NCT03658044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

August 30, 2018

Last Update Submit

November 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (5)

  • Self empowerment measured by Cancer Behavior Inventory (CBI) scale

    3 months

  • Compliance to treatment

    12 months

  • Quality of life using a Likert scale question tested in several other studies

    12 months

  • Usability of a health care platform

    12 months

  • Generated Knowledge in Online Discussions

    3 years

Study Arms (2)

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

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.

Other: Placebo

Interventions

Active participation in the forum with encouragement to participate on a weekly basis

Participation in the internet forum
PlaceboOTHER

No intervention performed. Patients are offered to read the open pages on the website

No participation in the internet forum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer diagnosis within 1 year
  • Must be able to speak and read the Swedish language
  • Must be able to use the health platform

You may not qualify if:

  • Inability to speak and read the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Martin Gellerstedt, Ph.D.

    Högskolan Väst

    PRINCIPAL INVESTIGATOR
  • Eva Angenete, Ph.D., M.D.

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized parallel group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, consultant surgeon

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 5, 2018

Study Start

December 1, 2018

Primary Completion

October 31, 2020

Study Completion

October 10, 2021

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations