Pretreatment Group Consultation for Patients With Colorectal Cancer

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03888313
• Collaborator: (none)
• Enrollment: 161
• Location: 1
• Actual Duration (Months): 20.6
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasm	Other: Pretreatment group consultation

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

• Study Type: Observational
• Actual Enrollment: 161 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pretreatment Group Consultation for Patients With Colorectal Cancer
• Actual Study Start Date: Apr 26, 2019
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Jan 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; A consultation in group with several patients and one surgeon

Outcome Measures

Primary Outcome Measures

1. The patient's experience of participating in a pretreatment group consultation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients participating in the pretreatment group consultation

Exclusion Criteria:

• Not able to answer questionnaire

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital/Östra	Gothenburg	Västra Götaland Region	Sweden	SE 416 85

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

• Study Chair: Eva Angenete, MD, PhD, Sahlgrenska University Hospital, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eva Haglind, MD, PhD, professor, Principal Investigator Clinical Professor Eva Haglind, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT03888313
• Other Study ID Numbers: INFOM
• First Posted: Mar 25, 2019
• Last Update Posted: Sep 29, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Sep 29, 2021