Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Social Media on Prescription for Colorectal Cancer Patients (SMOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658044
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Högskolan Väst
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Participation in the internet forum Other: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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?"

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Eva Angenete, M.D., Ph.D. +46760514441 eva.angenete@vgregion.se
Contact: Emma Andreasson, RN emma.andreasson@vgregion.se

Locations
Layout table for location information
Sweden
Dept. of Surgery, Sahlgrenska University Hospital/Ostra Recruiting
Gothenburg, Sweden, SE 416 85
Contact: Eva Angenete, MD,PhD    +46313438410    eva.angenete@vgregion.se   
Contact: Emma Andreasson, RN    +46313434000    emma.andreasson@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Högskolan Väst
Investigators
Layout table for investigator information
Principal Investigator: Martin Gellerstedt, Ph.D. Högskolan Väst
Principal Investigator: Eva Angenete, Ph.D., M.D. Sahlgrenska University Hospital, Sweden

Layout table for additonal information
Responsible Party: Eva Angenete, Associate professor, consultant surgeon, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03658044    
Other Study ID Numbers: SMOP
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases