ong-term follow-up of breast cancer survivors: A randomized controlled study

Not Applicable

• Conditions: Breast cancer survivorship; Cancer; Breast cancer

• Registration Number: ISRCTN15403211
• Lead Sponsor: Koo Foundation Sun Yat-Sen Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-06
• Last Update Posted: 25 April 2022
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 902

Inclusion Criteria

1. Aged from 18 to 100
2. Female
3. Stage 0,1,2,3 breast cancer
4. Underwent breast cancer surgery within 9 months from enrollment

Exclusion Criteria

1. Other active cancer
2. Renal failure on dialysis
3. Heart failure NYHA class III or IV
4. Cirrhosis Child B or C
5. Severe COPD
6. Active tuberculosis
7. Moderate to severe cognitive dysfunction
8. Any condition resulting in the individual unable to receive breast cancer follow-up care at KF-SYSCC

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast cancer survivor specific quality of life (physical health and mental health) are measured using the Breast Cancer Prevention Trial (BCPT) symptom scale, the Patient Health Questionnaire for depression PHQ9 and anxiety GAD7, and the SF-36 health survey at 6, 12, 18, 24, 30, 36 months after surgery.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Patient satisfaction is measured using a patient satisfaction survey developed for this study at 12, 18, 24, 30, 36 months after surgery<br> 2. Medication adherence is measured using a patient survey developed for this study at 12, 18, 24, 30, 36 months after surgery<br> 3. Cancer recurrence confirmation and serious clinical events are measured using patient survey and by reviewing medical records at 18, 24, 30, 36 months after surgery<br> 4. Healthcare utilization is measured using claims data at the completion of the study<br> 5. Preventive care is measured using patient survey and by reviewing medical records at 18, 24, 30, 36 months after surgery<br> 6. Management of chronic disease is measured using patient survey and by reviewing medical records at 18, 24, 30, 36 months after surgery<br>