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

• ClinicalTrials.gov Identifier: NCT03453788
• Recruitment Status: Completed
• First Posted: March 5, 2018
• Last Update Posted: September 12, 2019
• Sponsor: Sorlandet Hospital HF
• Collaborators: University of Agder; Uppsala University
• Information provided by (Responsible Party): Sorlandet Hospital HF

Tracking Information

• First Submitted Date: February 27, 2018
• First Posted Date: March 5, 2018
• Last Update Posted Date: September 12, 2019
• Actual Study Start Date: March 20, 2018
• Actual Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2018)

Satisfaction with LETSGOapp [ Time Frame: 8 months ]

Evaluate satisfaction with app through patient interviews

Original Primary Outcome Measures (submitted: March 2, 2018)

Satisfaction with LETSGOapp [ Time Frame: 8 months ]

Evaluate satisfaction and acceptance through patient interviews

Current Secondary Outcome Measures (submitted: March 12, 2018)

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

Original Secondary Outcome Measures (submitted: March 2, 2018)

Recruitment rate [ Time Frame: 6 months ]

Evaluate the patient recruitment rate

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
• Official Title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology: Pilot Study
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective cohort study with reference group.

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Gynecologic Cancer

Intervention

Device: LETSGO app

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

Study Arms

• 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.
  Intervention: Device: LETSGO app
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2019): 24
• Original Estimated Enrollment (submitted: March 2, 2018): 30
• Actual Study Completion Date: May 31, 2019
• Actual Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT03453788
• Other Study ID Numbers: LETSGOpilot
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: This is a pilot study

• Current Responsible Party: Sorlandet Hospital HF
• Original Responsible Party: Same as current
• Current Study Sponsor: Sorlandet Hospital HF
• Original Study Sponsor: Same as current

Collaborators

• University of Agder
• Uppsala University

Investigators

• Study Chair: Frode Gallefoss; Chief of Research Department, Sørlandet Hospital

• PRS Account: Sorlandet Hospital HF
• Verification Date: September 2019