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Clinical Trials/NCT06457178
NCT06457178
Recruiting
N/A

Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention on Psychological Distress and Reintegration Into Normal Life in Oncology Patients

Istanbul University - Cerrahpasa1 site in 1 country75 target enrollmentJune 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acceptance and Commitment Therapy
Sponsor
Istanbul University - Cerrahpasa
Enrollment
75
Locations
1
Primary Endpoint
The Distress Thermometer (DT)
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of Acceptance and Commitment Therapy Based Intervention for Oncology Patients. The main questions it aims to answer are:

  • Does the Acceptance and Commitment to Therapy-Based Intervention for Oncology Patients affect the level of psychological distress?
  • Does the Acceptance and Commitment to Therapy-Based Intervention for Oncology Patients affect the level of reintegration into normal life?

Researchers will compare Acceptance and Commitment Therapy-Based Intervention for Oncology Patients (ACT) to Psychoeducation for Oncology Patients and routine care (with no specific intervention) to see if Acceptance and Commitment Therapy-Based Intervention for Oncology Patients is effective in psychological distress and reintegration into normal living.

Detailed Description

Participants: * They will be randomly divided into three groups (Group 1: ACT, Group 2: Psychoeducation, Group 3: Routine care). * All participants will be asked to complete data collection forms. * Group 1 will participate in a 5-session Acceptance and Commitment Therapy-Based Intervention for Oncology Patients intervention program. * Group 2 will participate in a 5-session Psychoeducation for Oncology Patients program. * During this period, participants in group 3 will continue their routine treatment. * After completion of the interventions, participants will be asked to complete the data collection forms again. * The researchers will then analyze the results and write the report.

Registry
clinicaltrials.gov
Start Date
June 1, 2025
End Date
January 30, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Dilara Sert Kasım

Doctorate Student

Istanbul University - Cerrahpasa

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older,
  • Being able to read and write,
  • Receiving oncologic treatment,
  • Being diagnosed with breast cancer,
  • To know about Medical Diagnosis,
  • Being in stage 1, 2 or 3 of the disease,
  • Receiving outpatient chemotherapy treatment only,
  • Internet access and computer skills to participate in online group interviews,
  • Low to moderate scores on the brief psychological resilience scale,

Exclusion Criteria

  • Having serious psychiatric or cognitive impairments that limit adherence to group sessions,
  • Having a physical disability that may make it difficult to participate in group sessions,
  • Failure to attend sessions regularly and absenteeism,
  • Currently being in a psychoeducation/psychotherapy group

Outcomes

Primary Outcomes

The Distress Thermometer (DT)

Time Frame: one month after the end of the interventions

The scale was developed to measure psychological distress in cancer patients. The problems in the list are grouped into five areas. These are daily life problems, family problems, emotional problems, faith-related problems, and physical problems. The patient marks which one or which areas of the list he/she has experienced problems in the last week. The cut-off point of the scale in our country was found to be 4. The National Comprehensive Cancer Network (NCCN) argues that patients who score 5 or above on the distress thermometer are in significant distress and should be supported by professionals.

Secondary Outcomes

  • Reintegration to Normal Living Index (RNLI)(one month after the end of the interventions)

Study Sites (1)

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