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NCT Number: NCT06457178

Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention 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.

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Key information

Conditions

Acceptance and Commitment Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Dilara Sert Kasım

CONTACT

[email protected]

05412679525

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Psychoeducation for Oncology Patients

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Sert Kasım, M.Sc.

CONTACT

[email protected]

(+90) 541 267 95 25

Hülya Bilgin, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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