Effectiveness of an App Intervention to Reduce Postsurgical Symptom Distress in Patients With Vulvar Neoplasia

NCT04541784 | Completed

• 1 other identifier: WOMAN-PRO III
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

Despite great advances in surgical therapy in the last decades, symptom relief for women with vulvar neoplasia (vulvar cancer and pre-stage of vulvar cancer) is still not optimal. Guidelines of the National Comprehensive Cancer Network recommend using electronic communication media, e.g. applications ("apps") to relieve symptom distress and foster self-management. However, little is known on how effective these communication technologies are, especially in the field of a rare cancer disease like vulvar neoplasia. This mixed methods project aims to examine the effectiveness of a multidimensional mobile app intervention ("WOMAN-PRO III") focusing on possible improvements due to the new mobile app intervention, which consists of three counselling sessions with a gynaecologic-oncology nurse and the use of the mobile app whenever women want for a period of six months, the online version of the "WOMAN-PRO" diary for symptom assessment, the opportunity to send the data to the gynaecology-oncology nurse, disease and treatment related information and evidence-based recommendations, relevant contact data and a chat function for the anonymous exchange with peers (intervention group) compared to three counselling sessions with a gynaecologic-oncology nurse, where they receive written information (control group). Effectiveness will be examined with respect to symptom induced distress, uncertainty and cost effectiveness in women with vulvar neoplasia after surgical treatment across time. The objective of the qualitative study is to assess women's perceived uncertainty and the acceptability, usability, strengths and weaknesses of the mobile app intervention ("WOMAN-PRO III") from patients' and gynaecology-oncology nurses' perspective.

Conditions

Vulvar Neoplasm

Keywords

mHealth; Postsurgical symptoms; Distress; Uncertainty; Mixed methods

Outcome Measures

Primary Outcomes (1)

• Change of symptom induced distress

  Measured with the "WOMAN-PRO" symptom diary. This instrument focuses on patients' post-surgical symptom experience, regarding frequency and distress. The instrument consists of 36 items covering four domains. On average a patient needs 20 minutes to complete the diary. The instrument showed an excellent item validity (Cronbach's alpha ranging between 0.74 and 0.90) and scale content validity (CVI=1.0) (Senn et al., 2013).

  Between diagnosis / before surgical treatment (t0), day seven post-surgery (t1) and month six post-surgery (t2)

Secondary Outcomes (2)

• Uncertainty

  Between diagnosis / before surgical treatment (t0), day seven post-surgery (t1) and month six post-surgery (t2)

• Cost effectiveness

  During a period of 6 months after diagnosis/surgery

Other Outcomes (2)

• Sociodemographic data

  At diagnosis/before surgery (t0)

• Medical data

  At diagnosis/before surgery (t0)

Study Arms (2)

3 counselling sessions with gynaecology-oncology nurses

ACTIVE COMPARATOR

Patients randomized to the control group will receive standardized care, 3 counselling sessions with a gynaecology-oncology nurse and written information at three points in time during 6 months after diagnosis/surgery.

Other: Three counselling sessions with gynaecology-oncology nurses

Mobile app and 3 counselling sessions (WOMAN-PROIII)

EXPERIMENTAL

Standardized care and three counselling sessions with a gynaecology-oncology nurse and the use of the mobile app "WOMAN-PRO III". Counselling sessions will take place at 3 points in time during 6 months after diagnosis/surgery. Additionally, the gynaecology-oncology nurse will instruct the patient to use the mobile app. It includes a diary for symptom assessment and gives graphical feedback. Further, the app includes disease and treatment related information. If a symptom occurs the app will give an evidence-based recommendation (Kobleder et al., 2016). The patients can use the app whenever they want for a period of six months.

Other: WOMAN-PRO III

Interventions

WOMAN-PRO III OTHER

Standardized care and three counselling sessions with a gynaecology-oncology nurse and the use of the mobile app "WOMAN-PRO III".

Mobile app and 3 counselling sessions (WOMAN-PROIII)

Three counselling sessions with gynaecology-oncology nurses OTHER

Standardized care, three counselling sessions with a gynaecology-oncology nurse.

3 counselling sessions with gynaecology-oncology nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis VIN or vulvar cancer (primary diagnosis or recurrent neoplasia)
• Surgical treatment of VIN or vulvar cancer in one of the designated hospitals
• Sufficient knowledge of the German/Italian language (writing and speaking at level B1)
• Having a smartphone (e.g. iPhone, Samsung), tablet (e.g. iPad) or laptop (e.g. MacBook) for women participating in the quantitative study
• Informed Consent as documented by signature (Appendix Informed Consent Form)

You may not qualify if:

• Patients being judged by a physician or by a gynaecology-oncology nurse specialist as not being capable to participate in the trial and to complete the questionnaire due to:
• Cognitive, linguistic, emotional or physical reasons
• A present psychiatric treatment by reason of a main psychiatric diagnosis and the intake of psychopharmacological drugs
• Terminal illness

Sponsors & Collaborators

• St.Gallen University of Applied Sciences: lead
• Cantonal Hospital of St. Gallen: collaborator
• Cantonal Hospital of Lucerne: collaborator
• Regional Hospital of Lugano: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (4)

Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

Regional Hospital of Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

University Hospital of Bern

Bern, 3000, Switzerland

Location

Cantonal Hospital of Lucerne

Lucerne, 6000, Switzerland

Location

Related Publications (28)

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Related Links

• Royal College of Obstetricians and Gynaecologists. (2014). Guideline for Diagnosis and Management of Vulval Carcinoma.
• Swiss Confederation. (2014). Federal Law on Data Protection.

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers and the statistician will be blinded to treatment assignment to prevent ascertainment bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: September 9, 2020
• Study Start: May 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)