Gastrointestinal CancerJUMP_STARTNCT06621277
JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors
An observational study of Gastrointestinal Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Tailored counseling programs (Phase 2)
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2023to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with a GI tumor diagnosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
National Center for Tumor Diseases (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Bruno Christian Köhler, +49 6221 5635676, bruno.koehler@nct-heidelberg.de
About this study
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.
Read more
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
- Being tested
- No intervention, Tailored counseling programs (Phase 2)
- Keywords
- Quality of Life, gastrointestinal tumors
- Medical subject headings
- Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
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)
| Study group | Role | What they receive |
|---|---|---|
| Individuals received a GI tumor diagnosis > 50 years | Not described Receives: Other: No intervention | |
| Individuals received a GI tumor diagnosis ≤ 50 years | Not described Receives: Other: Tailored counseling programs (Phase 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6; 12; 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Christian Köhler, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621277
- Sponsor's protocol ID
- NCT_GI_BCK_02
- Other IDs
- AIO-LQ-0323ass
- Acronym
- JUMP_START
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared for scientific collaborations after agreement with PI.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT06621277
- Acronym / sponsor ID
- JUMP_START / NCT_GI_BCK_02
- Conditions
- Gastrointestinal Cancer
- Keywords
- Quality of Life, gastrointestinal tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with a GI tumor diagnosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Individuals received a GI tumor diagnosis > 50 years |
| 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) | Other | Individuals received a GI tumor diagnosis ≤ 50 years |
Primary outcome
Change from baseline in Quality of Life at two years
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided. Data may be shared for scientific collaborations after agreement with PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno C. Köhler (+49 6221 5635676, jump-start.nct@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Quality of Life at two years (time frame: Baseline, 6; 12; 18, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.