Gynecologic CancerLETSGONCT03453788
Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
A study testing LETSGO app in people with Gynecologic Cancer, run by Sorlandet Hospital HF at 1 site in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- LETSGO app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 20 Mar 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed and treated for gynecological cancer who will be followed up at the gynecological outpatient clinic in Kristiansand or Arendal
- No cognitive barriers.
Who cannot join
- < 18 years
- Not able to read Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology: Pilot Study
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.
- Conditions
- Gynecologic Cancer
- Being tested
- LETSGO app
- Keywords
- follow up, side effects, smartphone app, physical activity, empowerment, patient reported outcomes
- Medical subject headings
- Motor Activity, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LETSGO appDevice
LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: LETSGO app |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with LETSGOapp
Evaluate satisfaction with app through patient interviews
Measured: 8 months
Secondary outcomes (2)
Recruitment rate
Evaluate the patient recruitment rate
Measured: 6 months
Acceptability of goal setting
Evaluate acceptability of goalsetting through changes in Activity level
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start20 Mar 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort study with reference group.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- University of Agder, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Frode Gallefoss, Study chair, Chief of Research Department, Sørlandet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453788
- Sponsor's protocol ID
- LETSGOpilot
- Acronym
- LETSGO
- Status last verified
- Sep 2019
- First submitted
- 27 Feb 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study
Publications
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.
PubMed 36434602
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology: Pilot Study
- ClinicalTrials.gov ID
- NCT03453788
- Acronym / sponsor ID
- LETSGO / LETSGOpilot
- Conditions
- Gynecologic Cancer
- Keywords
- follow up, side effects, smartphone app, physical activity, empowerment, patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- University of Agder, Uppsala University
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cohort study with reference group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: LETSGO appAlternating 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed and treated for gynecological cancer who will be followed up at the gynecological outpatient clinic in Kristiansand or Arendal
- No cognitive barriers.
Key exclusion criteria (2 listed)
- < 18 years
- Not able to read Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LETSGO appLETSGO pilot test Group will test LETSGO app and partially nurseled follow-up | Device | Intervention group |
Primary outcome
Satisfaction with LETSGOapp
Time frame: 8 months
Evaluate satisfaction with app through patient interviews
2 secondary outcomes
Recruitment rate
Time frame: 6 months
Acceptability of goal setting
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 36434602Skorstad 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.
- Individual participant dataSharing planned: No. This is a pilot study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frode Gallefoss study chair
Chief of Research Department, Sørlandet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LETSGO app in people with Gynecologic Cancer, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with LETSGOapp (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.