Clinical trial · Interventional
The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Caregiver | — | UNRESOLVED | — |
| Caregiver Anxiety | — | UNRESOLVED | — |
| Caregiver Burden | — | UNRESOLVED | — |
| Dyadic Intervention | — | UNRESOLVED | — |
| Education | — | UNRESOLVED | — |
| Self Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dyadic Self Care Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dyadic self care education
- description
- 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).
- interventionNames
- Behavioral: Dyadic Self Care Education
- type
- NO_INTERVENTION
- label
- Routine Care Control
- description
- 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.
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 another person.
References
Publications (0)
Data not yet available