Program to manage complications in cancer survivors after treatment

Study of Complications Related to Treatments in Adults Aged 18 to 65 Years Old Responding to a First Treatment in Oncology or Onco-hematology and Participating in the PASCA (PArcours de Santé au Cours du CAncer) Post-treatment Program.

This study is testing a program to help cancer survivors who are in remission by checking for complications from their treatment and improving their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 858 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre Leon Berard (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Lyon)
• Trial ID: NCT04671693 on ClinicalTrials.gov

What this trial studies

This study evaluates the incidence of treatment-related complications in cancer survivors who have achieved complete remission after chemotherapy. Participants will undergo a series of four assessment visits over five years to screen for 22 potential complications and identify sub-clinical abnormalities and risk factors. The program aims to provide systematic follow-up care to improve the quality of life for survivors of various cancers, including testicular germ cell tumors and non-metastatic breast carcinoma.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have completed chemotherapy for specific cancers and achieved complete remission.

Not a fit: Patients who have not undergone chemotherapy or those outside the age range of 18 to 65 may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly enhance the quality of life for cancer survivors by effectively managing late-onset complications.

How similar studies have performed: Other studies have shown success in managing late effects in cancer survivors, indicating that this approach is promising.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 65 years old.
2. Follow-up at the Léon Bérard center
3. Treated by chemotherapy for one of the following pathologies, and confirmed by the reference diagnostic technique :

   * acute myeloid leukemia;
   * Hodgkin's lymphoma;
   * aggressive non-Hodgkin's lymphoma;
   * primary non-metastatic invasive breast carcinoma;
   * testicular germ cell tumor treated with at least 3 courses of BEP (bleomycin, etoposide, cisplatin), 4 courses of EP (etoposide, cisplatin) or 4 courses of VIP (etoposide, ifosfamide, cisplatin) received;
   * high-grade soft tissue sarcoma, osteosarcoma or Ewing's sarcoma.
4. As a complete response at the end of treatment consultation. If end-of-treatment evaluation is not available at the time of inclusion: as an assumed complete response in the opinion of the investigator based on the previous assessment of response.
5. Whose capacity to practice an adapted physical activity will have been certified by a medical certificate issued by the investigating physician, the general practitioner or the referring physician.
6. Able to understand, read and write French.
7. Available and willing to participate in the project throughout the duration of the study.
8. Living in the Auvergne-Rhône-Alpes region or in the department of Saône-et-Loire
9. Affiliated with a health insurance plan.
10. Having declared an attending physician.
11. Having signed and dated the informed consent.

Exclusion Criteria:

1. With a history of malignancy other than basal cell skin cancer.
2. Cannot be followed for medical, social, family, geographical or psychological reasons for the duration of the study.
3. Participating in other studies that could impact on the evaluation of the judgement criteria.
4. Deprived of liberty by judicial or administrative decision.

Where this trial is running

Lyon

• Centre Leon Berard — Lyon, France (Recruiting)

Study contacts

• Principal investigator: Mauricette MICHALLET, PhD, MD — Centre Leon Berard
• Study coordinator: Romain BUONO, PharmD, MPH

Conditions Late Effects; Testicular Germ Cell Tumor Mixed; Non-Metastatic Breast Carcinoma; Soft Tissue Sarcoma, Adult, Stage IIC; Osteosarcoma; Ewing's Sarcoma; Acute Myeloid Leukemia; Hodgkin Disease