Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention in Oncology Patients

June 1, 2025 updated by: Dilara Sert Kasım, Istanbul University - Cerrahpasa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acceptance and Commitment Therapy Based Intervention for Oncology Patients
Group 1 will participate in a 5-session Acceptance and Commitment Therapy-Based Intervention for Oncology Patients intervention program.
Behavioral: Acceptance and Commitment Therapy-Based Intervention for Oncology Patients
An intervention program was prepared for oncology patients aiming to reduce psychological distress and increase participation in normal life.
Active Comparator: Psychoeducation for Oncology Patients
Group 2 will participate in a 5-session Psychoeducation for Oncology Patients program.
Behavioral: Psychoeducation for Oncology Patients
A program was prepared to support oncology patients in physical and psychological symptom management.
No Intervention: Routine Care
During this period, participants in group 3 will continue their routine treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Distress Thermometer (DT)
Time Frame: 1 day before intervention start
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.
1 day before intervention start
The Distress Thermometer (DT)
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
one month after the end of the interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reintegration to Normal Living Index (RNLI)
Time Frame: 1 day before intervention start
The Reintegration to Normal Living Index (RNLI) has two sub-dimensions. These are: daily functions and self-perceptions. The scale is scored on a five-point Likert scale: Strongly Disagree (1 point), Disagree (2 points), Undecided (3 points), Agree (4 points) and Strongly Agree (5 points). Scores that can be obtained from the scale vary between 11 and 55. A high score on the scale indicates a better level of participation in normal life.
1 day before intervention start
Reintegration to Normal Living Index (RNLI)
Time Frame: through study completion, an average of 1 year
The Reintegration to Normal Living Index (RNLI) has two sub-dimensions. These are: daily functions and self-perceptions. The scale is scored on a five-point Likert scale: Strongly Disagree (1 point), Disagree (2 points), Undecided (3 points), Agree (4 points) and Strongly Agree (5 points). Scores that can be obtained from the scale vary between 11 and 55. A high score on the scale indicates a better level of participation in normal life.
through study completion, an average of 1 year
Reintegration to Normal Living Index (RNLI)
Time Frame: one month after the end of the interventions
The Reintegration to Normal Living Index (RNLI) has two sub-dimensions. These are: daily functions and self-perceptions. The scale is scored on a five-point Likert scale: Strongly Disagree (1 point), Disagree (2 points), Undecided (3 points), Agree (4 points) and Strongly Agree (5 points). Scores that can be obtained from the scale vary between 11 and 55. A high score on the scale indicates a better level of participation in normal life.
one month after the end of the interventions

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Principal Investigator: Dilara Sert Kasım, M.Sc., Istanbul University - Cerrahpasa
  • Principal Investigator: Hülya Bilgin, Ph.D., Istanbul University - Cerrahpasa

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)

June 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

June 8, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

June 1, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IstanbulUC-DSKasım-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Acceptance and Commitment Therapy

Clinical Trials on Acceptance and Commitment Therapy-Based Intervention for Oncology Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe