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

• ClinicalTrials.gov Identifier: NCT04122235
• Recruitment Status: Recruiting
• First Posted: October 10, 2019
• Last Update Posted: October 23, 2020
• Sponsor: Sorlandet Hospital HF
• Collaborators: University of Agder; Uppsala University
• Information provided by (Responsible Party): Ingvild Vistad, Sorlandet Hospital HF

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gynecologic Cancer; Gynecologic Neoplasm; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Vulvar Cancer	Other: LETSGO follow-up	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 754 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
• Actual Study Start Date: November 18, 2019
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2030

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention arm; New follow-up model	Other: LETSGO follow-up; Nurse-led follow-up in 50% of the consultations Access to the LETSGO-app
No Intervention: Control arm; Usual care

Outcome Measures

Primary Outcome Measures :

1. Patients' score on the Health Education Impact Questionnaire (HEI-Q) [ Time Frame: Assessed right after initial treatment, and 3, 6, 12, 24 and 36 months after treatment ]
   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.

Secondary Outcome Measures :

1. 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) [ Time Frame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively ]
   The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. For the raw score, lower scored are considered a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. Firstly, raw score has to be calculated with mean values. Afterwards linear transformation is performed Higher transformed scores are considered a better outcome. We will analyze change in Global Health Status and other subscales of the C30 questionnaire from end of treatment to 12, 24 and 36 months, respectively.
2. Change adherence to physical activity recommendations [ Time Frame: Change from baseline to 12, 24 and 36 months after completion of primary treatment ]
   Physical activity level recorded objectively with an activity monitor. Daily steps recorded by the activity device will be averaged over the time periods between patient visits, with days of zero daily steps excluded from the average. The data will be recoded into 10-min epochs of moderate-to-vigorous physical activity.
3. Physical activity goals [ Time Frame: Change from baseline to 12, 24 and 36 months after completion of primary treatment ]
   The investigators have developed an app where the participants may choose activity goals. Number and type of goals will be reported with descriptive statistics.
4. Changes in physical activity level based on International Physical Activity Questionnaire - Short Form (IPAQ) [ Time Frame: Change from baseline to 12, 24 and 36 months after completion of primary treatment ]
   Physical activity level will be measured using the short-form of the International Physical Activity Questionnaire (IPAQ). The measure uses open-ended questions covering an individual's last 7-day recall of physical activity. There are no subscales. IPAQ-SF quantifies physical activity during the last seven days divided into four categories: vigorous intensity, moderate intensity, walking and sitting. In addition to intensity, frequency and duration of physical activity are assessed. Using the instrument's scoring protocol, weekly physical activity will be estimated by weighting time spent in each activity intensity with its estimated metabolic equivalent (MET) energy expenditure. The scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively.
5. Patients' score on the Health Education Impact Questionnaire (HEI-Q) [ Time Frame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively ]
   Evaluating 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. Each domain is assessed separately and the scores are reported as the overall mean for each domain. We intend to assess change in the remaining subscales of the HEI-Q from end of treatment to 12, 24 and 36 months after treatment in addition to the primary outcome subscale.
6. Costs-effectiveness using the EuroQol 5-Dimensional (EQ5D) [ Time Frame: Change from end of treatment (baseline) to 36 months after completion of primary treatment ]
   Cost-effectiveness from the health care perspective using the EuroQol five-Dimensional (EQ5D) measure. EQ5D measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale ranging from 0-100). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention. Crude differences between groups will be assessed.
7. Frequency of health care use [ Time Frame: Change from baseline to 36 months after completion of primary treatment ]
   Frequency of health care use will be obtained through registries on health care services
8. Time to recurrence [ Time Frame: Compare findings between intervention group and control group at 36 months after completion of primary treatment ]
   In this study we will compare proportions of women who experienced their first recurrence in both groups, and for those who had a recurrence, compare the times from inclusion to the first recurrence assessed at 36 months after the end of primary treatment
9. Time to recurrence [ Time Frame: Differences between intervention group and control group at 60 months after completion of primary treatment ]
   In this study we will compare proportions of women who experienced their first recurrence in both groups, and for those who had a recurrence, compare the times from inclusion to the first recurrence assessed at 60 months after the end of primary treatment
10. Survival [ Time Frame: Differences between intervention group and control group at 60 months after completion of primary treatment ]
    In this study we will describe cause specific survival and overall survival defined as time from the inclusion to death or end of follow up (whichever comes first) and compare crude survival between the intervention group and control group. The end of follow up is set at 60 months after completion of primary treatment.
11. Differences in expression of biomarkers in cancer tissue in relation to recurrence of disease [ Time Frame: Compare differences between patients with and without recurrence at 36 months after completion of primary treatment ]
    Biomarker expression including CXCR4, SMAD4, SOX9 and IFIT3 in cancer tissue will be assessed by immunohistochemistry and verified by PCR from tumor
12. Impact of physical activity changes on inflammatory biomarkers in blood [ Time Frame: Change from baseline to 36 months after completion of primary treatment ]
    Change in inflammatory biomarkers including PGE2, TNF alpha, IL1 beta, IL-8 and IL-10 will be assessed in blood samples. Differences in concentrations between the two study groups will be assessed by enzyme-linked immunosorbent assay and multiplex bead assays.
13. Impact of physical activity changes on insulin biomarkers in blood [ Time Frame: Change from baseline to 36 months after completion of primary treatment ]
    Change in the insulin pathway including adiponectin, leptin, insulin, IGF1, and IGFBP3 will be assessed in blood samples. Differences in concentrations between the two study groups will be assessed by immunoassays.
14. Examination of Circulating tumor DNA (ctDNA) at the point of disease progression compared with 3 months values [ Time Frame: At 3 months and at progression ]
    Analyze of absolute quantities of ctDNA molecules presenting in blood at 3 months and at progression
15. Changes in the use of a study specific smartphone application [ Time Frame: 36 months after completion of primary treatment ]
    We will explore how frequent different parts of the app are used. Which elements of the app and frequency of use will be reported with descriptive statistics.
16. 4.Cancer type specific quality of life using the EORTC Endometrial Cancer Module (EORTC QLQ-EN24) [ Time Frame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively ]
    EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in patients with all stages of endometrial cancer, and consists of 24 questions including multi-item scales and single item measures. These include three functional scales (sexual interest, activity, and enjoyment), five symptom scales (lymphoedema, urological symptoms, GI symptoms, poor body image, and sexual/vaginal problems), and five single items (back/pelvis pain, tingling/numbness, muscular pain, hair loss, and taste change). Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. Change from baseline to 6, 12, 24 and 36 months respectively.
17. 4.Cancer type specific quality of life using the EORTC Ovarian Cancer Module (EORTC QLQ-OV28) [ Time Frame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively ]
    EORTC QLQ-OV28 is a validated questionnaire to assess the overall health-related quality of life in patients with all stages of ovarian cancer, and consists of 28 questions including multi-item scales and single item measures. The module covers abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. Change from baseline to 6, 12, 24 and 36 months respectively.
18. 4.Cancer type specific quality of life using the EORTC Cervical Cancer Module (EORTC QLQ-CX24) [ Time Frame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively ]
    EORTC QLQ-CX24 is a validated questionnaire to assess the overall health-related quality of life in patients with all stages of cervical cancer, and consists of 24 questions including multi-item scales and single item measures. The EORTC QLQ-CX24 can be summarized in three multi-item scales, namely, symptom experience (eleven items), body image (three items), and sexual/vaginal functioning (four items). The other dimensions of the questionnaire are single-item scales, covering lymphedema, peripheral neuropathy, menopausal symptoms, sexual worry, sexual activity, and sexual enjoy. Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. Change from baseline to 6, 12, 24 and 36 months respectively.
19. 4.Cancer type specific quality of life using the EORTC Vulvar Cancer Module (EORTC QLQ-VU34) [ Time Frame: Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively ]
    EORTC QLQ-VU34 is a questionnaire to assess the overall health-related quality of life in patients with all stages of vulvar cancer, and consists of 34 questions including multi-item scales and single item measures. The module covers abdominal/gastrointestinal symptoms, vaginal and inguinal problems, other treatment related side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. Change from baseline to 6, 12, 24 and 36 months respectively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Gynecological cancer
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Norway

Sorlandet Hospital; Recruiting

Kristiansand, Vest Agder, Norway, 4604

Contact: Ingvild R Vistad, MD, PhD 47-380 73000 ext 8482 ingvild.vistad@sshf.no

Contact: Mette Skorstad, MD 47-380 73000 mette.skorstad@sshf.no

Principal Investigator: Ingvild Vistad, MD, PhD

Sørlandet hospital Arendal; Recruiting

Arendal, Norway

Contact: Astrid Liavaag, MD PhD 4797702378 astrid.liavaag@sshf.no

Nordland Hospital; Recruiting

Bodø, Norway

Contact: Stine Andreassen, MD PhD 4775512900 Stine.Andreasen@nordlandssykehuset.no

Akershus University Hospital; Recruiting

Lørenskog, Norway

Contact: Kurt Sachse, MD 4793685833 kurtsachse@yahoo.com

Contact: Ala J Haug, MD 4791885875 Ala.Jabri.Haug@ahus.no

Oslo University Hospital; Recruiting

Oslo, Norway

Contact: Kristina Lindemann, MD PhD 4748512384 klinde@ous-hf.no

Contact: Mari B Elstrand, MD PhD 4741421286 melst@ous-hf.no

Østfold Hospital Trust; Recruiting

Sarpsborg, Norway

Contact: Tea Brummer, MD PhD 4741708707 Tea.Brummer@so-hf.no

Stavanger University Hospital; Recruiting

Stavanger, Norway

Contact: Bent Fiane, MD 4741304387 bef@sus.no

Contact: Elisabeth B Nilsen, MD 4793682821 elisabeth.berge.nilsen@sus.no

University Hospital of North Norway; Recruiting

Tromsø, Norway

Contact: Anne Gry Bentzen, MD PhD 4799046460 Anne.Gry.Bentzen@unn.no

St.Olavs Hospital; Recruiting

Trondheim, Norway

Contact: Trine Stokstad, MD PhD 4790671983 Trine.Stokstad@stolav.no

Vestfold Hospital Trust; Recruiting

Tønsberg, Norway

Contact: Tonje Bohlin 4798842570 tobohlin@hotmail.com

Sponsors and Collaborators

Sorlandet Hospital HF

University of Agder

Uppsala University

More Information

• Responsible Party: Ingvild Vistad, Professor, Sorlandet Hospital HF
• ClinicalTrials.gov Identifier: NCT04122235
• Other Study ID Numbers: 813476
• First Posted: October 10, 2019
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: After ending the study and analysis of the data, data becomes available for use by those involved in the study according to internal terms

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ingvild Vistad, Sorlandet Hospital HF:

follow-up; app; lifestyle; empowerment; nurse-led

Additional relevant MeSH terms:

Endometrial Neoplasms; Vulvar Neoplasms; Genital Neoplasms, Female; Neoplasms by Site; Neoplasms; Urogenital Neoplasms; Uterine Neoplasms; Uterine Diseases; Vulvar Diseases