Clinical trial NCT06621277: JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors
Official title: JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Cancer
Keywords: Quality of Life
gastrointestinal tumors
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a GI tumor diagnosis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Quality of Life at two years
timeFrame: Baseline, 6; 12; 18, and 24 months
Secondary outcomes:
Other outcomes:
measure: Differences in Quality of Life between patients aged ≤ 50 years and > 50 years
timeFrame: Once at baseline, after enrollment
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumor Diseases (NCT) Heidelberg
state: Baden-Württemberg
Study officials:
References: