NCT04541784 — Effectiveness of an App Intervention to Reduce Postsurgical Symptom Distress in Patients With Vulvar Neoplasia · CancerIndex
Clinical trial · Interventional
Effectiveness of an App Intervention to Reduce Postsurgical Symptom Distress in Patients With Vulvar Neoplasia
Effectiveness of a Multidimensional Mobile App Intervention "WOMAN-PRO III" to Reduce Postsurgical Symptom Induced Distress in Patients With Vulvar Neoplasia: A Mixed Methods Project
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Three counselling sessions with gynaecology-oncology nurses
Other
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UNRESOLVED
WOMAN-PRO III
Other
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UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
ACTIVE_COMPARATOR
label
3 counselling sessions with gynaecology-oncology nurses
description
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.
interventionNames
Other: Three counselling sessions with gynaecology-oncology nurses
type
EXPERIMENTAL
label
Mobile app and 3 counselling sessions (WOMAN-PROIII)
description
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.
interventionNames
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
References
Publications (28)
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Other: WOMAN-PRO III
Primary outcomes (1)
measure
Change of symptom induced distress
timeFrame
Between diagnosis / before surgical treatment (t0), day seven post-surgery (t1) and month six post-surgery (t2)
description
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).
Secondary outcomes (2)
measure
Uncertainty
timeFrame
Between diagnosis / before surgical treatment (t0), day seven post-surgery (t1) and month six post-surgery (t2)
description
Measured with the Mishel Uncertainty in Illness Scale (MUIS). The MUIS is a 30-item scale assessing uncertainty in symptomatology, diagnosis, treatment, relationship with care-givers and planning for the future for patients with cancer. Internal consistency showed a multi-attributed ambiguity alpha ranging from 0.89-0.91 and an unpredictability alpha from 0.64-0.72. Scale development based on theoretical framework of cognitive appraisal model and perceived uncertainty in illness model as well as interviews with patients and health provider review. Factors were identified by factor analysis and confirmed by replication out of sample (Mishel, 1981).
measure
Cost effectiveness
timeFrame
During a period of 6 months after diagnosis/surgery
description
Measured by means of a within-trial analysis, comparing direct costs and six-month outcomes of patients randomized to the intervention versus control group. The economic evaluation will consist of a cost-effectiveness analysis (CEA) which includes treatment expenses (intervention costs) and the identified differences in symptom distress.
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BACKGROUNDKobleder 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 27865255
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BACKGROUNDRaphaelis S, Mayer H, Ott S, Mueller MD, Steiner E, Joura E, Senn B. The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study. Gynecol Oncol. 2017 Jul;146(1):114-122. doi: 10.1016/j.ygyno.2017.04.024. Epub 2017 May 5. PMID 28483270
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