Acceptance and Commitment TherapyNCT06457178
Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention in Oncology Patients
A study testing Acceptance and Commitment Therapy-Based Intervention for Oncology Patients and Psychoeducation for Oncology Patients in people with Acceptance and Commitment Therapy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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?… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acceptance and Commitment Therapy
- What is being tested?
- Acceptance and Commitment Therapy-Based Intervention for Oncology Patients and Psychoeducation for Oncology Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hülya Bilgin, Ph.D. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Hospital
Istanbul
Dilara Sert Kasım, 05412679525, dilara.sert@acibadem.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Acceptance and Commitment Therapy
- Being tested
- Acceptance and Commitment Therapy-Based Intervention for Oncology Patients, Psychoeducation for Oncology Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy-Based Intervention for Oncology PatientsBehavioural
An intervention program was prepared for oncology patients aiming to reduce psychological distress and increase participation in normal life.
Psychoeducation for Oncology PatientsBehavioural
A program was prepared to support oncology patients in physical and psychological symptom management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation for Oncology Patients |
| Routine Care | No intervention | During this period, participants in group 3 will continue their routine treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: one month after the end of the interventions
Secondary outcomes (3)
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.
Measured: 1 day before intervention start
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.
Measured: through study completion, an average of 1 year
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.
Measured: one month after the end of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance and Commitment TherapyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Sert Kasım, Istanbul University - Cerrahpasa
- Investigators
- Dilara Sert Kasım, M.Sc., Principal investigator, Istanbul University - CerrahpasaHülya Bilgin, Ph.D., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457178
- Sponsor's protocol ID
- IstanbulUC-DSKasım-001
- Status last verified
- Jun 2025
- First submitted
- 17 May 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention on Psychological Distress and Reintegration Into Normal Life in Oncology Patients
- ClinicalTrials.gov ID
- NCT06457178
- Acronym / sponsor ID
- IstanbulUC-DSKasım-001
- Conditions
- Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy Based Intervention for Oncology Patients | Experimental | Behavioral: Acceptance and Commitment Therapy-Based Intervention for Oncology PatientsGroup 1 will participate in a 5-session Acceptance and Commitment Therapy-Based Intervention for Oncology Patients intervention program. |
| Psychoeducation for Oncology Patients | Active comparator | Behavioral: Psychoeducation for Oncology PatientsGroup 2 will participate in a 5-session Psychoeducation for Oncology Patients program. |
| Routine Care | No intervention | –During this period, participants in group 3 will continue their routine treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy-Based Intervention for Oncology PatientsAn intervention program was prepared for oncology patients aiming to reduce psychological distress and increase participation in normal life. | Behavioural | Acceptance and Commitment Therapy Based Intervention for Oncology Patients |
| Psychoeducation for Oncology PatientsA program was prepared to support oncology patients in physical and psychological symptom management. | Behavioural | Psychoeducation for Oncology Patients |
Primary outcome
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.
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.
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.
3 secondary outcomes
Reintegration to Normal Living Index (RNLI)
Time frame: 1 day before intervention start
Reintegration to Normal Living Index (RNLI)
Time frame: through study completion, an average of 1 year
Reintegration to Normal Living Index (RNLI)
Time frame: one month after the end of the interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hülya Bilgin, Ph.D. contact
Dilara Sert Kasım, M.Sc. principal investigator
Istanbul University - Cerrahpasa
Hülya Bilgin, Ph.D. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy-Based Intervention for Oncology Patients and Psychoeducation for Oncology Patients in people with Acceptance and Commitment Therapy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilara Sert Kasım, M.Sc. ((+90) 541 267 95 25, dilara.sert10@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Distress Thermometer (DT) (time frame: 1 day before intervention start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.