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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Other: No intervention; Other: Tailored counseling programs (Phase 2)

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Bruno C. Köhler; Phone Number: +49 6221 5635676; Email: jump-start.nct@med.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • National Center For Tumor Diseases (NCT) Heidelberg
      • Contact: Bruno Christian Köhler; Phone Number: +49 6221 5635676; Email: bruno.koehler@nct-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with a GI tumor diagnosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals received a GI tumor diagnosis > 50 years	Other: No intervention; No intervention
Individuals received a GI tumor diagnosis ≤ 50 years	Other: Tailored counseling programs (Phase 2); Optimized care services and tailored counseling programs for young patients with GI tumors at the Heidelberg University Hospital (Phase 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6; 12; 18, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once at baseline, after enrollment

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; gastrointestinal tumors
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: NCT_GI_BCK_02; AIO-LQ-0323ass (Other Identifier: AIO Germany)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be shared for scientific collaborations after agreement with PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No