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

NCT06457178 | Recruiting

• 1 other identifier: IstanbulUC-DSKasım-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (3)

• The Distress Thermometer (DT)

  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)

  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)

  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 Outcomes (3)

• Reintegration to Normal Living Index (RNLI)

  1 day before intervention start

• Reintegration to Normal Living Index (RNLI)

  through study completion, an average of 1 year

• Reintegration to Normal Living Index (RNLI)

  one month after the end of the interventions

Study Arms (3)

Acceptance and Commitment Therapy Based Intervention for Oncology Patients

EXPERIMENTAL

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

Psychoeducation for Oncology Patients

ACTIVE COMPARATOR

Group 2 will participate in a 5-session Psychoeducation for Oncology Patients program.

Behavioral: Psychoeducation for Oncology Patients

Routine Care

NO INTERVENTION

During this period, participants in group 3 will continue their routine treatment.

Interventions

Acceptance and Commitment Therapy-Based Intervention for Oncology Patients BEHAVIORAL

An intervention program was prepared for oncology patients aiming to reduce psychological distress and increase participation in normal life.

Acceptance and Commitment Therapy Based Intervention for Oncology Patients

Psychoeducation for Oncology Patients BEHAVIORAL

A program was prepared to support oncology patients in physical and psychological symptom management.

Psychoeducation for Oncology Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Acibadem Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Dilara Sert Kasım, M.Sc.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Hülya Bilgin, Ph.D.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilara Sert Kasım, M.Sc.

CONTACT

(+90) 541 267 95 25; dilara.sert10@ogr.iuc.edu.tr

Hülya Bilgin, Ph.D.

CONTACT

hulya.bilgin@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate Student

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)