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Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology (LETSGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453788
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
University of Agder
Uppsala University
Information provided by (Responsible Party):
Sorlandet Hospital HF

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Device: LETSGO app Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective cohort study with reference group.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology: Pilot Study
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: LETSGO app
LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up
No Intervention: Reference group
Regular hospital follow-up.The patients will fill in an electronic questionnaire package at baseline, 3, and 6 months after treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Satisfaction with LETSGOapp [ Time Frame: 8 months ]
    Evaluate satisfaction with app through patient interviews


Secondary Outcome Measures :
  1. Recruitment rate [ Time Frame: 6 months ]
    Evaluate the patient recruitment rate

  2. Acceptability of goal setting [ Time Frame: 8 months ]
    Evaluate acceptability of goalsetting through changes in Activity level


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453788


Locations
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Norway
Sorlandet Hospital
Kristiansand, Vest Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
University of Agder
Uppsala University
Investigators
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Study Chair: Frode Gallefoss Chief of Research Department, Sørlandet Hospital
More Information
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Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT03453788    
Other Study ID Numbers: LETSGOpilot
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a pilot study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorlandet Hospital HF:
follow up
side effects
smartphone app
 physical activity
empowerment
patient reported outcomes