NCT06745700Not yet recruiting
Impact of Behavioral Activation on Depression and Quality of Life in Patients with Colon Cancer
Impact of Behavioral Activation on Depression, Anxiety, Health-related Quality of Life (HRQoL), Cancer Recurrence and Survival in Patients with Colon Cancer
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this randomized clinical trial is to study anxiety and depression symptoms at diagnosis in patients with colon cancer. Previous studies have shown that so-called. Behavioural activation as therapy for these symptoms has a positive impact on the patient's well-being, but it has not been studied whether it also has a positive impact on the patient's mental health in cancer, and whether it can have a prognostically beneficial effect on cancer recurrence risk and survival. The investigators will investigate the prevalence of anxiety and depression symptoms as well as quality of life in colon cancer patients at diagnosis and at follow-up using self-estimated validated protocols in a prospective cohort study. Data will be compared with data from a reference population. In the cohort study the investigators will also perform a nested randomized clinical trial of a brief psychological treatment called Behavioural Activation to patients with colon cancer and comorbid anxiety and/or depression. All participants will answer the questionnaires at diagnosis, after1, 2 and 6 months and after 1 and 3 years.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- Jan 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Region Västmanland
- Diseases
- Depression, Colorectal cancer, Childhood cancers
- NCT number
- NCT06745700
What you commit to
- Study type: Interventional
- Planned participants: 400
- From Jan 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ongoing or previous manic episode
Other illness
- ongoing alcohol or substance use syndrome
- ongoing psychotic disorder, severe depression
- cognitive illness/dementia
Other
- language difficulties that cause patients to be unable to absorb the treatment
- elevated suicide risk
- antidepressant treatment initiated within the last month
- ongoing psychological treatment.
Who the study is looking for
- All patients diagnosed with colon cancer in Region Västmanland, will be considered for inclusion. Those who meet the inclusion criteria will be offered to participate in the studies after written approval.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Clinical research and Dept. of Surgery Coordinator of this site? Confirm its status | Västerås | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.