Social Media on Prescription for Colorectal Cancer Patients (SMOP)

SMOP - Social Media on Prescription, a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Participation in the internet forum; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE 416 85
    • Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Participation in the internet forum; Other: Patients will be encouraged to participate in an internet forum communicating with other patients at least once per week. Participation in the internet forum	Other: Participation in the internet forum; Active participation in the forum with encouragement to participate on a weekly basis
ACTIVE_COMPARATOR: No participation in the internet forum; "Placebo" Patients will not be able to enter or read in the forum, but will be able to read general information on the webpage where the forum is placed.	Other: Placebo; No intervention performed. Patients are offered to read the open pages on the website

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Generated Knowledge in Online Discussions	A qualitative analysis of the online discussions on the forum	3 years

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Högskolan Väst
• Investigators: Principal Investigator: Martin Gellerstedt, Ph.D., Högskolan Väst; Principal Investigator: Eva Angenete, Ph.D., M.D., Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): October 31, 2020
• Study Completion (ACTUAL): October 10, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (ACTUAL): September 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SMOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No