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Clinical Trial Summary

This study's aim is to evaluate the feasibility of introducing a women's malignancy survivorship clinic incorporating symptom management through ePRO collection (complex intervention) into routine follow up care in patients with early-stage Hormone Receptor(HR)-positive breast and gynaecologic cancer post primary curative therapy.


Clinical Trial Description

Study Design: Complex interventional study. Specific Aims: To evaluate the feasibility of introducing a women's malignancy survivorship clinic in Ireland incorporating symptom management through electronic Patient Reported Outcomes (ePROs) collection (complex intervention) into routine follow-up care in patients with early-stage HR-positive breast and gynecologic cancer post-primary therapy. Sampling Method: Randomized Control Design (Parallel Arms). Sample Size: 200. Entry Criteria: Women with early-stage breast/gynecologic cancer within 12 months of completion of primary curative therapy: - Breast cancer: Stage I-III hormone receptor-positive (defined as estrogen receptor and/or progesterone receptor ≥ 1% and Human Epidermal growth factor Receptor 2 (HER2) negative per American Society Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines treated with adjuvant chemotherapy and receiving endocrine therapy - Cervical cancer: Stage I to III treated with curative intent chemoradiation - Endometrial cancer: treated with curative intent adjuvant chemotherapy +/- radiotherapy ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035173
Study type Interventional
Source University College Cork
Contact Roisin Connolly, Prof.
Phone +353 21 4922687
Email [email protected]
Status Recruiting
Phase N/A
Start date March 13, 2021
Completion date March 2023

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