Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

NCT ID: NCT03453788

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2019-05-31

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.

Conditions

Gynecologic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

LETSGO app

Intervention Type: DEVICE

LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up

Reference group

Regular hospital follow-up.The patients will fill in an electronic questionnaire package at baseline, 3, and 6 months after treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LETSGO app

LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Agder

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frode Gallefoss

Role: STUDY_CHAIR

Chief of Research Department, Sørlandet Hospital

Locations

Sorlandet Hospital

Kristiansand, Vest Agder, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 36434602 (View on PubMed)

Other Identifiers

LETSGOpilot

Identifier Type: -

Identifier Source: org_study_id