Clinical trial NCT04122235: The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study
Official title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Gynecologic Neoplasm
Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Vulvar Cancer
Keywords: follow-up
app
lifestyle
empowerment
nurse-led
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Agder
name: Uppsala University
First posted: 2019-10-10
Enrollment: 754
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter controlled clinical trial of individualized nurse/physician-led follow-up (treatment group) versus standard care (control group) in approximately 754 women treated for gynecological cancer
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
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
Secondary outcomes:
measure: 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)
timeFrame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
measure: Change adherence to physical activity recommendations
timeFrame: Change from baseline to 12, 24 and 36 months after completion of primary treatment
measure: Physical activity goals
timeFrame: Change from baseline to 12, 24 and 36 months after completion of primary treatment
measure: Changes in physical activity level based on International Physical Activity Questionnaire - Short Form (IPAQ)
timeFrame: Change from baseline to 12, 24 and 36 months after completion of primary treatment
measure: Patients' score on the Health Education Impact Questionnaire (HEI-Q)
timeFrame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
measure: Costs-effectiveness using the EuroQol 5-Dimensional (EQ5D)
timeFrame: Change from end of treatment (baseline) to 36 months after completion of primary treatment
measure: Frequency of health care use
timeFrame: Change from baseline to 36 months after completion of primary treatment
measure: Time to recurrence
timeFrame: Compare findings between intervention group and control group at 36 months after completion of primary treatment
measure: Time to recurrence
timeFrame: Differences between intervention group and control group at 60 months after completion of primary treatment
measure: Survival
timeFrame: Differences between intervention group and control group at 60 months after completion of primary treatment
measure: Differences in expression of biomarkers in cancer tissue in relation to recurrence of disease
timeFrame: Compare differences between patients with and without recurrence at 36 months after completion of primary treatment
measure: Impact of physical activity changes on inflammatory biomarkers in blood
timeFrame: Change from baseline to 36 months after completion of primary treatment
measure: Impact of physical activity changes on insulin biomarkers in blood
timeFrame: Change from baseline to 36 months after completion of primary treatment
measure: Examination of Circulating tumor DNA (ctDNA) at the point of disease progression compared with 3 months values
timeFrame: At 3 months and at progression
measure: Changes in the use of a study specific smartphone application
timeFrame: 36 months after completion of primary treatment
measure: 4.Cancer type specific quality of life using the EORTC Endometrial Cancer Module (EORTC QLQ-EN24)
timeFrame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
measure: 4.Cancer type specific quality of life using the EORTC Ovarian Cancer Module (EORTC QLQ-OV28)
timeFrame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
measure: 4.Cancer type specific quality of life using the EORTC Cervical Cancer Module (EORTC QLQ-CX24)
timeFrame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
measure: 4.Cancer type specific quality of life using the EORTC Vulvar Cancer Module (EORTC QLQ-VU34)
timeFrame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively
Other outcomes:
Locations:
city: Gjøvik
country: Norway
facility: Innlandet Hospital Gjøvik
state: Oppland
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
state: Vest Agder
city: Arendal
country: Norway
facility: Sørlandet hospital Arendal
city: Bodø
country: Norway
facility: Nordland Hospital
city: Lillehammer
country: Norway
facility: Innlandet Hospital Lillehammer
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St.Olavs Hospital
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
affiliation: Sorlandet Hospital HF
name: Ingvild Vistad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.