Colorectal CancerSTELLANCT02526264
Evaluation of Quality of Life and Period of Hospitalization by Education
A study testing Education program in people with Colorectal Cancer, run by Krankenhaus Nordwest at 2 sites in Germany.
Trial summary
Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesGermany
- Study dates
- 24 Nov 2015to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Planned stoma
- colorectal cancer, from resection of left hemi-colon aboral A. colica media
- Patients speaking german and living in Germany
- ECOG ≤ 3
- Informed Consent
- standard education program
Who cannot join
- Patients treated with stoma by emergency
- patients with dementia
- status post stoma
- Patients in contact with a stoma-therapist
- recurrence of colorectal cancer
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Krankenhaus Nordwest
Frankfurt, 60488
Stefan Berkhoff, Doctor, +49 69 76014016, berkhoff.stefan@khnw.de
- Recruiting
Sana Klinikum
Offenbach, 63069
Ulrike Wauer, MD, +49698405 ext. 7106, ulrike.wauer@sana.de
Beate Mantz, +49698405 ext. 4403, beate.mantz@sana.de
About this study
Official title: Clinical Trial to Evaluate Quality of Life, Period of Hospitalization and Complication Rates in Patients With Stoma Receiving Specific Preoperative Education vs. Standard Preoperative Education
Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.
Read the detailed description
The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B
- Conditions
- Colorectal Cancer
- Being tested
- Education program
- Keywords
- stoma, quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programOther
Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes
| Study group | Role | What they receive |
|---|---|---|
| Krankenhaus Nordwest Concept | Experimental | specific preoperative education program realised by a specialized stoma-therapist containing individualized information on material maintenance, hygiene, nutrition, complications, activities of daily life and occupation Receives: Other: Education program |
| Standard concept | Experimental | standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives Receives: Other: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points
Measured: 9-15 days after surgery
Quality of Life
Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points
Measured: 4 weeks after surgery
Secondary outcomes (2)
Period of hospitalization
Measured: 9-15 days after surgery, 4 weeks after surgery
Complication rates
Measured: 9-15 days after surgery, 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start24 Nov 2015
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526264
- Sponsor's protocol ID
- STELLA
- Acronym
- STELLA
- Status last verified
- Mar 2024
- First submitted
- 10 Aug 2015
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Quality of Life, Period of Hospitalization and Complication Rates in Patients With Stoma Receiving Specific Preoperative Education vs. Standard Preoperative Education
- ClinicalTrials.gov ID
- NCT02526264
- Acronym / sponsor ID
- STELLA / STELLA
- Conditions
- Colorectal Cancer
- Keywords
- stoma, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Krankenhaus NordwestUniversity, hospital or other
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- 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.
Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.
Detailed description
The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krankenhaus Nordwest Concept | Experimental | Other: Education programspecific preoperative education program realised by a specialized stoma-therapist containing individualized information on material maintenance, hygiene, nutrition, complications, activities of daily life and occupation |
| Standard concept | Experimental | Other: Education programstandard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Planned stoma
- colorectal cancer, from resection of left hemi-colon aboral A. colica media
- Patients speaking german and living in Germany
- ECOG ≤ 3
- Informed Consent
Key exclusion criteria (5 listed)
- Patients treated with stoma by emergency
- patients with dementia
- status post stoma
- Patients in contact with a stoma-therapist
- recurrence of colorectal cancer
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 |
|---|---|---|
| Education programVerbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes | Other | Krankenhaus Nordwest Concept, Standard concept |
Primary outcome
Quality of life
Time frame: 9-15 days after surgery
Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points
Quality of Life
Time frame: 4 weeks after surgery
Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points
2 secondary outcomes
Period of hospitalization
Time frame: 9-15 days after surgery, 4 weeks after surgery
Complication rates
Time frame: 9-15 days after surgery, 4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No. No IPD will be shared
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program in people with Colorectal Cancer, run by Krankenhaus Nordwest at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Berkhoff, MD (+49697601 ext. 4016, berkhoff.stefan@khnw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 9-15 days after surgery). The study lists 2 primary outcomes in all. 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 6 Mar 2024.