Breast CancerNCT07742969
The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes
A study testing Dyadic Self Care Education in people with Breast Cancer and Caregiver, run by Ulviye Aydan NACAK at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of dyadic self-care education provided to breast cancer patient-caregiver dyads receiving outpatient chemotherapy on patient self-care behaviors, anxiety levels, and caregiver anxiety levels and caregiver burden. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Caregiver, Caregiver Anxiety
- What is being tested?
- Dyadic Self Care Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2026to 24 Oct 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- Female patients aged 18 years or older.
- Diagnosed with stage II or III breast cancer.
- Aware of their breast cancer diagnosis.
- Receiving outpatient chemotherapy after mastectomy.
- Having received at least one cycle of an EC (epirubicin-cyclophosphamide) or AC (doxorubicin-cyclophosphamide) chemotherapy regimen.
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- Able to read and write Turkish.
- Having a primary caregiver who is willing to participate in the study.
- Living with the primary caregiver.
- Conscious, able to communicate effectively, and able to provide informed consent.
- No diagnosed psychiatric disorder.
- Primary Caregivers:
- Aged 18 years or older.
- Able to read and write Turkish.
- Living with the patient.
- Being the patient's spouse, parent, child, friend, or another relative.
- Assuming the main responsibility for the patient's care.
- Willing and able to cooperate and provide informed consent.
- No diagnosed psychiatric disorder.
Who cannot join
- Patients:
- Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
- Admission to an intensive care unit during the study.
- Progression of the disease to stage IV breast cancer.
- Death or loss to follow-up.
- Primary Caregivers:
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- Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
- Deterioration in health that prevents continued participation.
- Transfer of the primary caregiving responsibility to another person.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes: Self-Care Behavior, Anxiety Level, and Caregiver Burden
This randomized controlled trial aims to evaluate the effect of dyadic self-care education provided to breast cancer patient-caregiver dyads receiving outpatient chemotherapy on patient self-care behaviors, anxiety levels, and caregiver anxiety levels and caregiver burden. Participants will be randomly assigned to either a dyadic self-care education intervention or routine care. Outcomes will be assessed at baseline and follow-up using validated instruments.
- Conditions
- Breast Cancer, Caregiver, Caregiver Anxiety, Self Care, Dyadic Intervention, Education
- Being tested
- Dyadic Self Care Education
- Keywords
- breast cancer, dyadic self care, education, self care behaviour, anxiety, caregiver burden
- Medical subject headings
- Breast Neoplasms, Caregiver Burden, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Self Care EducationBehavioural
A structured dyadic self-care education program for breast cancer patient-primary caregiver dyads receiving outpatient chemotherapy. One patient and one primary caregiver constitute one dyad. The intervention includes four weekly face-to-face education sessions focusing on the management of chemotherapy-related side effects, self-care maintenance, symptom monitoring, infection prevention, nutrition, fatigue, oral care, skin care, medication adherence, and caregiver support. Assessments will be conducted at baseline, immediately after the four-week intervention, and at a one-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic self care education | Experimental | A structured dyadic self-care education program will be provided to 39 dyads. Each dyad consists of one breast cancer patient receiving chemotherapy and one primary caregiver. The intervention consists of four weekly face-to-face education sessions focusing on symptom management, self-care behaviors, and collaborative patient-caregiver participation in care. Outcomes will be assessed at baseline, immediately after completion of the four-week intervention (post-test), and one month after the post-intervention assessment (follow-up). Receives: Behavioral: Dyadic Self Care Education |
| Routine Care Control | No intervention | The control arm will include 39 dyads. Each dyad consists of one breast cancer patient receiving chemotherapy and one primary caregiver. Participants will receive routine nursing care provided by the clinic and will not receive the dyadic self-care education program. Outcomes will be assessed at baseline, after four weeks, and at a one-month follow-up after the post-intervention assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Self-Care Behavior
Patient self-care behavior will be assessed using the Self-Care Behaviors Scale Based on the Self-Care Deficit Nursing Theory for Patients Receiving Chemotherapy. The scale consists of 24 items rated on a 5-point Likert scale from 1 (never) to 5 (always). Items 11, 20, and 23 are reverse scored. Total scores range from 24 to 120, with higher scores indicating better self-care behaviors. The scale includes six subdimensions: personal care, sleep pattern, maintenance of respiration, activity and mobility, nutritional habits, and coping with problems.
Measured: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Patient Anxiety Assessed by the Beck Anxiety Inventory
Patient anxiety will be assessed using the Beck Anxiety Inventory (BAI). The inventory consists of 21 items rated on a 4-point Likert scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are interpreted as follows: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety.
Measured: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Caregiver Anxiety Assessed by the Beck Anxiety Inventory
Caregiver anxiety will be assessed using the Beck Anxiety Inventory (BAI). The inventory consists of 21 items rated on a 4-point Likert scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are interpreted as follows: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety.
Measured: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Caregiver Burden Assessed by the Zarit Burden Interview
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). The scale consists of 22 items rated from 0 (never) to 4 (always). There are no reverse-scored items. Total scores range from 0 to 88, with higher scores indicating greater perceived caregiver burden. Scores are interpreted as follows: below 21, no burden; 21-40, mild burden; 41-60, moderate burden; and 61-88, severe burden.
Measured: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start17 Aug 2026
- Primary completion24 Oct 2026
- Study completion24 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Participants will be randomly assigned in a 1:1 ratio to either the dyadic self-care education intervention group or the routine care control group. Outcomes will be assessed at baseline and follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulviye Aydan NACAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulviye Aydan NACAK, Ataturk University
- Investigators
- Mağfiret Kaşıkçı, Professor, PhD, Principal investigator, Atatürk University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742969
- Sponsor's protocol ID
- AU-BC-DYAD-26
- Other IDs
- SDK-2026-17003
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes: Self-Care Behavior, Anxiety Level, and Caregiver Burden
- ClinicalTrials.gov ID
- NCT07742969
- Acronym / sponsor ID
- AU-BC-DYAD-26
- Conditions
- Breast Cancer, Caregiver, Caregiver Anxiety, Self Care, Dyadic Intervention, Education
- Keywords
- breast cancer, dyadic self care, education, self care behaviour, anxiety, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Ulviye Aydan NACAKUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 24 Oct 2026 (actual)
- Study completion
- 24 Oct 2026 (actual)
- First posted
- 3 Aug 2026 (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 randomized controlled trial aims to evaluate the effect of dyadic self-care education provided to breast cancer patient-caregiver dyads receiving outpatient chemotherapy on patient self-care behaviors, anxiety levels, and caregiver anxiety levels and caregiver burden. Participants will be randomly assigned to either a dyadic self-care education intervention or routine care. Outcomes will be assessed at baseline and follow-up using validated instruments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the dyadic self-care education intervention group or the routine care control group. Outcomes will be assessed at baseline and follow-up.
| Arm | Type | Receives |
|---|---|---|
| Dyadic self care education | Experimental | Behavioral: Dyadic Self Care EducationA structured dyadic self-care education program will be provided to 39 dyads. Each dyad consists of one breast cancer patient receiving chemotherapy and one primary caregiver. The intervention consists of four weekly face-to-face education sessions focusing on symptom management, self-care behaviors, and collaborative patient-caregiver participation in care. Outcomes will be assessed at baseline, immediately after completion of the four-week intervention (post-test), and one month after the post-intervention assessment (follow-up). |
| Routine Care Control | No intervention | –The control arm will include 39 dyads. Each dyad consists of one breast cancer patient receiving chemotherapy and one primary caregiver. Participants will receive routine nursing care provided by the clinic and will not receive the dyadic self-care education program. Outcomes will be assessed at baseline, after four weeks, and at a one-month follow-up after the post-intervention assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Female patients aged 18 years or older.
- Diagnosed with stage II or III breast cancer.
- Aware of their breast cancer diagnosis.
- Receiving outpatient chemotherapy after mastectomy.
- Having received at least one cycle of an EC (epirubicin-cyclophosphamide) or AC (doxorubicin-cyclophosphamide) chemotherapy regimen.
Key exclusion criteria (9 listed)
- Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
- Admission to an intensive care unit during the study.
- Progression of the disease to stage IV breast cancer.
- Death or loss to follow-up.
- Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
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 |
|---|---|---|
| Dyadic Self Care EducationA structured dyadic self-care education program for breast cancer patient-primary caregiver dyads receiving outpatient chemotherapy. One patient and one primary caregiver constitute one dyad. The intervention includes four weekly face-to-face education sessions focusing on the management of chemotherapy-related side effects, self-care maintenance, symptom monitoring, infection prevention, nutrition, fatigue, oral care, skin care, medication adherence, and caregiver support. Assessments will be conducted at baseline, immediately after the four-week intervention, and at a one-month follow-up. | Behavioural | Dyadic self care education |
Primary outcome
Patient Self-Care Behavior
Time frame: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Patient self-care behavior will be assessed using the Self-Care Behaviors Scale Based on the Self-Care Deficit Nursing Theory for Patients Receiving Chemotherapy. The scale consists of 24 items rated on a 5-point Likert scale from 1 (never) to 5 (always). Items 11, 20, and 23 are reverse scored. Total scores range from 24 to 120, with higher scores indicating better self-care behaviors. The scale includes six subdimensions: personal care, sleep pattern, maintenance of respiration, activity and mobility, nutritional habits, and coping with problems.
Patient Anxiety Assessed by the Beck Anxiety Inventory
Time frame: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Patient anxiety will be assessed using the Beck Anxiety Inventory (BAI). The inventory consists of 21 items rated on a 4-point Likert scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are interpreted as follows: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety.
Caregiver Anxiety Assessed by the Beck Anxiety Inventory
Time frame: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Caregiver anxiety will be assessed using the Beck Anxiety Inventory (BAI). The inventory consists of 21 items rated on a 4-point Likert scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are interpreted as follows: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety.
Caregiver Burden Assessed by the Zarit Burden Interview
Time frame: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). The scale consists of 22 items rated from 0 (never) to 4 (always). There are no reverse-scored items. Total scores range from 0 to 88, with higher scores indicating greater perceived caregiver burden. Scores are interpreted as follows: below 21, no burden; 21-40, mild burden; 41-60, moderate burden; and 61-88, severe burden.
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality.
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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.
Mağfiret Kaşıkçı, Professor, PhD principal investigator
Atatürk University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Self Care Education in people with Breast Cancer and Caregiver, run by Ulviye Aydan NACAK 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 19 inclusion and 9 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 28 Oct 2026. 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?
Patient Self-Care Behavior (time frame: Baseline (before the 4-week educational intervention), 1 week after completion of the 4-week educational intervention (post-test), and 1 month after the post-test (follow-up).). The study lists 4 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 28 Oct 2026.