Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

ConditionsStage I Testicular Seminoma Stage I Testicular Nonseminomatous Germ Cell Tumor Gastrointestinal Stromal Tumors Ovarian Germ Cell Tumor Adenocarcinoma, Clear Cell Borderline Ovarian Tumor Sex Cord-Stromal Tumor Mucinous Adenocarcinoma of Ovary Carcinoma, Small Cell Carcinosarcoma, Ovarian Serous Tumor of Ovary Glioma Neuroendocrine Tumors Aggressive Fibromatosis of Abdominal Wall (Disorder)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre Oscar Lambret

About this trial

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Positive diagnosis (anatomopathology) of tumor within 12 months

Patient 18 years of age or older

Desmoid fibromatosis of the abdominal wall operated on or under active surveillance

Stage I testicular seminoma (whether or not treated with carboplatin AUC7)

Disqualifiers

Contraindication to imaging tests required for the surveillance plan

No telephone

Patient under guardianship or curatorship

Trial design

Design model

Parallel

Treatments tested in this trial

Oncological Follow-up
Other intervention
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: ExperimentalExperimental treatment 1 intervention

Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

2-year compliance to the customized surveillance plan

Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date

Time frame

2 years

Secondary outcomes

5-year compliance to the customized surveillance plan

Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date

Time frame

5 years

Drop-out rate

Rate of patients lost to follow-up or quitting the surveillance program

Time frame

5 years

Description of the use of care

* number of physical consultations at the investigator site * number of emergency room visits for oncological reasons * number of extra-hospital consultations for oncological reasons

Time frame

5 years

Occurrence and management of oncological events

Occurence and type of oncological event : relapse/progression. The management of oncological events will be evaluated according to three criteria : * completion of an oncological surgery * implementation of a treatment by radiotherapy * implementation of a systemic therapy such as chemotherapy

Time frame

5 years

Other outcomes

Costs in terms of medical transport use

Medical transport includes light medical vehicles and ambulances

Time frame

5 years

Salary mass mobilized from a hospital perspective in both arms

Time frame

5 years

Patient satisfaction

Patients will answer a satisfaction survey (French Version of the Princess Margaret Hospital Satisfaction With Doctor) at different points of the study depending on their pathology

Time frame

2 years

Patient reported outcomes

Patient reported outcomes will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire at different points of the study depending on their pathology. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression: A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Oscar Lambret

Lead sponsor

Canceropôle Nord Ouest

Collaborator

Groupement Interrégional de Recherche Clinique et d'Innovation

Collaborator

Source ClinicalTrials.gov

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