NCT05035173

The LYSA (Linking You to Support and Advice) Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University College Cork · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Survivorship
• Breast Cancer
• Cervical Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
OTHER	Survivorship Clinic Assessments	Patients will visit in person the Survivorship Clinic at the baseline and end of the study (12-month) at the ORCHID center in the Cork University Hospital (Cork, Ireland). During these visits, baseline and end of the study assessments will be made. Patients will receive routine standard information, a care plan and resources about survivorship at the baseline visit.
OTHER	Survivorship Clinic Nurse Resource	Patients will receive a Survivorship Personal Treatment Plan by the nurse from the Women's Health Initiative Survivorship Clinic according to the results from the baseline ePROs. In addition to that, each 2 months for a period of 12 months, the patient will be answering ePROs. The nurse will undertake an intervention when needed based as per the Trigger system (developed form ePROs responses) or clinical judgement. \- ePRO Symptom Survey Instrument (nurse questions): A core list of symptoms/adverse events that are identified including gastrointestinal, attention/memory, pain, fatigue and insomnia, mood-emotional distress/depression, anxiety, fear of cancer recurrence, gynaecological, urinary, sexual issues, hot flashes.
OTHER	Survivorship Clinic Dietitian Resource	Patients will receive Diet Education and Personalised Nutrition Counselling by the dietitian from the Women's Health Initiative Survivorship Clinic at the baseline. In addition to that, each 2 months for a period of 12 months, the patient will be answering ePROs. The dietitian will undertake an intervention when needed as per the Trigger system (developed form ePROs responses) or clinical judgement. \- ePRO Symptom Survey Instrument (diet questions): nutritional risk (lack of appetite; worry regarding weight loss; worry regarding weight gain), weight, and exercise.

Timeline

• Start date: 2021-03-13
• Primary completion: 2023-09-20
• Completion: 2026-03-02
• First posted: 2021-09-05
• Last updated: 2026-03-04

Locations

1 site across 1 country: Ireland