JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Other: No intervention; Other: Tailored counseling programs

• Registration Number: NCT06621277
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

JUMP_START aims to assess the needs of individuals aged ≤ 50 years with gastrointestinal (GI) tumors and implement a tailored support and counseling program at the University Hospital Heidelberg and the National Center for Tumor Diseases (NCT).

In phase 1A, 12-15 individuals aged ≤ 50 years with GI tumors will be interviewed via telephone using semi-structured interviews to obstain a detailed understanding of the life situation, the burdens, and the care situation within the structures of the NCT Heidelberg.

In phase 1B, the care networks of young patients with GI tumors beyond the NCT, including the analysis of changes and important access routes/possible gatekeepers, will be explored using so-called ego-centered network analyses, in comparison with patients who received a GI tumor diagnosis after the age of 50.

In response to the results of phase 1A and 1B, the care services for young patients with GI tumors will be optimized, and tailored counseling programs will be developed in phase 2.

These project phases will be accompanied by Quality of Life assessments using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires. All patients with GI tumors (regardless of potential inclusion in phase 1A or 1B) will receive the EORTC questionnaires once. In phase 2, Quality of Life will be assessed every 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-28
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Individuals aged ≥ 18 and ≤ 50 years receiving treatment for a GI tumor at the Heidelberg University Hospital
• Sufficient knowledge of the German language
• Capable of providing informed consent
• Additional recruitment for Phase 1B and Quality of Life assessments: Patients with GI tumor aged ≥ 51 years

Exclusion Criteria

• Individuals with a GI tumor diagnosis after the age of 50 (except in Phase 1B and for Quality of Life assessments)
• Individuals with a GI tumor diagnosis under the age of 18
• Lack of capacity to consent and/or absence of informed consent
• Insufficient knowledge of the German language
• Severe cognitive impairments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals received a GI tumor diagnosis > 50 years	No intervention	-
Individuals received a GI tumor diagnosis ≤ 50 years	Tailored counseling programs	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Quality of Life at two years	Baseline, 6; 12; 18, and 24 months	Changes in Quality of Life in patients aged ≤ 50 years with a GI tumor diagnosis who are using optimized counseling programs will be measured using EORTC questionnaires (e.g. EORTC-QLQ C30, EORTC QLQ-CR29, EORTC LMC21, EORTC HCC18, EORTC QLQ-OG25). Scores will be categorized into functional and symptom scales (0-100 range) following the EORTC Scoring Manual. For Functional scales and Global QoL: Higher scores indicate better functioning or better QoL. For Symptom scales: Higher scores indicate greater symptom burden.

Trial Locations

Locations (1)

National Center for Tumor Diseases (NCT) Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany