Colorectal NeoplasmNCT03888313
Pretreatment Group Consultation for Patients With Colorectal Cancer
An observational study of Colorectal Neoplasm, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
An explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- Pretreatment group consultation
- How many people
- 161 participants
- Where
- 1 siteSweden
- Study dates
- 26 Apr 2019to 13 Jan 2021
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colon or rectal cancer at the Sahlgrenska University Hospital/Östra planned for surgical treatment
Who may be able to join
- Patients participating in the pretreatment group consultation
Who cannot join
- Not able to answer questionnaire
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital/Östra
Gothenburg, Västra Götaland County, SE 416 85
About this study
An explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer
Read the detailed description
The group consultation is planned to be on the Friday of the same week as the patient recieved a suggested treatment plan i.e. after MDT, at a personal consultation with his/her colorectal surgeon. During the group consultation the steps necessary for the patient to take responsability for in connection with the operation. Ample time for questions, clarifications and discussions. Appropriate clinical trials are presented
- Conditions
- Colorectal Neoplasm
- Being tested
- Pretreatment group consultation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretreatment group consultationOther
A consultation in group with several patients and one surgeon
| Study group | Role | What they receive |
|---|---|---|
| Patients participating in the pretreatment group consultation | Patients who chosse to participate in a group consultation (with other patients also in the process of undergoing surgery for colorectal cancer). Receives: Other: Pretreatment group consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's experience of participating in a pretreatment group consultation
A questionnaire with questions on the patient's experience of the information received and their experience of participating in the pretreatment group consultation will be used to collect descriptive data. Some of the questions have been developed through semi-structured interviews with patients with colon or rectal cancer other are standardized questionnaires used in other studies.
The questionnaire includes questions on which information resources the patients have used (such as social media, patient organizations).Their experience of the pretreatment group consultation will be assessed by "Would you recommend someone in the same situation as you to attend the pretreatment group consultation?". Possible answering options are "Yes", "No" and "Don't know". The EuroQol's EQ-5D-5L for assessment of health related quality of will be included mainly as a tool for assurance of external validity, and not as an outcome measure. Both the indices and the VAS-scale may be used.
Measured: Before start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start26 Apr 2019
- Primary completion30 Nov 2019
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, MD, PhD, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888313
- Sponsor's protocol ID
- INFOM
- Status last verified
- Jan 2021
- First submitted
- 16 Mar 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walming S, Angenete E, Bock D, Block M, de la Croix H, Wedin A, Haglind E. Preoperative Group Consultation Prior to Surgery for Colorectal Cancer-an Explorative Study of a New Patient Education Method. J Cancer Educ. 2022 Oct;37(5):1304-1311. doi: 10.1007/s13187-020-01951-7. Epub 2021 Jan 14.
PubMed 33447870
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment Group Consultation for Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03888313
- Acronym / sponsor ID
- INFOM
- Conditions
- Colorectal Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 25 Mar 2019 (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.
An explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer
Detailed description
The group consultation is planned to be on the Friday of the same week as the patient recieved a suggested treatment plan i.e. after MDT, at a personal consultation with his/her colorectal surgeon. During the group consultation the steps necessary for the patient to take responsability for in connection with the operation. Ample time for questions, clarifications and discussions. Appropriate clinical trials are presented
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients participating in the pretreatment group consultation | – | Other: Pretreatment group consultationPatients who chosse to participate in a group consultation (with other patients also in the process of undergoing surgery for colorectal cancer). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon or rectal cancer at the Sahlgrenska University Hospital/Östra planned for surgical treatment
Key inclusion criteria (1 listed)
- Patients participating in the pretreatment group consultation
Key exclusion criteria (1 listed)
- Not able to answer questionnaire
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 |
|---|---|---|
| Pretreatment group consultationA consultation in group with several patients and one surgeon | Other | Patients participating in the pretreatment group consultation |
Primary outcome
The patient's experience of participating in a pretreatment group consultation
Time frame: Before start of treatment
A questionnaire with questions on the patient's experience of the information received and their experience of participating in the pretreatment group consultation will be used to collect descriptive data. Some of the questions have been developed through semi-structured interviews with patients with colon or rectal cancer other are standardized questionnaires used in other studies. The questionnaire includes questions on which information resources the patients have used (such as social media, patient organizations).Their experience of the pretreatment group consultation will be assessed by "Would you recommend someone in the same situation as you to attend the pretreatment group consultation?". Possible answering options are "Yes", "No" and "Don't know". The EuroQol's EQ-5D-5L for assessment of health related quality of will be included mainly as a tool for assurance of external validity, and not as an outcome measure. Both the indices and the VAS-scale may be used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Results publication: PubMed 33447870Walming S, Angenete E, Bock D, Block M, de la Croix H, Wedin A, Haglind E. Preoperative Group Consultation Prior to Surgery for Colorectal Cancer-an Explorative Study of a New Patient Education Method. J Cancer Educ. 2022 Oct;37(5):1304-1311. doi: 10.1007/s13187-020-01951-7. Epub 2021 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
Eva Angenete, MD, PhD study chair
Sahlgrenska University Hospital
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 Colorectal Neoplasm, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's experience of participating in a pretreatment group consultation (time frame: Before start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888313, which also lists 1 linked publication.
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 29 Sep 2021.