NCT03888313

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2021

Completed
Last Updated

September 29, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

March 16, 2019

Last Update Submit

September 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before start of treatment

Study Arms (1)

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).

Other: Pretreatment group consultation

Interventions

A consultation in group with several patients and one surgeon

Patients participating in the pretreatment group consultation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with colon or rectal cancer at the Sahlgrenska University Hospital/Östra planned for surgical treatment

You may qualify if:

  • Patients participating in the pretreatment group consultation

You may not qualify if:

  • Not able to answer questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital/Östra

Gothenburg, Västra Götaland County, SE 416 85, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Eva Angenete, MD, PhD

    Sahlgrenska University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Clinical Professor Eva Haglind

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 25, 2019

Study Start

April 26, 2019

Primary Completion

November 30, 2019

Study Completion

January 13, 2021

Last Updated

September 29, 2021

Record last verified: 2021-01

Locations