Colorectal CancerSMOPNCT03658044
Social Media on Prescription for Colorectal Cancer Patients
A study testing Participation in the internet forum in people with Colorectal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Participation in the internet forum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2018to 10 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer diagnosis within 1 year
- Must be able to speak and read the Swedish language
- Must be able to use the health platform
Who cannot join
- -Inability to speak and read the Swedish language
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Participation in the internet forum, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in the internet forumOther
Active participation in the forum with encouragement to participate on a weekly basis
PlaceboOther
No intervention performed. Patients are offered to read the open pages on the website
| Study group | Role | What they receive |
|---|---|---|
| Participation in the internet forum | Experimental | 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 Receives: Other: Participation in the internet forum |
| No participation in the internet forum | Active comparator | "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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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?"
Measured: 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.
Measured: 12 months
Generated Knowledge in Online Discussions
A qualitative analysis of the online discussions on the forum
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Dec 2018
- Primary completion31 Oct 2020
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Högskolan Väst
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Martin Gellerstedt, Ph.D., Principal investigator, Högskolan VästEva Angenete, Ph.D., M.D., Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658044
- Sponsor's protocol ID
- SMOP
- Acronym
- SMOP
- Status last verified
- Nov 2022
- First submitted
- 30 Aug 2018
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMOP - Social Media on Prescription, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03658044
- Acronym / sponsor ID
- SMOP / SMOP
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Högskolan Väst
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized parallel group study
| Arm | Type | Receives |
|---|---|---|
| Participation in the internet forum | Experimental | Other: Participation in the internet forumOther: Patients will be encouraged to participate in an internet forum communicating with other patients at least once per week. Participation in the internet forum |
| No participation in the internet forum | Active comparator | Other: Placebo"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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colorectal cancer diagnosis within 1 year
- Must be able to speak and read the Swedish language
- Must be able to use the health platform
Key exclusion criteria (1 listed)
- -Inability to speak and read the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in the internet forumActive participation in the forum with encouragement to participate on a weekly basis | Other | Participation in the internet forum |
| PlaceboNo intervention performed. Patients are offered to read the open pages on the website | Other | No participation in the internet forum |
Primary outcome
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
5 secondary outcomes
Self empowerment measured by Cancer Behavior Inventory (CBI) scale
Time frame: 3 months
Compliance to treatment
Time frame: 12 months
Quality of life using a Likert scale question tested in several other studies
Time frame: 12 months
Usability of a health care platform
Time frame: 12 months
Generated Knowledge in Online Discussions
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Gellerstedt, Ph.D. principal investigator
Högskolan Väst
Eva Angenete, Ph.D., M.D. principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in the internet forum in people with Colorectal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self empowerment measured by Cancer Behavior Inventory (CBI) scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.