Status:
UNKNOWN
A Guided Internet-delivered Individually-tailored ACT-influenced CBT Intervention to Improve Psychosocial Outcomes in Breast Cancer
Lead Sponsor:
Linkoeping University
Collaborating Sponsors:
Universidade Nova de Lisboa
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy to improve care c...
Detailed Description
Background: Breast Cancer (BC) ranks as the most frequent and lethal cancer among women, in Portugal. However, advances in cancer detection and treatment contributed to a steady and significant increa...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Age ≥ 18 years;
- Ability to read and write in Portuguese.
- History of histologically or cytologically confirmed breast cancer with no evidence of metastatic disease.
- An interval ≥ 6 month from primary adjuvant treatment completion (surgery, chemotherapy and/or radiotherapy), except for hormonal therapy.
- Clinically significant symptoms of at least one of the following conditions: anxiety, depression, fatigue, insomnia and/or sexual dysfunction.
- Ongoing regular psychoactive medication only accepted if dosage has been stable during the last 3 months.
- Daily access to the Internet by computer and/or smartphone.
- Ability to use a computer and/or smartphone and the internet.
- No participation on any other interventional study or clinical trial.
Exclusion
- Age ≤ 18 years;
- Inability to co-operate and give informed consent.
- Breast cancer not histologically or cytologically confirmed.
- History of other malignancy within the last 5 years.
- Metastasized breast cancer.
- Current severe, uncontrolled systemic disease or mental disorder.
- Absence of clinically significant symptoms.
- Parallel ongoing psychological treatment.
- Ongoing regular psychoactive medication if dosage has been changed during the last 3 months.
- No access to the internet.
- Inability to use a computer and/or smartphone and the internet.
- Parallel ongoing participation in other interventional study or clinical trial.
- Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03275727
Start Date
February 1 2018
End Date
December 1 2019
Last Update
September 8 2017
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