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

NCT06621277 | Recruiting

• 2 other identifiers: NCT_GI_BCK_02AIO-LQ-0323ass
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer

Keywords

Quality of Life; gastrointestinal tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Differences in Quality of Life between patients aged ≤ 50 years and > 50 years

  Once at baseline, after enrollment

Study Arms (2)

Individuals received a GI tumor diagnosis > 50 years

Other: No intervention

Individuals received a GI tumor diagnosis ≤ 50 years

Other: Tailored counseling programs (Phase 2)

Interventions

No intervention OTHER

No intervention

Individuals received a GI tumor diagnosis > 50 years

Tailored counseling programs (Phase 2) OTHER

Optimized care services and tailored counseling programs for young patients with GI tumors at the Heidelberg University Hospital (Phase 2)

Individuals received a GI tumor diagnosis ≤ 50 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a GI tumor diagnosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

National Center for Tumor Diseases (NCT) Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Digestive System Neoplasms

Interventions

Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Bruno C. Köhler

CONTACT

+49 6221 5635676; jump-start.nct@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-09

Locations

DE (1)