NCT05035173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

April 26, 2021

Last Update Submit

March 2, 2026

Conditions

Endometrial CancerSurvivorshipBreast CancerCervical Cancer

Keywords

SurvivorshipComplex Interventional StudyRandomisedElectronic Patient Reported OutcomesBreast CancerCervical CancerEndometrial CancerNurse Lead ClinicDietitian InterventionNurse interventionSymptom ManagementQuality of LifeSelf-care Agency

Outcome Measures

Primary Outcomes (6)

  • Number of patients enrolled in the clinic.

    Number of patients who were eligible and accepted to participate in the study. This will be recorded in the electronic Case Report Forms (eCRF).

    At the baseline

  • Reasons for not enrolling to the study.

    The reasons for not enrolling will be asked to the patient considering and clusters of option groups will be done.This will be recorded in the electronic Case Report Forms (eCRF).

    At the baseline

  • Reasons for not completing the intervention (drop out).

    Patients will be contacted to ask about the reasons for not completing the intervention. This will be recorded in the electronic Case Report Forms (eCRF).

    During the study period (12-month)

  • Percentage of adherence to the intervention completing ePROs surveys

    Number of enrolled patients who complete the baseline and follow-up ePRO surveys. This will be recorded in the ePROs.

    Baseline, each 2 months till end intervention (12 months)

  • Number of patients who partake in healthcare professional consultations after ePRO data triggers.

    A trigger system with the ePRO measurements has been developed to assess symptoms deterioration that will require that the nurse or Dietitian contact the patient. This will be recorded in the electronic Case Report Forms (eCRF).

    Baseline, each 2 months till end intervention (12 months)

  • Average consultation time in the Womens Survivorship Clinic.

    Time spent by the Nurse, the Dietitian and other Health Care Professionals (HCP) from the Women Survivorship Clinic during consultation will be collected. This will be recorded in the electronic Case Report Forms (eCRF).

    Baseline, each 2 months till end intervention (12 months)

Secondary Outcomes (19)

  • Change from Baseline in cancer-related symptoms scores assessed by Patient-Reported Outcomes.

    Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10

  • Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).

    Both arms at the baseline and at the end of the intervention (12-month)

  • Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) Breast Cancer Module scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).

    Both arms at the baseline and at the end of the intervention (12-month)

  • Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) Cervical Cancer Module scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).

    Both arms at the baseline and at the end of the intervention (12-month)

  • Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) Endometrial Cancer Module scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).

    Both arms at the baseline and at the end of the intervention (12-month)

  • +14 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will have available the services offered by the Women's Cancer Survivorship Clinic and will undertake electronic Patient Reported Outcomes at baseline, 2, 4, 6, 8, 10, 12 months (end of the study).

Other: Survivorship Clinic AssessmentsOther: Survivorship Clinic Nurse ResourceOther: Survivorship Clinic Dietitian Resource

Control Arm

ACTIVE COMPARATOR

Participants will attend a baseline and end of the study visit (12-month time point) to the Women's Cancer Survivorship Clinic to undertake the baseline and complete end of study assessments. They will complete ePRO at baseline and at 12 months. They will have usual follow up care over the 12 month period of the study. Where participants in the control arm contact the Survivorship team for clinical or other advice, they will be referred to the usual care pathway.

Other: Survivorship Clinic Assessments

Interventions

Survivorship Clinic AssessmentsOTHER

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.

Control ArmIntervention Arm
Survivorship Clinic Nurse ResourceOTHER

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.

Also known as: Complex Intervention
Intervention Arm
Survivorship Clinic Dietitian ResourceOTHER

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.

Also known as: Complex Intervention
Intervention Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged \> or = 18 years.
  • Ability to read and understand English.
  • Access to internet.
  • Early-stage breast/gynaecologic 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

You may not qualify if:

  • Patients who are not treated with curative intent as above.
  • Patients with premalignant disease.
  • Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol.
  • Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship). Note: Per discretion of PI as to whether may impact the outcome of this study intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Cork, T12 DFK4, Ireland

Location

Related Publications (1)

  • Kearns N, Raigal-Aran L, O'Connell K, Davis A, Bermingham K, O'Reilly S, Collins DC, Corrigan M, Coulter J, Cleary V, Cushen S, Flavin A, Byrne F, O'Grady A, O'Neill D, Murphy A, Dahly D, Palmer B, Connolly RM, Hegarty J. The Women's Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial. Pilot Feasibility Stud. 2022 Nov 10;8(1):238. doi: 10.1186/s40814-022-01186-x.

    PMID: 36357934DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kate O Connell, Ms.

    Research Support Officer Clinical (Nurse Manager)

    STUDY CHAIR

  • Laia Raigal, Dr.

    Data Manager

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2021

First Posted

September 5, 2021

Study Start

March 13, 2021

Primary Completion

September 20, 2023

Study Completion

March 2, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Not applicable at the moment.

Locations

IE(1)