Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

Not Applicable

Completed

• Conditions: Gynecologic Cancer
• Interventions: Device: LETSGO app

• Registration Number: NCT03453788
• Lead Sponsor: Sorlandet Hospital HF

Brief Summary

This pilot study is evaluating a new smartphone application named the LETSGO app. The LETSGO app is designed to promote empowerment in patients after treatment for gynecological cancer.

Detailed Description

Gynecological cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. Many gynecological cancer survivors may experience late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle may increase empowerment and may positively influence well-being after cancer treatment. Through the LETSGO smartphone app, women treated for gynecological cancer will get access to individualized posttreatment information on side effects as well as tailored physical activity advices in order to assume more responsibility for achieving the best outcomes from her care. The participants will also regularly answer patient reported outcomes regarding possible recurrence though the app. As a first step the smart-phone application will be pilot-tested.

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Study Start: 2018-03-20
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Patients diagnosed and treated for gynecological cancer who will be followed up at the gynecological outpatient clinic in Kristiansand or Arendal
• No cognitive barriers.

Exclusion Criteria

• < 18 years
• Not able to read Norwegian

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	LETSGO app	Alternating follow-up visits by nurse and doctor. In the nurse-led consultations, the patients will be introduced to the smartphone LETSGOapp with access to information on cancer treatment and side effects, physical activity advice. Two-monthly assessment of 12 symptoms that may represent relapse through the app.The patients will fill in an electronic questionnaire package at baseline, 3, and 6 months after treatment.

Primary Outcome Measures

Name	Time	Method
Satisfaction with LETSGOapp	8 months	Evaluate satisfaction with app through patient interviews

Secondary Outcome Measures

Name	Time	Method
Acceptability of goal setting	8 months	Evaluate acceptability of goalsetting through changes in Activity level
Recruitment rate	6 months	Evaluate the patient recruitment rate

Trial Locations

Locations (1)

Sorlandet Hospital; 🇳🇴 Kristiansand, Vest Agder, Norway