Social Media on Prescription for Colorectal Cancer Patients (SMOP)
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|ClinicalTrials.gov Identifier: NCT03658044|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Participation in the internet forum Other: Placebo||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized parallel group study|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||SMOP - Social Media on Prescription, a Randomised Controlled Trial|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||September 10, 2021|
|Estimated Study Completion Date :||September 10, 2022|
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.
No intervention performed. Patients are offered to read the open pages on the website
- Self empowerment measured by Cancer Behavior Inventory (CBI) scale [ Time Frame: 12 months ]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
- Self empowerment measured by Cancer Behavior Inventory (CBI) scale [ Time Frame: 3 months ]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 [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]Using an assessment on a Likert scale 0-7 "How would you rate your QoL?"
- Usability of a health care platform [ Time Frame: 12 months ]Is the platform easy to use? Will be tested using newly developed questions with 4-6 answering options.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658044
|Contact: Eva Angenete, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Emma Andreasson, RNemail@example.com|
|Principal Investigator:||Martin Gellerstedt, Ph.D.||Högskolan Väst|
|Principal Investigator:||Eva Angenete, Ph.D., M.D.||Sahlgrenska University Hospital, Sweden|