NCT01986725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

May 21, 2013

Last Update Submit

January 6, 2016

Conditions

Vulvar CancerVulvar Intraepithelial Neoplasia

Keywords

vulvar neoplasiavulvar cancervulvar intraepithelial neoplasiaself managementsymptom management

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (12)

  • Changes in symptom severity

    Change from baseline symptom severity at 6 months.

  • Changes in Uncertainty-Mishel Uncertainty in Illness Scale (MUIS)

    Change from baseline uncertainty at 6 months.

  • Changes in the Health-related quality of life

    Change from baseline health-related quality of life 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

  • +7 more secondary outcomes

Study Arms (2)

Standardized care

ACTIVE COMPARATOR

During treatment and routine follow-up consultations, patients randomized to standardized 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.

Behavioral: standardized care (Intervention I)

Standardized care + WOMAN-PRO II program

ACTIVE COMPARATOR

During treatment and routine follow-up consultations, patients randomized to standardized care + WOMAN-PRO II program will be provided with usual care and nurse-led follow-up consultations with the WOMAN-PRO II program complementary to physician appointments.

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

Interventions

standardized care (Intervention I)BEHAVIORAL

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.

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

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.

Standardized care + WOMAN-PRO II program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sankt Gallen, 9001, Switzerland

Location

Related Publications (9)

  • 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.

    PMID: 23290987RESULT

  • 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.

    PMID: 20686386RESULT

  • 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.

    PMID: 22675922RESULT

  • 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.

    PMID: 23107862RESULT

  • 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.

    PMID: 23384847RESULT

  • 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.

    PMID: 23535473RESULT

  • 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.

    PMID: 32375773DERIVED

  • 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.

    PMID: 28653559DERIVED

  • 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.

    PMID: 27865255DERIVED

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Beate Senn, PhD, RN

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

November 18, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

CH(1)