Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

NCT03453788 — Not applicable, Completed, 24 participants, Sorlandet Hospital HF

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Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology: Pilot Study

Registry	NCT03453788, acronym LETSGO
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, supportive care
Enrollment	24 (Actual)
Sponsor	Sorlandet Hospital HF (Other gov); collaborators: University of Agder, Uppsala University
Conditions	Gynecologic Cancer
Interventions	LETSGO app (Device)
Dates	start 2018-03-20, primary completion 2019-05-31, completion 2019-05-31, first posted 2018-03-05, last updated 2019-09-12
Locations	1 site in Norway

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Experimental	Device: 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.
Reference group	No intervention		Regular hospital follow-up.The patients will fill in an electronic questionnaire package at baseline, 3, and 6 months after treatment.

LETSGO app (Device): LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up

+Outcome measures

Primary outcomes

Satisfaction with LETSGOapp [8 months]: Evaluate satisfaction with app through patient interviews

Secondary outcomes

Recruitment rate [6 months]: Evaluate the patient recruitment rate
Acceptability of goal setting [8 months]: Evaluate acceptability of goalsetting through changes in Activity level

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Sorlandet Hospital	Kristiansand, Vest Agder	Norway

+Publications

Results publication: Skorstad M, Vistad I, Fegran L, Berntsen S, Johannessen B. Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer. BMC Nurs. 2022 Nov 25;21(1):326. doi: 10.1186/s12912-022-01104-9. PMID 36434602

+Investigators

Frode Gallefoss, Study chair, Chief of Research Department, Sørlandet Hospital