Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

patients will make a regular assessment of symptoms via an electronic questionnaire

patients will have the standard follow-up

The operation of Oncolaxy© is based on the principle of e-PRO (electronic patient reported outcome) which is able to assess the symptoms declared by patients treated for cancer, to detect an evolution, a recurrence or the toxicity of a therapy. Alerts are sent to the healthcare team if the algorithm detects suspicious symptoms or worsening of these symptoms.

Oncolaxy© records symptoms using an electronic questionnaire that allows them to be graded. Questionnaires are sent out on a regular basis. The algorithm analyzes the responses and processes them taking into account the score of the response and its evolution over time. The combination of the results makes it possible to send information to the healthcare teams in charge of the patient that will alert them, enlighten them and help them guide their decisions which remain under their sole control. The summary of the results can be viewed at any time on a dashboard.

ONCOLAXY Follow-up

Magali BALAVOINE

Katell LE DÛ, MD

Olivier FITOUSSI, MD

Marielle LE GOFF, MD

Elsa LESTANG, MD

Frédéric MALOISEL, MD

Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.

Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment

The events will be collected (CTCAE V5.0) per patient

The period of management of event will be evaluated between the date of the event and the first action realize to manage this event (patient contact, consultation, hospitalization, prescription, etc.) incremented in the source file

The number of emergency visits (consultation or hospitalization in the suites) per arm

The number and average length of stay of hospitalizations per patient and per arm

The dose of treatment received compared to the theoretical dose will assess the dose / intensity

The number of patients having had a treatment interruption will be recorded out of the total number of patients

Quality of life will be evaluated by the Quality of Life Questionnaire-C30 (QLQ-C30). QLQ-C30 is a generic questionnaire for cancer patients. Score will be calculated according to EORTC guidelines. The scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. QoL with QLQ-C30 will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months. Score will be calculated according to EORTC guidelines

Anxiety will be evaluated by the State-Trait Anxiety Inventory Form Y (STAI-Y scale). STAI-Y is a specific questionnaire for which reflects the current emotional state (STAI-form Y-A) which makes it possible to assess the nervousness and anxiety of the patient. The scores range from 20 to 80; Higher score is worse.

STAI-Y will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months.

Patient satisfaction will be evaluated by a specific self-evaluation (specific questionnaire dedicated to the use of the web-application) at the end of treatment, 12th and 24th months follow-up visits. The scores range from 14 to 70; Higher score is better.

Overall survival will be calculated from the date of randomization to the date of death due to any cause or the date last known to be alive if patient is censored

Progression Free survival will be calculated from the date of randomization to the date of first progression of disease based on Investigator assessment per Lugano classification or the date of death or censored at the date of the last valid tumor assessment

Event-free survival will be defined as the time between the date of treatment initiation and the date of the first event (relapse, death, unplanned hospitalizations) demonstrated or the date of death if the patient died or the date of the last news if the patient is censored,

Health care team satisfaction will be evaluated by a specific questionnaire (specific questionnaire dedicated to the use of the web-application) at the 6th and 12th of use of application. The scores range from 8 to 33; Higher score is worse.

In the application arm the number of face-to-face consultations triggered by an alert

In the application arm the number of teleconsultations triggered by an alert

In the application arm the number of drug prescription triggered by an alert

In the application arm the number of nursing prescription triggered by an alert

Resilience Care

Incyte Corporation

Weprom

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

Participants will have available the services offered by the Women's Cancer Survivorship Clinic and will undertake electronic Patient Reported Outcomes at baseline, 2, 4, 6, 8, 10, 12 months (end of the study).

Participants will attend a baseline and end of the study visit (12-month time point) to the Women's Cancer Survivorship Clinic to undertake the baseline and complete end of study assessments. They will complete ePRO at baseline and at 12 months. They will have usual follow up care over the 12 month period of the study. Where participants in the control arm contact the Survivorship team for clinical or other advice, they will be referred to the usual care pathway.

Patients will visit in person the Survivorship Clinic at the baseline and end of the study (12-month) at the ORCHID center in the Cork University Hospital (Cork, Ireland).

During these visits, baseline and end of the study assessments will be made. Patients will receive routine standard information, a care plan and resources about survivorship at the baseline visit.

Survivorship Clinic Assessments

Patients will receive a Survivorship Personal Treatment Plan by the nurse from the Women's Health Initiative Survivorship Clinic according to the results from the baseline ePROs. In addition to that, each 2 months for a period of 12 months, the patient will be answering ePROs. The nurse will undertake an intervention when needed based as per the Trigger system (developed form ePROs responses) or clinical judgement.

- ePRO Symptom Survey Instrument (nurse questions): A core list of symptoms/adverse events that are identified including gastrointestinal, attention/memory, pain, fatigue and insomnia, mood-emotional distress/depression, anxiety, fear of cancer recurrence, gynaecological, urinary, sexual issues, hot flashes.

Survivorship Clinic Nurse Resource

Patients will receive Diet Education and Personalised Nutrition Counselling by the dietitian from the Women's Health Initiative Survivorship Clinic at the baseline. In addition to that, each 2 months for a period of 12 months, the patient will be answering ePROs. The dietitian will undertake an intervention when needed as per the Trigger system (developed form ePROs responses) or clinical judgement.

- ePRO Symptom Survey Instrument (diet questions): nutritional risk (lack of appetite; worry regarding weight loss; worry regarding weight gain), weight, and exercise.

Survivorship Clinic Dietitian Resource

Kate O Connell, Ms.

Laia Raigal, Dr.

This study's aim is to evaluate the feasibility of introducing a women's malignancy survivorship clinic incorporating symptom management through ePRO collection (complex intervention) into routine follow up care in patients with early-stage Hormone Receptor(HR)-positive breast and gynaecologic cancer post primary curative therapy.

Study Design: Complex interventional study. Specific Aims: To evaluate the feasibility of introducing a women's malignancy survivorship clinic in Ireland incorporating symptom management through electronic Patient Reported Outcomes (ePROs) collection (complex intervention) into routine follow-up care in patients with early-stage HR-positive breast and gynecologic cancer post-primary therapy.

Sampling Method: Randomized Control Design (Parallel Arms). Sample Size: 200.

Entry Criteria: Women with early-stage breast/gynecologic cancer within 12 months of completion of primary curative therapy:

* Breast cancer: Stage I-III hormone receptor-positive (defined as estrogen receptor and/or progesterone receptor ≥ 1%) and HER2-negative per ASCO-CAP guidelines on or recommended to commence adjuvant endocrine therapy during the study period.
* Cervical cancer: Stage I to III treated with curative intent.
* Endometrial cancer: treated with curative intent adjuvant radiotherapy +/- chemotherapy

The LYSA (Linking You to Support and Advice) Trial

Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial

Number of patients who were eligible and accepted to participate in the study. This will be recorded in the electronic Case Report Forms (eCRF).

The reasons for not enrolling will be asked to the patient considering and clusters of option groups will be done.This will be recorded in the electronic Case Report Forms (eCRF).

Patients will be contacted to ask about the reasons for not completing the intervention. This will be recorded in the electronic Case Report Forms (eCRF).

Number of enrolled patients who complete the baseline and follow-up ePRO surveys. This will be recorded in the ePROs.

A trigger system with the ePRO measurements has been developed to assess symptoms deterioration that will require that the nurse or Dietitian contact the patient. This will be recorded in the electronic Case Report Forms (eCRF).

Time spent by the Nurse, the Dietitian and other Health Care Professionals (HCP) from the Women Survivorship Clinic during consultation will be collected. This will be recorded in the electronic Case Report Forms (eCRF).

The cancer-related symptoms items will be assessed by the validated Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) item library and Patient-Reported Outcomes Measurement Information System (PROMIS) item library.

All patients will answer at the baseline and at the end of the intervention EORTC QLQ-C30 (30 items). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.

Cohort of patients who had breast cancer will answer at the baseline and at the end of the intervention EORTC QLQ Breast Cancer Module (BR23). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.

Cohort of patients who had cervical cancer will answer at the baseline and at the end of the intervention EORTC QLQ Cervical Cancer Module (CX24). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.

Cohort of patients who had endometrial cancer will answer at the baseline and at the end of the intervention EORTC QLQ Endometrial Cancer Module (EN24). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.

All patients will answer the EQ-5D-5L-QALY at the baseline and at the end of the intervention. A high score represents high functionality problems.

All patients will answer at the baseline and at the end of the intervention the Appraisal Self-Care Agency-R (15 items). The higher the score, the better the self-care agency

All patients will self-report their adherence at the baseline and at the end of the study. The intervention arm will be asked about it every 2 months.

Patients in the intervention arm will complete the Usability and Satisfaction Scale (Lewis, 1995) at the end of the intervention. The higher the score, the better usability and satisfaction from the participant.

Qualitative data collection will be done via Interviews/Focus Groups at the end of the intervention.

The main sources from which this data will be collected include: patient hospital record forms, case report forms, use of resources forms, and patient diaries.

All patients will answer at the baseline and at the end of the intervention the FFQ. All patients will answer at the baseline and at the end of the intervention the Food Frequency Questionnaire. Data will be entered in to the FFQ European Prospective Investigation into Cancer and Nutrition (EPIC) Tool for Analysis (FETA). FETA calculates the average daily intake of 46 nutrients and 14 food groups, for each individual. The default nutrients list provides a description of each nutrient/food group and the units used. The nutrient data for the FFQ foods have come from McCance and Widdowson's "The Composition of Foods (5th edition)" and its associated supplements.

All patients will answer at the baseline and at the end of the intervention the WCRF/AICR. The higher the score, the better Diet quality.

The dietitian will perform physical assessments of each patient at the baseline and at the end of the study. Weight and height will be combined to report BMI in kg/m\^2. Patients in the intervention arm will self-report weight in kg every 2 months.

The dietitian will perform physical assessments of each patient at the baseline and at the end of the study. Weight and body fat will be combined to report LBM in kg\*(Percentage body/100).

The dietitian will perform physical assessments of each patient at the baseline and at the end of the study. Waist circumference will be measured in cm.

The dietitian will perform physical assessments on each patient at the baseline and at the end of the study. Weight (Kg) and body fat (%) and Total Body Water (TBW) will be combined to report the Body Composition score.

The dietitian will perform physical assessments to each patient at the baseline and at the end of the study. Muscle strength will be measured using hand grip strength (HGS) based on the Jamar Dynamometer (Model 091011725).

All patients will complete the MST at the baseline and at the end of the intervention. Patients in the intervention arm answer the MST each 2 months. The higher the score, the higher risk of malnutrition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma	NCT05298293	Diffuse Large B...	ONCOLAXY Follow...	18 Years -	Weprom
The LYSA (Linking You to Support and Advice) Trial	NCT05035173	Survivorship Breast Cancer Cervical Cancer Endometrial Can...	Survivorship Cl... Survivorship Cl... Survivorship Cl...	18 Years -	University College Cork

Spots Global Cancer Trial Database for electronic patient reported outcomes