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CompletedNCT03453788LETSGOUpdated Sep 12, 2019

Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

An interventional study of LETSGO app in Gynecologic Cancer, sponsored by Sorlandet Hospital HF. Completed at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Primary conditionEmpowermentRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Empowerment
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's title name Empowerment.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sorlandet Hospital HF · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Gynecologic Cancer

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Keywords

  • follow up
  • side effects
  • smartphone app
  • physical activity
  • empowerment
  • patient reported outcomes
03

In context

Empowerment Reclassified

154 studies on the registry are indexed under Empowerment; 31 are open to participants now.

This study's enrollment of 24 is below the median of 141 across 132 interventional studies indexed under Empowerment.

Browse Empowerment studies →

Lead sponsor

Sorlandet Hospital HF is the lead sponsor of 74 studies on the registry; 12 are open to participants now.

Compared within Empowerment, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • \< 18 years
  • Not able to read Norwegian
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

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.

    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.

Interventions

  • DeviceLETSGO app

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

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What researchers measure

Primary outcomes

  1. Satisfaction with LETSGOapp

    Evaluate satisfaction with app through patient interviews

    Time frame: 8 months

Secondary outcomes

  1. Recruitment rate

    Evaluate the patient recruitment rate

    Time frame: 6 months

  2. Acceptability of goal setting

    Evaluate acceptability of goalsetting through changes in Activity level

    Time frame: 8 months

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Study locations

1 site
  • Sorlandet Hospital
    Kristiansand, Vest Agder 4604, Norway
08

References and documents

Individual participant data

Plan to share: No — This is a pilot study

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in May 2019, 14 months.

Of 82 non-industry interventional studies with no phase under Empowerment, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 14 months is below that.

Counting every sponsor, half of 82 studies reached it within 22 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2018
First posted
Mar 5, 2018
StartActual
Mar 20, 2018
Primary completionActual
May 31, 2019
CompletionActual
May 31, 2019
Last update
Sep 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03453788
Lead sponsor
Sorlandet Hospital HF
Collaborators
University of Agder, Uppsala University
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Mar 20, 2018
Primary completion
May 31, 2019
Completion
May 31, 2019
Last update
Sep 12, 2019

Study contacts

Frode Gallefoss
study chair · Chief of Research Department, Sørlandet Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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