Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05500391

Randomized Trial Comparing Compliance With Post-Treatment Monitoring Conducted by Hospital Physicians in Person or Nurses Remotely in Adults With Rare Tumors

Led by Centre Oscar Lambret · Updated on 2026-03-18

88

Participants Needed

3

Research Sites

300 weeks

Total Duration

On this page

Sponsors

C

Centre Oscar Lambret

Lead Sponsor

C

Canceropôle Nord Ouest

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating compliance with personalized post-treatment surveillance plans in adults recently diagnosed (within 12 months) with rare tumors. This multicenter, randomized study compares monitoring conducted in person by a hospital-based physician versus remote monitoring by a trained nurse. The study aims to understand how these two approaches affect patient adherence to follow-up care and overall management of their condition. Participants are randomly assigned to one of two groups. One group receives post-cancer surveillance, including biological, clinical, and imaging exams, conducted remotely by a nurse. The other group undergoes on-site surveillance by a hospital physician. The study includes a 2-year primary evaluation period, with extended follow-up planned for up to 5 years to assess long-term compliance, use of care, oncological events, and supportive care needs. Additional exploratory goals include evaluating transportation costs and patient satisfaction. During the study, participants will be regularly monitored according to their personalized surveillance plan, with assessments of compliance tracked over 2 and 5 years. Researchers will measure outcomes such as progression-free and overall survival, dropout rates, and psychological well-being related to anxiety and depression. The study also examines the impact of factors like gender, tumor type, occupational status, and treatment center on results. This comprehensive follow-up aims to provide detailed information on the feasibility and effects of remote versus in-person monitoring.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Positive anatomopathological diagnosis of tumor within the last 12 months
  • Patient aged 18 years or older
  • Diagnosis of one of the following: desmoid fibromatosis of the abdominal wall (operated or under active surveillance), Stage I testicular seminoma (treated or untreated with carboplatin AUC7), Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy), operated gastrointestinal stromal tumor with low risk of relapse, rare gynecological tumors (including 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) that have been operated, low-grade glioma operated, or low-grade neuroendocrine tumor treated by surgery alone
  • Patient has given consent to participate in the study
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Post-treatment Surveillance

Duration - Up to 5 years

Participants undergo personalized post-treatment monitoring, either remotely by a nurse or in person by a hospital physician, including biological, clinical, and imaging exams depending on their condition.

Regular visits as per personalized surveillance plan

Long-term Monitoring

Duration - Up to 5 years

Participants are followed for long-term compliance, clinical outcomes, and supportive care needs over a 5-year period post-treatment.

Visits according to follow-up schedule up to 5 years

Trial Site Locations

Total: 3 locations

1

CHU Amiens

Amiens, France, 80054

Not Yet Recruiting

2

Centre François Baclesse

Caen, France, 14076

Not Yet Recruiting

3

Centre Oscar Lambret

Lille, France, 59020

Actively Recruiting

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Research Team

L

Laurence ROTSAERT

F

Fanny BEN OUNE

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up.

Jayson Moloney, Carolynne Partridge, Sue Delanty...

https://pubmed.ncbi.nlm.nih.gov/31280494

Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England.

Estelle Martin, Satyendra Persaud, John Corr...

https://pubmed.ncbi.nlm.nih.gov/30093916