SMOP: Social Media on Prescription for Colorectal Cancer Patients

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03658044
Collaborator
Högskolan Väst (Other)
44
1
2
48.3
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Participation in the internet forum
  • Other: Placebo
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized parallel group studyRandomized 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 :
Dec 1, 2018
Actual Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Dec 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Self empowerment measured by Cancer Behavior Inventory (CBI) scale [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 [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 [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 [12 months]

    Using an assessment on a Likert scale 0-7 "How would you rate your QoL?"

  4. Usability of a health care platform [12 months]

    Is the platform easy to use? Will be tested using newly developed questions with 4-6 answering options.

  5. Generated Knowledge in Online Discussions [3 years]

    A qualitative analysis of the online discussions on the forum

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg Sweden SE 416 85

Sponsors and Collaborators

  • Sahlgrenska University Hospital, Sweden
  • Högskolan Väst

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eva Angenete, Associate professor, consultant surgeon, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT03658044
Other Study ID Numbers:
  • SMOP
First Posted:
Sep 5, 2018
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2021