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

Acceptance and Commitment Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457178
• Other study ID #: IstanbulUC-DSKasim-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Dilara Sert Kasim, M.Sc.
• Phone: (+90) 541 267 95 25
• Email: dilara.sert10[@]ogr.iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older,

• Being able to read and write,

• Receiving oncologic treatment,

• Low to moderate scores on the brief psychological resilience scale,

• To know about Medical Diagnosis

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

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy

Intervention

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.
• Psychoeducation for Oncology Patients
A program was prepared to support oncology patients in physical and psychological symptom management.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.	three month after the end of the interventions
Secondary	Reintegration to Normal Living Index (RNLI)	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
Secondary	Reintegration to Normal Living Index (RNLI)	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
Secondary	Reintegration to Normal Living Index (RNLI)	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
Secondary	Reintegration to Normal Living Index (RNLI)	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.	three month after the end of the interventions