JMIR Publications

ABSTRACT

Background:

Despite significant improvements in cancer survival, late complications from oncological treatments remain inadequately managed in routine clinical practice. Standard oncology follow-up prioritizes disease recurrence detection over systematic assessment of treatment-related sequelae, resulting in underdiagnosis of physical, psychological, metabolic, and social complications that substantially impair survivors' quality of life. The temporal dynamics of complication emergence remain poorly characterized, limiting development of evidence-based surveillance schedules.

Objective:

This study aims to determine the time-specific incidence of 19 predefined treatment-related complications at 1, 6, 24, and 60 months following completion of first-line chemotherapy in adult cancer survivors who achieved complete response. Secondary objectives include characterizing temporal trajectories to identify critical surveillance windows, evaluating the feasibility and performance of a standardized guideline-based referral system integrated within a regional healthcare network, and identifying predictive factors for complication occurrence and timing.

Objective:

This study aims to determine the time-specific incidence of 19 predefined treatment-related complications at 1, 6, 24, and 60 months following completion of first-line chemotherapy in adult cancer survivors who achieved complete response. Secondary objectives include characterizing temporal trajectories to identify critical surveillance windows, evaluating the feasibility and performance of a standardized guideline-based referral system integrated within a regional healthcare network, and identifying predictive factors for complication occurrence and timing.

Methods:

PASCA-c is a single-center, prospective, interventional cohort study conducted at Centre Léon Bérard (Lyon, France). Over 36 months, 500 adults aged 18–65 years with complete responses to first-line therapy for lymphomas (Hodgkin/non-Hodgkin), acute myeloid leukemia, testicular germ cell tumors, non-metastatic breast cancer, or sarcomas will undergo systematic screening at 1 month (T1), 6 months (T2), 24 months (T3), and 60 months (T4) post-treatment. Each assessment includes validated questionnaires, biomarker analyses, cardiovascular evaluations, spirometry, and functional performance tests covering 19 complication domains. Clinical decision trees based on French and international guidelines generate standardized referral recommendations. Patients are referred to a regional network of 120+ healthcare professionals for complication management while continuing standard oncological follow-up. The primary outcome is the time-specific incidence of each complication at T1, T2, T3, and T4, distinguishing new-onset cases from persistent complications detected at prior assessments.

Results:

Patient enrollment began in September 2020 and is ongoing. Final results are anticipated in 2027 upon completion of 60-month follow-up assessments for the last enrolled participant.

Conclusions:

PASCA-c represents the first large-scale European study systematically evaluating the temporal dynamics of 19 treatment-related complications across multiple cancer types. By characterizing time-specific incidence patterns, this study will identify critical surveillance windows for each complication, informing the development of evidence-based, temporally-optimized survivorship care protocols that can be adapted to diverse healthcare settings. Clinical Trial: The study protocol (version_3_03-15-2022) was approved by the French ethics committee (Comité de protection des personnes Ile de France IV, ID-RCB: 2020-A01130-39). The study is registered on ClinicalTrials.gov (NCT04052126). All participants will be asked to sign and date an informed consent form. The results will be published in peer-reviewed journals and academic conferences. The study data have been declared to the ‘Commission nationale de l'informatique et des libertés’ via the reference methodology MR-001 n° R201-001-006.