Clinical trial · Interventional
The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study
Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
NCT04122235CI-TRIAL-00106760LETSGOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Neoplasm | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LETSGO follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- New follow-up model
- interventionNames
- Other: LETSGO follow-up
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Usual care
Primary outcomes (1)
- measure
- Patients' score on the Health Education Impact Questionnaire (HEI-Q)
- timeFrame
- Assessed right after initial treatment, and 3, 6, 12, 24 and 36 months after treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified gynaecological cancer 1. Cervical cancer restricted to squameous cell carcinoma, adeno carcinoma and adeno-squameous carcinoma) or 2. Endometrial cancer or 3. Ovarian cancer (restricted to epithelial type) or 4. Vulvar cancer * Must have completed primary treatment and scheduled to follow-up Exclusion Criteria: * 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
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Sindre Herskedal Fosstveit, Ingvild Vistad, Mette Skorstad et al. · JMIR Mhealth Uhealth · Aug 13, 2026 · PMID 42594257 pubmed
- DERIVEDVistad 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 34253678