The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study

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.

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.

The investigators have developed an app where the participants may choose activity goals. Number and type of goals will be reported with descriptive statistics.

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.

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.

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.

Frequency of health care use will be obtained through registries on health care services

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

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

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.

Biomarker expression including CXCR4, SMAD4, SOX9 and IFIT3 in cancer tissue will be assessed by immunohistochemistry and verified by PCR from tumor

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.

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.

Analyze of absolute quantities of ctDNA molecules presenting in blood at 3 months and at progression

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.

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.

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.

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.

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.