
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):E489-98. doi: 10.1188/12.ONF.E489-E498.
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: 10.1024/1012-5302/a000265. No abstract available. German.
citation: 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.
citation: Kofler S, Kobleder A, Ott S, Senn B. The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia six months after surgical treatment and the influence of social support, recurrence, and age: a secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO II. BMC Womens Health. 2020 May 6;20(1):95. doi: 10.1186/s12905-020-00965-z.
citation: Gehrig L, Kobleder A, Werner B, Denhaerynck K, Senn B. [Are written information or counseling (WOMAN-PRO II program) able to improve patient satisfaction and the delivery of health care of women with vulvar neoplasms? Secondary outcomes of a multicenter randomized controlled trial]. Pflege. 2017;30(5):257-269. doi: 10.1024/1012-5302/a000558. Epub 2017 Jun 27. German.
citation: Kobleder A, Raphaelis S, Glaus A, Fliedner M, Mueller MD, Gafner D, Gehrig L, Senn B. Recommendations for symptom management in women with vulvar neoplasms after surgical treatment: An evidence-based guideline. Eur J Oncol Nurs. 2016 Dec;25:68-76. doi: 10.1016/j.ejon.2016.10.003. Epub 2016 Oct 22.