Clinical trial NCT06457178: Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention in Oncology Patients
Official title: Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention on Psychological Distress and Reintegration Into Normal Life in Oncology Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acceptance and Commitment Therapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Distress Thermometer (DT)
timeFrame: 1 day before intervention start
measure: The Distress Thermometer (DT)
timeFrame: through study completion, an average of 1 year
measure: The Distress Thermometer (DT)
timeFrame: one month after the end of the interventions
Secondary outcomes:
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: 1 day before intervention start
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: through study completion, an average of 1 year
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: one month after the end of the interventions
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Dilara Sert Kasım, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Hülya Bilgin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: