Impact of Behavioral Activation on Depression and Quality of Life in Patients with Colon Cancer (BAdepCa)

December 19, 2024 updated by: Catarina Tiselius, Region Västmanland

Impact of Behavioral Activation on Depression, Anxiety, Health-related Quality of Life (HRQoL), Cancer Recurrence and Survival in Patients with Colon Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Colon cancer is common. At diagnosis, about 20% have metastatic disease. The prognosis is determined by the stage of the tumour and the degree of spread, but also by the patient's physical health and other diseases. However, it is not known how the patient's mental health are affected and how common anxiety and depression symptoms are at diagnosis. Depression is known to be one of the most common causes of ill health in the world. It also has been shown that patients with depression and cancer also have a poorer survival rate compared to cancer patients without depression However, previous studies have shown that so-called brief 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.

The goal of this randomized study is to increase knowledge about, to detect and treat anxiety and depression symptoms in patients with colon cancer, with so-called brief behavioural activation, which can lead to improved care, and possibly improve the patients' prognosis in the form of reduced risk of cancer recurrence and improved survival.

All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session telephone-based BA-treatment spread over two months as an add-on to CAU. All participants will answer a questionnaire in the beginning of the study, 4 weeks after diagnosis, after 9 weeks, and after 3-, 6- and 12 months.

The main questions that the trial aims to answer are if the BA-treatment has an effect in the short and long term on:

  • Depressive symptoms
  • Anxiety symptoms
  • Self-rated activation
  • Self efficacy
  • Mental wellbeing
  • Quality of life
  • Cancer recurrence and survival

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Region Västmanland
      • Västerås, Region Västmanland, Sweden, 72189
        • Centre for Clinical research and Dept. of Surgery
        • Contact:
          • Fanny Johansen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • language difficulties that cause patients to be unable to absorb the treatment
  • ongoing alcohol or substance use syndrome
  • elevated suicide risk
  • ongoing psychotic disorder, severe depression
  • antidepressant treatment initiated within the last month
  • ongoing or previous manic episode
  • cognitive illness/dementia
  • ongoing psychological treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief Behavioural Activation
Five-session Brief Behavioral Activation intervention. Sessions 1 - 4 are completed once a week, and session 5 is a booster-session completed four weeks after session 4 and care as usual provided by Region Västmanland.
Behavioral: Brief Behavioural Activation

Behavioral: Brief Behavioral Activation.

A five-session telephone-based brief behavioral activation treatment.

Session 1: Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log.

Session 2: Discussion of life goals and values; planning of activities aligned with life goals and values for coming week.

Session 3-4: Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for coming week.

Session 5: Troubleshooting any problems carrying out activities; reviewing treatment; stressing the importance of continuing to engage in activities aligned. with life goals and values; creating a a maintenance plan.

Other group: care as usual.

Other: Care as usual
Care as usual provided by Region Västamanland,
Other: Care as Usual
Care as usual provided by Västmanland County hospital.
Other: Care as usual
Care as usual provided by Region Västamanland,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression Symptoms: Hospital Anxiety and Depression Scale, HADS
Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
The HADS consists of 14 questions, of which 7 constitute a depression scale and 7 constitute an anxiety scale. The points from the seven different statements per subscale are added together and can amount to a maximum of 21 points per subscale. Min 0 and maximum 42 points. Higher scores indicate more anxiety and depression symptoms.
Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
Mental well-being
Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
The short version of the Warwick-Edinburgh Mental Well-being Scale, SWEMWBS. The scores from the seven statements are summed up and vary between minimum 7 and maximum 35 points. Higher scores indicate better psychological well-being.
Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
Health-related quality of life (HRQoL )
Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L (Feng et al., 2021). The self-assessment scale consists of sub-questions; five questions with five different answer options where the score varies between 1-5 points, where higher scores indicate better HRQoL.
Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
Behavioral Activation for Depression Scale - Short Form BADS-SF
Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
Rating scale with two subscales where one scale sums up activation and the other about avoidant behavior. The scale varies between 0-54 points, with higher scores indicating more activation.
Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
Perceived self-efficacy
Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.
Swedish translation of The New General Self-Efficacy Scale S- GSE. The total score of the rating scale varies between 10-40 points where higher scores indicate a higher self-perceived self-efficacy.
Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic markers
Time Frame: Measurement 3 and 5 years after diagnosis and treatment.
Recurrence (3 and 5 years), metastasis (local recurrence and distant metastases), cause of deathe and survival (DFS and OS at 3 and 5 years).
Measurement 3 and 5 years after diagnosis and treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Västmanland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTV-1011976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified outcome measure IPD will be shared upon reasonable requests from academic researchers.

IPD Sharing Time Frame

Study protocol and statistical analysis plan to be shared/published before data collection has ended.

IPD Sharing Access Criteria

Data will be shared upon reasonable requests assessed by the investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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