SurvivorshipLYSANCT05035173
The LYSA (Linking You to Support and Advice) Trial
A study testing Survivorship Clinic Assessments, Survivorship Clinic Nurse Resource and Survivorship Clinic Dietitian Resource in people with Survivorship and Breast Cancer, run by University College Cork at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Survivorship, Breast Cancer, Cervical Cancer
- What is being tested?
- Survivorship Clinic Assessments, Survivorship Clinic Nurse Resource and Survivorship Clinic Dietitian Resource
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- 13 Mar 2021to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial
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.
Read the 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
- Being tested
- Survivorship Clinic Assessments, Survivorship Clinic Nurse Resource, Survivorship Clinic Dietitian Resource
- Keywords
- Survivorship, Complex Interventional Study, Randomised, Electronic Patient Reported Outcomes, Breast Cancer, Cervical Cancer, Endometrial Cancer, Nurse Lead Clinic, Dietitian Intervention, Nurse intervention, Symptom Management, Quality of Life, Self-care Agency
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Survivorship Clinic Nurse ResourceOther
Also called Complex Intervention
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.
Survivorship Clinic Dietitian ResourceOther
Also called Complex Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Survivorship Clinic Assessments; Other: Survivorship Clinic Nurse Resource; Other: 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. Receives: Other: Survivorship Clinic Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
The cancer-related symptoms items will be assessed by the validated Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) item library and Patient-Reported Outcomes Measurement Information System (PROMIS) item library.
Measured: 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).
All patients will answer at the baseline and at the end of the intervention EORTC QLQ-C30 (30 items). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.
Measured: 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).
Cohort of patients who had breast cancer will answer at the baseline and at the end of the intervention EORTC QLQ Breast Cancer Module (BR23). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.
Measured: 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).
Cohort of patients who had cervical cancer will answer at the baseline and at the end of the intervention EORTC QLQ Cervical Cancer Module (CX24). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.
Measured: 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).
Cohort of patients who had endometrial cancer will answer at the baseline and at the end of the intervention EORTC QLQ Endometrial Cancer Module (EN24). The scoring will be performed according to the EORTC scoring manual. All scores will be linearly transformed to a 0 to 100 scale. A high or healthy level of functioning represents a high functional score.
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in EuroQol 5-Level 5-Dimensions quality-adjusted life-year version (EQ-5D-5L-QALY) scores.
All patients will answer the EQ-5D-5L-QALY at the baseline and at the end of the intervention. A high score represents high functionality problems.
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Appraisal Self-Care Agency-R scores (15 items).
All patients will answer at the baseline and at the end of the intervention the Appraisal Self-Care Agency-R (15 items). The higher the score, the better the self-care agency
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in adjuvant endocrine therapy medication adherence.
All patients will self-report their adherence at the baseline and at the end of the study. The intervention arm will be asked about it every 2 months.
Measured: Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10
Assessment of Usability and Satisfaction of the survivorship clinic will be assessed by the Usability and Satisfaction Scale (Lewis, 1995).
Patients in the intervention arm will complete the Usability and Satisfaction Scale (Lewis, 1995) at the end of the intervention. The higher the score, the better usability and satisfaction from the participant.
Measured: Intervention arms at the end of the intervention (12-month)
Experience and opinions from patients, HCP and wider stakeholders about the Women Survivorship Study including the clinic.
Qualitative data collection will be done via Interviews/Focus Groups at the end of the intervention.
Measured: Intervention arms at the end of the intervention (12-month)
Number of resources used by each patient with a cancer related symptom to evaluate the economic impact.
The main sources from which this data will be collected include: patient hospital record forms, case report forms, use of resources forms, and patient diaries.
Measured: Both arms at the end of the intervention (12-month)
Change from Baseline in Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ).
All patients will answer at the baseline and at the end of the intervention the FFQ. All patients will answer at the baseline and at the end of the intervention the Food Frequency Questionnaire. Data will be entered in to the FFQ European Prospective Investigation into Cancer and Nutrition (EPIC) Tool for Analysis (FETA). FETA calculates the average daily intake of 46 nutrients and 14 food groups, for each individual. The default nutrients list provides a description of each nutrient/food group and the units used. The nutrient data for the FFQ foods have come from McCance and Widdowson's "The Composition of Foods (5th edition)" and its associated supplements.
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Diet quality scores from The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) standardised scoring system (Shams-White et al 2019).
All patients will answer at the baseline and at the end of the intervention the WCRF/AICR. The higher the score, the better Diet quality.
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in BMI scores.
The dietitian will perform physical assessments of each patient at the baseline and at the end of the study. Weight and height will be combined to report BMI in kg/m^2. Patients in the intervention arm will self-report weight in kg every 2 months.
Measured: Both arms at the baseline and at the end of the intervention (12-month); intervention arm each 2 months
Change from Baseline in Lean Body Mass (LBM) scores.
The dietitian will perform physical assessments of each patient at the baseline and at the end of the study. Weight and body fat will be combined to report LBM in kg*(Percentage body/100).
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in waist circumference scores.
The dietitian will perform physical assessments of each patient at the baseline and at the end of the study. Waist circumference will be measured in cm.
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Segmental Body Composition scores assessed measured by Body Composition Monitor bioimpedance spectroscopy (BIS).
The dietitian will perform physical assessments on each patient at the baseline and at the end of the study. Weight (Kg) and body fat (%) and Total Body Water (TBW) will be combined to report the Body Composition score.
Measured: Both arms at the baseline and at the end of the intervention (12-month).
Change from Baseline in muscle strength scores on handgrip measurements.
The dietitian will perform physical assessments to each patient at the baseline and at the end of the study. Muscle strength will be measured using hand grip strength (HGS) based on the Jamar Dynamometer (Model 091011725).
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Nutritional risk scores assessed by the Malnutrition Screening Tool (MST). The higher the score, the higher risk of malnutrition.
All patients will complete the MST at the baseline and at the end of the intervention. Patients in the intervention arm answer the MST each 2 months. The higher the score, the higher risk of malnutrition.
Measured: Both arms at the baseline and at the end of the intervention (12-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start13 Mar 2021
- Primary completion20 Sep 2023
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Irish Cancer Society, Breakthrough Cancer Research, Cancer Research@UCC, Cancer Trials Cork, Clinical Research Facilites - Cork (CRF-C), Cork University Hospital, Enhancing Cancer Awareness and Survivorship Programmes (ECASP)
- Responsible party
- Principal investigator, Roisin Connolly, University College Cork
- Investigators
- Kate O Connell, Ms., Study chair, Research Support Officer Clinical (Nurse Manager)Laia Raigal, Dr., Study chair, Data Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035173
- Sponsor's protocol ID
- R19258
- Other IDs
- WHI19CON, BCR-2019-09-ICS-UCC
- Acronym
- LYSA
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable at the moment.
Publications
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.
PubMed 36357934
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial
- ClinicalTrials.gov ID
- NCT05035173
- Acronym / sponsor ID
- LYSA / R19258
- Conditions
- Survivorship, Breast Cancer, Cervical Cancer, Endometrial Cancer
- Keywords
- Survivorship, Complex Interventional Study, Randomised, Electronic Patient Reported Outcomes, Breast Cancer, Cervical Cancer, Endometrial Cancer, Nurse Lead Clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Irish Cancer Society, Breakthrough Cancer Research, Cancer Research@UCC, Cancer Trials Cork, Clinical Research Facilites - Cork (CRF-C), Cork University Hospital, Enhancing Cancer Awareness and Survivorship Programmes (ECASP)
- Study start
- 13 Mar 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Survivorship Clinic Assessments, Other: Survivorship Clinic Nurse Resource, Other: Survivorship Clinic Dietitian ResourceParticipants 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). |
| Control Arm | Active comparator | Other: Survivorship Clinic AssessmentsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivorship Clinic AssessmentsPatients 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 | Control Arm, Intervention Arm |
| Survivorship Clinic Nurse ResourceAlso: Complex InterventionPatients 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 | Intervention Arm |
| Survivorship Clinic Dietitian ResourceAlso: Complex InterventionPatients 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. | Other | Intervention Arm |
Primary outcome
Number of patients enrolled in the clinic.
Time frame: At the baseline
Number of patients who were eligible and accepted to participate in the study. This will be recorded in the electronic Case Report Forms (eCRF).
Reasons for not enrolling to the study.
Time frame: At the baseline
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).
Reasons for not completing the intervention (drop out).
Time frame: During the study period (12-month)
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).
Percentage of adherence to the intervention completing ePROs surveys
Time frame: Baseline, each 2 months till end intervention (12 months)
Number of enrolled patients who complete the baseline and follow-up ePRO surveys. This will be recorded in the ePROs.
Number of patients who partake in healthcare professional consultations after ePRO data triggers.
Time frame: Baseline, each 2 months till end intervention (12 months)
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).
Average consultation time in the Womens Survivorship Clinic.
Time frame: Baseline, each 2 months till end intervention (12 months)
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).
19 secondary outcomes
Change from Baseline in cancer-related symptoms scores assessed by Patient-Reported Outcomes.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in EuroQol 5-Level 5-Dimensions quality-adjusted life-year version (EQ-5D-5L-QALY) scores.
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Appraisal Self-Care Agency-R scores (15 items).
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in adjuvant endocrine therapy medication adherence.
Time frame: Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10
Assessment of Usability and Satisfaction of the survivorship clinic will be assessed by the Usability and Satisfaction Scale (Lewis, 1995).
Time frame: Intervention arms at the end of the intervention (12-month)
Experience and opinions from patients, HCP and wider stakeholders about the Women Survivorship Study including the clinic.
Time frame: Intervention arms at the end of the intervention (12-month)
Number of resources used by each patient with a cancer related symptom to evaluate the economic impact.
Time frame: Both arms at the end of the intervention (12-month)
Change from Baseline in Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ).
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Diet quality scores from The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) standardised scoring system (Shams-White et al 2019).
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in BMI scores.
Time frame: Both arms at the baseline and at the end of the intervention (12-month); intervention arm each 2 months
Change from Baseline in Lean Body Mass (LBM) scores.
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in waist circumference scores.
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Segmental Body Composition scores assessed measured by Body Composition Monitor bioimpedance spectroscopy (BIS).
Time frame: Both arms at the baseline and at the end of the intervention (12-month).
Change from Baseline in muscle strength scores on handgrip measurements.
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Change from Baseline in Nutritional risk scores assessed by the Malnutrition Screening Tool (MST). The higher the score, the higher risk of malnutrition.
Time frame: Both arms at the baseline and at the end of the intervention (12-month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Derived from this study: PubMed 36357934Kearns 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.
- Women's Health Initiative - Cancer survivorship support for womenLink provided by the sponsor.
- Women's Cancer Survivorship: Supporting And Innovating For ChangeLink provided by the sponsor.
- Short video about the Women's Health Initiative pilot clinic in CorkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable at the moment.
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Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
RecruitingPhase 3
Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
Endometrial Adenocarcinoma, Metastatic Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate O Connell, Ms. study chair
Research Support Officer Clinical (Nurse Manager)
Laia Raigal, Dr. study chair
Data Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Clinic Assessments, Survivorship Clinic Nurse Resource and Survivorship Clinic Dietitian Resource in people with Survivorship and Breast Cancer, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled in the clinic. (time frame: At the baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.