The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study

NCT ID: NCT04122235

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 754 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2030-12-31

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.

Detailed Description

The goal is to improve follow-up of past and present cancer patients to have the best quality of life possible, despite having a serious illness. Todays' survivors differ from the survival population for whom the traditional follow-up was designed. Improvements in treatment assure that many cancer patients survive longer after diagnosis often with age-related comorbidities. Consequently, new evidence-based models for follow-up after cancer treatment with focus on techniques to improve coping with and management of late effects without increasing the costs are warranted. The chronic care model, which uses self-management interventions, is used for many chronic diseases-such as diabetes and asthma and is a valid model to consider for cancer follow-up care(1). Another relevant model is the risk stratified model where patients are stratified into low, moderate, or high-risk on the basis of expected recurrence rate and late-effects(2). Gynecological cancer patients constitute an underrepresented group in clinical cancer research.

The research group has developed a follow-up model based on the principles of the risk-stratified model and the chronic care model with one or three year's hospital follow-up for low- versus medium/high-risk patients. Physicians will be replaced by nurses in 50% of the consultations. The nurses will use evidence-based behavior change techniques to coach the cancer patients on how to take an active role in management of their physical and mental late effects. These techniques will be further reinforced with a multifunctional smart phone-application (app). The "Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology-app" (LETSGO-app) has three main functions: 1) Self-evaluated symptoms (on recurrence or late effects) regularly reported through the app; 2) Targeted information on treatment, signs of recurrence, and late-effects on each cancer type and 3) Facilitation of early rehabilitation through physical activity instructions, goal-setting and electronic reminders.

The investigators will conduct a multicenter study including 754 cancer survivors in Norway. Ten Norwegian hospitals will participate whereof five hospitals are intervention hospitals and five are control hospitals.

Conditions

Gynecologic Cancer; Gynecologic Neoplasm; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Vulvar Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention arm

New follow-up model

Group Type: EXPERIMENTAL

LETSGO follow-up

Intervention Type: OTHER

Nurse-led follow-up in 50% of the consultations Access to the LETSGO-app

Control arm

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LETSGO follow-up

Nurse-led follow-up in 50% of the consultations Access to the LETSGO-app

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Agder

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ingvild Vistad

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingvild Vistad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sorlandet Hospital HF

Locations

Innlandet Hospital Gjøvik

Gjøvik, Oppland, Norway

Sorlandet Hospital

Kristiansand, Vest Agder, Norway

Sørlandet hospital Arendal

Arendal, , Norway

Nordland Hospital

Bodø, , Norway

Innlandet Hospital Lillehammer

Lillehammer, , 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

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 34253678 (View on PubMed)

Other Identifiers

813476

Identifier Type: -

Identifier Source: org_study_id