The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study

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Brief Title

The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study

Official Title

Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

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.
    


Study Type

Interventional


Primary Outcome

Patients' score on the Health Education Impact Questionnaire (HEI-Q)

Secondary Outcome

 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)

Condition

Gynecologic Cancer

Intervention

LETSGO follow-up

Study Arms / Comparison Groups

 Intervention arm
Description:  New follow-up model

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

754

Start Date

November 18, 2019

Completion Date

December 31, 2030

Primary Completion Date

December 31, 2024

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT04122235

Organization ID

813476


Responsible Party

Principal Investigator

Study Sponsor

Sorlandet Hospital HF

Collaborators

 University of Agder

Study Sponsor

, , 


Verification Date

October 2020