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NCT Number: NCT05500391

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

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).

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Key information

Conditions

Stage I Testicular Seminoma Adenocarcinoma Adenocarcinoma, Clear Cell Aggressive Fibromatosis of Abdominal Wall (Disorder) Borderline Ovarian Tumor Carcinoma Carcinoma, Small Cell Carcinosarcoma Carcinosarcoma, Ovarian Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Germinoma Glioma Mucinous Adenocarcinoma of Ovary Neoplasms Neoplasms by Histologic Type Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Gonadal Tissue Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroendocrine Tumors Ovarian Germ Cell Tumor Sarcoma Seminoma Serous Tumor of Ovary Sex Cord-Gonadal Stromal Tumors Sex Cord-Stromal Tumor Stage I Testicular Nonseminomatous Germ Cell Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Amiens, Amiens, France

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About this study

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

  • Long-term compliance (5-year follow-up)
  • Use of care
  • Oncological events and their management
  • Supportive care needs

The exploratory objectives are to :

  • Evaluate the costs in terms of medical transportation
  • Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
  • Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
  • Evaluate the reasons for recruitment failures

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive diagnosis (anatomopathology) of tumor within 12 months
  • Patient 18 years of age or older
  • Patient with one of the following conditions:
  • Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
  • Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
  • Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
  • Operated GIST with low risk of relapse
  • Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
  • Low-grade glioma, operated
  • Low-grade neuroendocrine tumor, treated by surgery alone
  • Patient who has given consent to participate in the study

Exclusion criteria

  • Contraindication to imaging tests required for the surveillance plan
  • No telephone
  • Patient under guardianship or curatorship

Treatment and study plan

Oncological Follow-up

Other

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Primary outcomes

  1. 2-year compliance to the customized surveillance plan

    Time frame: 2 years

    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

Secondary outcomes

  1. 5-year compliance to the customized surveillance plan

    Time frame: 5 years

    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

  2. Drop-out rate

    Time frame: 5 years

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

  3. Description of the use of care

    Time frame: 5 years

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

  4. Occurrence and management of oncological events

    Time frame: 5 years

    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

  5. Progression-free survival

    Time frame: 5 years

    Time from randomization to first oncological event (progression/relapse) or death from any cause.

  6. Overall survival

    Time frame: 5 years

    Time from randomization to death from any cause

  7. Support care needs identified

    Time frame: 2 years (early termination in case of relapse of the disease)

    Support care needs include :

    • algology consultation
    • nutrition/diet consultation
    • psycho-oncology consultation
    • social worker consultation
    • job retention consultation

Other outcomes

  1. Costs in terms of medical transport use

    Time frame: 5 years

    Medical transport includes light medical vehicles and ambulances

  2. Salary mass mobilized from a hospital perspective in both arms

    Time frame: 5 years

    Salary mass mobilized from a hospital perspective in both arms

  3. Patient satisfaction

    Time frame: 2 years

    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

  4. Patient reported outcomes

    Time frame: 2 years

    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.

  5. Evaluation of the causes of recruitment failures

    Time frame: During the recruiting period (18 months)

    In each investigating site, a screening log will be completed to find out the reasons for recruitment failures

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny BEN OUNE

CONTACT

[email protected]

0320295918 ext. +33

Laurence ROTSAERT

CONTACT

[email protected]

0320295860 / 0320295918

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Canceropôle Nord Ouest
  • Groupement Interrégional de Recherche Clinique et d'Innovation

Registry information

Official study title

Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Acronym: SUR-CAN

Important dates

Study start
2024
Primary completion
2026
Study completion
2032
First posted
Aug 15, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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