The LYSA (Linking You to Support and Advice) 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.

Conditions

• Survivorship
• Breast Cancer
• Cervical Cancer
• Endometrial Cancer

Interventions

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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  collaborator OTHER

• Irish Cancer Society

  collaborator OTHER

• Breakthrough Cancer Research

  collaborator UNKNOWN

• Cancer Research@UCC

  collaborator UNKNOWN

• Cancer Trials Cork

  collaborator UNKNOWN

• Clinical Research Facilites - Cork (CRF-C)

  collaborator UNKNOWN

• Cork University Hospital

  collaborator OTHER

• Enhancing Cancer Awareness and Survivorship Programmes (ECASP)

  collaborator UNKNOWN

• University College Cork

  lead OTHER

Principal Investigators

• Kate O Connell, Ms. · Research Support Officer Clinical (Nurse Manager)

• Laia Raigal, Dr. · Data Manager

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-13

Primary Completion

2023-09-20

Completion

2026-03-02

Countries

• Ireland

Study Locations