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Impact of Genetic Counseling on Knowledge and Anxiety among Breast Cancer Patients at Risk of Genetic Mutation

Impact of Genetic Counseling on Knowledge and Anxiety among Breast Cancer Patients at Risk of Genetic Mutation: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260210004
Enrollment
48
Registered
2026-02-10
Start date
2026-02-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Hereditary cancer risk Anxiety Breast Neoplasms Genetic Counseling Genetic Mutation Anxiety Health Knowledge

Interventions

Participants receive a structured genetic counseling program delivered by trained staff. The program includes family history assessment, hereditary breast cancer risk education, discussion of genetic
Structured Genetic Counseling Program,control

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Participants who meet one or more of the following criteria will be eligible for inclusion in the study: 1. Breast cancer patients with indications of risk for genetic mutation, defined by any of the following conditions: 1.1 Diagnosis of breast cancer at age 50 years or younger. 1.2 Diagnosis of breast cancer with one of the following characteristics: a. History of recurrent breast cancer on the same side or a second primary cancer, including bilateral breast cancer, synchronous primary cancers diagnosed within less than 6 months, or metachronous primary cancers diagnosed more than 6 months apart. b. Diagnosis of lobular breast cancer (ILC) with a family history of gastric cancer. c. History of sarcoma. d. History of adrenocortical carcinoma, glioma, or choroid plexus carcinoma. e. History of other types of cancer diagnosed at age 45 years or younger. 1.3 Diagnosis of triple negative breast cancer (TNBC). 1.4 Diagnosis of breast cancer at any age with one of the following family history characteristics: a. At least two first or second degree relatives with breast cancer or prostate cancer. b. At least one first or second degree relative with breast cancer diagnosed at age 50 years or younger or a male breast cancer. c. At least one first or second degree relative with ovarian cancer, pancreatic cancer, or sarcoma. d. At least one first or second degree relative diagnosed with cancer at age 45 years or younger. 2. Participants who are conscious, cognitively intact, and able to understand and communicate in Thai. 3. Participants who are willing to participate in the study and provide written informed consent. 4. Participants or their caregivers who have access to a smartphone and are able to use the LINE application.

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Breast cancer patients who have previously undergone genetic testing for BRCA1, BRCA2, or other hereditary cancer related genes prior to receiving care at the Cancer and General Disease Clinic, Surin Hospital. 2. Breast cancer patients with a history of, or currently receiving treatment for, psychiatric disorders that may impair communication or decision making capacity, such as dementia, schizophrenia, or uncontrolled psychiatric symptoms. 3. Breast cancer patients who are physically debilitated, severely ill, or in a critical medical condition, such as those requiring mechanical ventilation, experiencing shock, in terminal stage disease, or those who are unable to participate continuously in the research activities. 4. Breast cancer patients who are under legal constraints, such as court ordered custody or detention, which may limit their ability to provide independent and voluntary consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
Knowledge of hereditary breast cancer and genetic mutation Baseline and 4 weeks after intervention Researcher-developed genetic knowledge questionnaire

Secondary

MeasureTime frame
anxiety level Baseline and 4 weeks after intervention State-Trait Anxiety Inventory (STAI)

Countries

Thailand

Contacts

Public ContactThiya Nusairam

Surin Hospital, Ministry of Public Health, Thailand

thiya.n@kkumail.com0817901569

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026