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Social Media on Prescription for Colorectal Cancer Patients (SMOP)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Participation in the internet forum
Placebo
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Participation in the internet forum

No participation in the internet forum

Arm Description

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

"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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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?"
Usability of a health care platform
Is the platform easy to use? Will be tested using newly developed questions with 4-6 answering options.
Generated Knowledge in Online Discussions
A qualitative analysis of the online discussions on the forum

Full Information

First Posted
August 30, 2018
Last Updated
November 4, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Högskolan Väst
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1. Study Identification

Unique Protocol Identification Number
NCT03658044
Brief Title
Social Media on Prescription for Colorectal Cancer Patients
Acronym
SMOP
Official Title
SMOP - Social Media on Prescription, a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Högskolan Väst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel group study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participation in the internet forum
Arm Type
Experimental
Arm Description
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
Arm Title
No participation in the internet forum
Arm Type
Active Comparator
Arm Description
"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.
Intervention Type
Other
Intervention Name(s)
Participation in the internet forum
Intervention Description
Active participation in the forum with encouragement to participate on a weekly basis
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
No intervention performed. Patients are offered to read the open pages on the website
Primary Outcome Measure Information:
Title
Self empowerment measured by Cancer Behavior Inventory (CBI) scale
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self empowerment measured by Cancer Behavior Inventory (CBI) scale
Description
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
Time Frame
3 months
Title
Compliance to treatment
Description
How frequent is the forum used? Will be tested using newly developed questions in a questionnaire. There will be a scale from 1-5
Time Frame
12 months
Title
Quality of life using a Likert scale question tested in several other studies
Description
Using an assessment on a Likert scale 0-7 "How would you rate your QoL?"
Time Frame
12 months
Title
Usability of a health care platform
Description
Is the platform easy to use? Will be tested using newly developed questions with 4-6 answering options.
Time Frame
12 months
Title
Generated Knowledge in Online Discussions
Description
A qualitative analysis of the online discussions on the forum
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Gellerstedt, Ph.D.
Organizational Affiliation
Högskolan Väst
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Angenete, Ph.D., M.D.
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
City
Gothenburg
ZIP/Postal Code
SE 416 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Social Media on Prescription for Colorectal Cancer Patients

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