AzTrials
AzTrials

Vulvar CancerPhase 2WOMAN-PROIINCT01986725

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

A Phase 2 study testing standardized care (Intervention I) and Standardized care + WOMAN-PRO II program (Intervention II) in people with Vulvar Cancer and Vulvar Intraepithelial Neoplasia, run by St.Gallen University of Applied Sciences at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
standardized care (Intervention I) and Standardized care + WOMAN-PRO II program (Intervention II)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
Sep 2013to Nov 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Sankt Gallen, 9001

Other trials in Switzerland

About this study

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

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.

Being tested
standardized care (Intervention I), Standardized care + WOMAN-PRO II program (Intervention II)
Keywords
vulvar neoplasia, vulvar cancer, vulvar intraepithelial neoplasia, self management, symptom management
Medical subject headings
Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standardized care (Intervention I)Behavioural

    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 + WOMAN-PRO II program (Intervention II)Behavioural

    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.

Study groups in NCT01986725
Study groupRoleWhat they receive
Standardized careActive comparatorDuring 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.
Receives: Behavioral: standardized care (Intervention I)
Standardized care + WOMAN-PRO II programActive comparatorDuring 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.
Receives: Behavioral: Standardized care + WOMAN-PRO II program (Intervention II)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. 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).

    Measured: Change from baseline symptom severity at 6 months.

  2. 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.

    Measured: Change from baseline uncertainty at 6 months.

  3. 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.

    Measured: Change from baseline health-related quality of life at 6 months

  4. 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.

    Measured: change form baseline perceived social support at 6 months

  5. 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.

    Measured: Change from baseline reslilience at 6 months

  6. 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)

    Measured: change from baseline Patient Assessment of Chronic Illness Care at 6 months

  7. 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.

    Measured: baseline

  8. 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.

    Measured: change from baseline clinical outcomes at 6 months

  9. 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.

    Measured: Change from baseline functional status at 6 months.

  10. 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.

    Measured: Change from baseline assessment of chronic illness care at 6 months.

  11. 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.

    Measured: 6 months (baseline - 24 weeks following surgery)

  12. 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.

    Measured: 6 months (baseline - 24 weeks following surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986725
Sponsor's protocol ID
WOMAN-PRO II program
Acronym
WOMAN-PROII
Status last verified
Jan 2016
First submitted
21 May 2013
Last updated
7 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23290987

  • 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.

    PubMed 20686386

  • 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.

    PubMed 22675922

  • 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.

    PubMed 23107862

  • 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.

    PubMed 23384847

  • 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.

    PubMed 23535473

  • 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.

    PubMed 32375773

  • 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.

    PubMed 28653559

  • 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.

    PubMed 27865255

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing standardized care (Intervention I) and Standardized care + WOMAN-PRO II program (Intervention II) in people with Vulvar Cancer and Vulvar Intraepithelial Neoplasia, run by St.Gallen University of Applied Sciences at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986725, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in