An observational study in Gastrointestinal Cancer, sponsored by University Hospital Heidelberg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by University Hospital Heidelberg · Observational
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.
795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.
This study's planned enrollment of 250 is above the median of 198 across 181 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.
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Individuals with a GI tumor diagnosis
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Exclusion Criteria:
Other: No intervention
Other: Tailored counseling programs (Phase 2)
No intervention
Optimized care services and tailored counseling programs for young patients with GI tumors at the Heidelberg University Hospital (Phase 2)
Change from baseline in Quality of Life at two years
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.
Time frame: Baseline, 6; 12; 18, and 24 months
Differences in Quality of Life between patients aged ≤ 50 years and > 50 years
Differences in Quality of Life in patients aged ≤ 50 years and \> 50 years with a GI tumor diagnosis 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.
Time frame: Once at baseline, after enrollment
Plan to share: Undecided — Data may be shared for scientific collaborations after agreement with PI.
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