Social Media on Prescription for Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

— SMOP  

Official title:

SMOP - Social Media on Prescription, a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658044
• Other study ID #: SMOP
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 10, 2021

Study information

• Verified date: November 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim with this study is to get a deeper understanding of the potential benefits with a health platform for patients diagnosed with colorectal cancer.

Description:

This is a prospective randomized parallel group design. Consecutive patients will be recruited from participating hospitals and randomized to either "prescribed participation" or just receiving information about the platform but with no prescription.

All patients are also receiving standard care. After treatment all patients will receive information about the platform and the aim with the platform. A short demonstration of the platform will also be provided. The platform will contain general information on "Life after cancer treatment". It will be a forum to discuss with fellow-patients, both experienced and newly treated and it is also possible to address questions to health professionals. After the demonstration an information about the study will be given and patients will be asked to participate. If accepted a consent form will be presented and signed by the patients. All patients will be given an alias - a username, to be used at the platform which gives the patients confidentiality. However, as this is a research project they will be informed that their clinical data will be extracted from their patient charts. The alias will in a separate file be connected with their personal identification number. The patients randomized to intervention (prescribed participation) will be offered to contact a research nurse or researcher if they have any practical questions regarding the use of the platform. All patients will be asked to answer a questionnaire at baseline, 3, 6 and 12 months after surgery. Patients will be answering the questionnaires electronically on the platform or in a paper version sent by ordinary mail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 10, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colorectal cancer diagnosis within 1 year

• Must be able to speak and read the Swedish language

• Must be able to use the health platform

Exclusion Criteria:

-Inability to speak and read the Swedish language

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Participation in the internet forum
Active participation in the forum with encouragement to participate on a weekly basis
• Placebo
No intervention performed. Patients are offered to read the open pages on the website

Locations

Country	Name	City	State
Sweden	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Högskolan Väst

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self empowerment measured by Cancer Behavior Inventory (CBI) scale	A 12-item measure of self-efficacy for coping with cancer that measures self empowerment and coping. Each question is answered on a 9 point Likert scale. The higher the score the more confident and self empowered	12 months
Secondary	Self empowerment measured by Cancer Behavior Inventory (CBI) scale	A 12-item measure of self-efficacy for coping with cancer that measures self empowerment and coping. Each question is answered on a 9 point Likert scale. The higher the score the more confident and self empowered	3 months
Secondary	Compliance to treatment	How frequent is the forum used? Will be tested using newly developed questions in a questionnaire. There will be a scale from 1-5	12 months
Secondary	Quality of life using a Likert scale question tested in several other studies	Using an assessment on a Likert scale 0-7 "How would you rate your QoL?"	12 months
Secondary	Usability of a health care platform	Is the platform easy to use? Will be tested using newly developed questions with 4-6 answering options.	12 months
Secondary	Generated Knowledge in Online Discussions	A qualitative analysis of the online discussions on the forum	3 years