The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Pat… (NCT07742969) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes
156 participantsStarted 2026-08-15
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
* 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.
Exclusion Criteria:
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:
* 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 anot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Self-Care Behavior
Timeframe: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.
2
Patient Anxiety Assessed by the Beck Anxiety Inventory
Timeframe: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.
3
Caregiver Anxiety Assessed by the Beck Anxiety Inventory
Timeframe: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.
4
Caregiver Burden Assessed by the Zarit Burden Interview
Timeframe: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.