Breast Cancer Patients DiagnosedNCT06546787
The Effect of Interpersonal Relationships Psychotherapy on Breast Cancer Patients
A study testing PSYCHOTHERAPY in people with Breast Cancer Patients Diagnosed, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned to examine the effect of Interpersonal Relationship Psychotherapy on depression, interpersonal emotion regulation and multidimensional perceived social support levels of breast cancer patients with depression risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer Patients Diagnosed
- What is being tested?
- PSYCHOTHERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Being a pediatric oncology/hematology patient
- Diagnosed with stage -IV breast cancer
- Taking psychopharmacological medication
- To have received KIPT within the last year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University
Istanbul, Nursing Department, 34020
About this study
Official title: The Effect of Interpersonal Relationships Psychotherapy on Depression, Emotion Regulation and Social Support Levels in Breast Cancer Patients With Depression Risk: A Randomized Controlled Study
This study is planned to examine the effect of Interpersonal Relationship Psychotherapy on depression, interpersonal emotion regulation and multidimensional perceived social support levels of breast cancer patients with depression risk.
Read the detailed description
There are not enough studies showing the effect of IPT, which is an evidence-based psychotherapy that works on problem areas such as role change that may occur with the disease and provides support for recognizing and using social support mechanisms, on cancer patients. This study is thought to make a significant contribution to the literature, especially in terms of making family support, which has an important place in social support systems, available to patients, intervening in interpersonal emotion regulation problems that may occur in patients and affecting depression levels.
- Conditions
- Breast Cancer Patients Diagnosed
- Being tested
- PSYCHOTHERAPY
- Keywords
- Depression, Emotion Regulation, Social Support, Interpersonal Relationships, Breast Cancer
- Medical subject headings
- Depression, Emotional Regulation, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSYCHOTHERAPYOther
Also called interpersonal psychotherapy
IPT, was prepared by the researcher who completed the interpersonal relations psychotherapy training.The first interview will be conducted face-to-face in the offices of Koç University Faculty of Nursing. Subsequent sessions will be conducted via Zoom according to the availability of the patients included in the study. The day and time of the interviews will be planned according to the availability of the patients before the interviews. A total of 12 interviews are planned to be conducted with a patient for 40-60 minutes each. Interview intervals will be organized as once a week.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | IPT will be administered by the researcher who has completed the interpersonal relations psychotherapy training. Receives: Other: PSYCHOTHERAPY |
| Observation | No intervention | Patients in the control group will be asked to complete the post-tests at the same time after the experimental group interviews are completed. However, no intervention will be made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Screening Scale for Primary Care
Each question has four answers. The lowest possible score is zero and the highest possible score is three. A total maximum score of 21 and a minimum score of zero can be achieved. Depression scores of breast cancer patients are expected to decrease after treatment. It is expected to fall below 4 points.
Measured: Through study completion, an average of 6 months
Interpersonal relationships emotion regulation scale
The highest score that can be obtained from the scale is 100 and the lowest score is 20. The high score obtained from each sub-dimension of the scale indicates that the individual has the characteristic evaluated by the relevant sub-dimension. Scores obtained from the scale were found to be related to the total score of the Difficulties in Emotion Regulation Scale and also to depression and anxiety.An increase in the interpersonal relations emotion regulation scale score is expected in breast cancer patients after treatment. This increase shows that it has a positive effect on individuals' emotion regulation.
Measured: Through study completion, an average of 6 months
Multidimensional Perceived Social Support Scale:
The lowest score that can be obtained from the scale is "12" and the highest score is "84". An increase in the total score of the scale means an increase in the level of perceived social support. Social support scores of breast cancer patients are expected to increase after treatment.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Aug 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Patients DiagnosedStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546787
- Sponsor's protocol ID
- 0036315
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interpersonal Relationships Psychotherapy on Depression, Emotion Regulation and Social Support Levels in Breast Cancer Patients With Depression Risk: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06546787
- Acronym / sponsor ID
- 0036315
- Conditions
- Breast Cancer Patients Diagnosed
- Keywords
- Depression, Emotion Regulation, Social Support, Interpersonal Relationships, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 9 Aug 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.
This study is planned to examine the effect of Interpersonal Relationship Psychotherapy on depression, interpersonal emotion regulation and multidimensional perceived social support levels of breast cancer patients with depression risk.
Detailed description
There are not enough studies showing the effect of IPT, which is an evidence-based psychotherapy that works on problem areas such as role change that may occur with the disease and provides support for recognizing and using social support mechanisms, on cancer patients. This study is thought to make a significant contribution to the literature, especially in terms of making family support, which has an important place in social support systems, available to patients, intervening in interpersonal emotion regulation problems that may occur in patients and affecting depression levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Other: PSYCHOTHERAPYIPT will be administered by the researcher who has completed the interpersonal relations psychotherapy training. |
| Observation | No intervention | –Patients in the control group will be asked to complete the post-tests at the same time after the experimental group interviews are completed. However, no intervention will be made to the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Being a pediatric oncology/hematology patient
- Diagnosed with stage -IV breast cancer
- Taking psychopharmacological medication
- To have received KIPT within the last year
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 |
|---|---|---|
| PSYCHOTHERAPYAlso: interpersonal psychotherapyIPT, was prepared by the researcher who completed the interpersonal relations psychotherapy training.The first interview will be conducted face-to-face in the offices of Koç University Faculty of Nursing. Subsequent sessions will be conducted via Zoom according to the availability of the patients included in the study. The day and time of the interviews will be planned according to the availability of the patients before the interviews. A total of 12 interviews are planned to be conducted with a patient for 40-60 minutes each. Interview intervals will be organized as once a week. | Other | Psychotherapy |
Primary outcome
Beck Depression Screening Scale for Primary Care
Time frame: Through study completion, an average of 6 months
Each question has four answers. The lowest possible score is zero and the highest possible score is three. A total maximum score of 21 and a minimum score of zero can be achieved. Depression scores of breast cancer patients are expected to decrease after treatment. It is expected to fall below 4 points.
Interpersonal relationships emotion regulation scale
Time frame: Through study completion, an average of 6 months
The highest score that can be obtained from the scale is 100 and the lowest score is 20. The high score obtained from each sub-dimension of the scale indicates that the individual has the characteristic evaluated by the relevant sub-dimension. Scores obtained from the scale were found to be related to the total score of the Difficulties in Emotion Regulation Scale and also to depression and anxiety.An increase in the interpersonal relations emotion regulation scale score is expected in breast cancer patients after treatment. This increase shows that it has a positive effect on individuals' emotion regulation.
Multidimensional Perceived Social Support Scale:
Time frame: Through study completion, an average of 6 months
The lowest score that can be obtained from the scale is "12" and the highest score is "84". An increase in the total score of the scale means an increase in the level of perceived social support. Social support scores of breast cancer patients are expected to increase after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSYCHOTHERAPY in people with Breast Cancer Patients Diagnosed, run by Koç University 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 0 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Screening Scale for Primary Care (time frame: Through study completion, an average of 6 months). 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 8 Sep 2025.