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Spots Global Cancer Trial Database for The LYSA (Linking You to Support and Advice) Trial

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Trial Identification

Brief Title: The LYSA (Linking You to Support and Advice) Trial

Official Title: Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial

Study ID: NCT05035173

Study Description

Brief 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.

Detailed 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 HER2-negative per ASCO-CAP guidelines on or recommended to commence adjuvant endocrine therapy during the study period. * Cervical cancer: Stage I to III treated with curative intent. * Endometrial cancer: treated with curative intent adjuvant radiotherapy +/- chemotherapy

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Cork University Hospital, Cork, , Ireland

Contact Details

Name: Kate O Connell, Ms.

Affiliation: Research Support Officer Clinical (Nurse Manager)

Role: STUDY_CHAIR

Name: Laia Raigal, Dr.

Affiliation: Data Manager

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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