The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study
LETSGO
Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
1 other identifier
interventional
755
1 country
12
Brief Summary
This study compares traditional follow-up of gynaecological cancer patients to an alternative follow-up model. In the alternative follow-up model the patients will meet a nurse at every second consultation. The nurse will focus on psychosocial health and educate the patients in the use of a study specific smartphone-application.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2026
CompletedMarch 30, 2026
March 1, 2026
6.4 years
September 2, 2019
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients' score on the Health Education Impact Questionnaire (HEI-Q)
Evaluating the immediate effects of self-management interventions in cancer follow-up. It contains the following domains: Health-directed activities, Positive and active engagement in life, Emotional distress, Constructive attitudes and approaches, Self-monitoring and insight, Skill and technique acquisition, Social integration and support, Health service navigation. Individuals are asked to indicate their level of agreement with 42 statements across the eight domains on four-point Likert scales (1 "strongly disagree" to 4 "Strongly agree"). Higher scores indicate greater performance of specific self-management behaviors. Higher scores on the emotional well-being domain denote higher levels of negative affect. Data from each domain will be used individually and the results reported as mean domain score. The primary outcome is the change of the insight subscale scores of the HEI-Q from right after treatment (baseline) to 12 months after treatment.
Assessed right after initial treatment, and 3, 6, 12, 24 and 36 months after treatment
Secondary Outcomes (19)
Patients' score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), measuring ´Health related quality of life (HRQL)
Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
Change adherence to physical activity recommendations
Change from baseline to 12, 24 and 36 months after completion of primary treatment
Physical activity goals
Change from baseline to 12, 24 and 36 months after completion of primary treatment
Changes in physical activity level based on International Physical Activity Questionnaire - Short Form (IPAQ)
Change from baseline to 12, 24 and 36 months after completion of primary treatment
Patients' score on the Health Education Impact Questionnaire (HEI-Q)
Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
- +14 more secondary outcomes
Study Arms (2)
Intervention arm
EXPERIMENTALNew follow-up model
Control arm
NO INTERVENTIONUsual care
Interventions
Nurse-led follow-up in 50% of the consultations Access to the LETSGO-app
Eligibility Criteria
You may qualify if:
- Histologically verified gynaecological cancer
- Cervical cancer restricted to squameous cell carcinoma, adeno carcinoma and adeno-squameous carcinoma) or
- Endometrial cancer or
- Ovarian cancer (restricted to epithelial type) or
- Vulvar cancer
- Must have completed primary treatment and scheduled to follow-up
You may not qualify if:
- Participating in other cancer treatment trial or follow-up trial
- Cervical cancer patients treated with trachelectomy
- On maintenance therapy
- Dementia or other mental/cognitive impairment
- Illiterate in Norwegian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sorlandet Hospital HFlead
- University of Agdercollaborator
- Uppsala Universitycollaborator
Study Sites (12)
Innlandet Hospital Gjøvik
Gjøvik, Oppland, 2819, Norway
Sorlandet Hospital
Kristiansand, Vest Agder, 4604, Norway
Sørlandet hospital Arendal
Arendal, Norway
Nordland Hospital
Bodø, Norway
Innlandet Hospital Lillehammer
Lillehammer, 2609, Norway
Akershus University Hospital
Lørenskog, Norway
Oslo University Hospital
Oslo, Norway
Østfold Hospital Trust
Sarpsborg, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St.Olavs Hospital
Trondheim, Norway
Vestfold Hospital Trust
Tønsberg, Norway
Related Publications (1)
Vistad I, Skorstad M, Demmelmaier I, Smastuen MC, Lindemann K, Wisloff T, van de Poll-Franse LV, Berntsen S. Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking. BMJ Open. 2021 Jul 12;11(7):e050930. doi: 10.1136/bmjopen-2021-050930.
PMID: 34253678DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingvild Vistad, MD, PhD
Sorlandet Hospital HF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 2, 2019
First Posted
October 10, 2019
Study Start
November 18, 2019
Primary Completion
March 27, 2026
Study Completion
March 27, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available within one year after end of study (i.e.March 2026), and the data will be made accessible for up to 5 years. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
At the end of the study, data will be made available (after anonymisation) upon request to the corresponding author. The data collected will be stored for up to 15 years after the end of study. This timeperiod will take into account possible national and international legal restrictions (ie, Norwegian and EU regulations).