NCT04122235

The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study

Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: Sorlandet Hospital HF · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares traditional follow-up of gynaecological cancer patients to an alternative follow-up model. In the alternative follow-up model the patients will meet a nurse at every second consultation. The nurse will focus on psychosocial health and educate the patients in the use of a study specific smartphone-application.

Detailed description

The goal is to improve follow-up of past and present cancer patients to have the best quality of life possible, despite having a serious illness. Todays' survivors differ from the survival population for whom the traditional follow-up was designed. Improvements in treatment assure that many cancer patients survive longer after diagnosis often with age-related comorbidities. Consequently, new evidence-based models for follow-up after cancer treatment with focus on techniques to improve coping with and management of late effects without increasing the costs are warranted. The chronic care model, which uses self-management interventions, is used for many chronic diseases-such as diabetes and asthma and is a valid model to consider for cancer follow-up care(1). Another relevant model is the risk stratified model where patients are stratified into low, moderate, or high-risk on the basis of expected recurrence rate and late-effects(2). Gynecological cancer patients constitute an underrepresented group in clinical cancer research. The research group has developed a follow-up model based on the principles of the risk-stratified model and the chronic care model with one or three year's hospital follow-up for low- versus medium/high-risk patients. Physicians will be replaced by nurses in 50% of the consultations. The nurses will use evidence-based behavior change techniques to coach the cancer patients on how to take an active role in management of their physical and mental late effects. These techniques will be further reinforced with a multifunctional smart phone-application (app). The "Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology-app" (LETSGO-app) has three main functions: 1) Self-evaluated symptoms (on recurrence or late effects) regularly reported through the app; 2) Targeted information on treatment, signs of recurrence, and late-effects on each cancer type and 3) Facilitation of early rehabilitation through physical activity instructions, goal-setting and electronic reminders. The investigators will conduct a multicenter study including 754 cancer survivors in Norway. Ten Norwegian hospitals will participate whereof five hospitals are intervention hospitals and five are control hospitals.

Conditions

• Gynecologic Cancer
• Gynecologic Neoplasm
• Ovarian Cancer
• Endometrial Cancer
• Cervical Cancer
• Vulvar Cancer

Interventions

Type	Name	Description
OTHER	LETSGO follow-up	Nurse-led follow-up in 50% of the consultations Access to the LETSGO-app

Timeline

• Start date: 2019-11-18
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2019-10-10
• Last updated: 2026-03-30

Locations

12 sites across 1 country: Norway