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The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study (LETSGO)

S

Sorlandet Hospital HF

Status

Active, not recruiting

Conditions

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

Treatments

Other: LETSGO follow-up

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

754 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

754 participants in 2 patient groups

Intervention arm
Experimental group
Description:
New follow-up model
Treatment:
Other: LETSGO follow-up
Control arm
No Intervention group
Description:
Usual care

Trial contacts and locations

12

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Central trial contact

Ingvild Vistad, MD, PhD; Sveinung Berntsen, MD. PhD

Data sourced from clinicaltrials.gov

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