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The LYSA (Linking You to Support and Advice) Trial (LYSA)

Primary Purpose

Survivorship, Breast Cancer, Cervical Cancer

Status
Active
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Survivorship Clinic Assessments
Survivorship Clinic Nurse Resource
Survivorship Clinic Dietitian Resource
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Survivorship focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women aged > or = 18 years.
  2. Ability to read and understand English.
  3. Access to internet.

  4. 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

Exclusion Criteria:

  1. Patients who are not treated with curative intent as above.
  2. Patients with premalignant disease.
  3. Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol.
  4. 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.

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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.
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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).
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.

Full Information

First Posted
April 26, 2021
Last Updated
October 26, 2022
Sponsor
University College Cork
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)
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1. Study Identification

Unique Protocol Identification Number
NCT05035173
Brief Title
The LYSA (Linking You to Support and Advice) Trial
Acronym
LYSA
Official Title
Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork
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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Dietitian Intervention, Nurse intervention, Symptom Management, Quality of Life, Self-care Agency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Survivorship Clinic Assessments
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Survivorship Clinic Nurse Resource
Other Intervention Name(s)
Complex Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Survivorship Clinic Dietitian Resource
Other Intervention Name(s)
Complex Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients enrolled in the clinic.
Description
Number of patients who were eligible and accepted to participate in the study. This will be recorded in the electronic Case Report Forms (eCRF).
Time Frame
At the baseline
Title
Reasons for not enrolling to the study.
Description
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).
Time Frame
At the baseline
Title
Reasons for not completing the intervention (drop out).
Description
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).
Time Frame
During the study period (12-month)
Title
Percentage of adherence to the intervention completing ePROs surveys
Description
Number of enrolled patients who complete the baseline and follow-up ePRO surveys. This will be recorded in the ePROs.
Time Frame
Baseline, each 2 months till end intervention (12 months)
Title
Number of patients who partake in healthcare professional consultations after ePRO data triggers.
Description
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).
Time Frame
Baseline, each 2 months till end intervention (12 months)
Title
Average consultation time in the Womens Survivorship Clinic.
Description
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).
Time Frame
Baseline, each 2 months till end intervention (12 months)
Secondary Outcome Measure Information:
Title
Change from Baseline in cancer-related symptoms scores assessed by Patient-Reported Outcomes.
Description
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.
Time Frame
Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10
Title
Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
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).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
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).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
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).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in EuroQol 5-Level 5-Dimensions quality-adjusted life-year version (EQ-5D-5L-QALY) scores.
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in Appraisal Self-Care Agency-R scores (15 items).
Description
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
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in adjuvant endocrine therapy medication adherence.
Description
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.
Time Frame
Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10
Title
Assessment of Usability and Satisfaction of the survivorship clinic will be assessed by the Usability and Satisfaction Scale (Lewis, 1995).
Description
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.
Time Frame
Intervention arms at the end of the intervention (12-month)
Title
Experience and opinions from patients, HCP and wider stakeholders about the Women Survivorship Study including the clinic.
Description
Qualitative data collection will be done via Interviews/Focus Groups at the end of the intervention.
Time Frame
Intervention arms at the end of the intervention (12-month)
Title
Number of resources used by each patient with a cancer related symptom to evaluate the economic impact.
Description
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.
Time Frame
Both arms at the end of the intervention (12-month)
Title
Change from Baseline in Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
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).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in BMI scores.
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month); intervention arm each 2 months
Title
Change from Baseline in Lean Body Mass (LBM) scores.
Description
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).
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in waist circumference scores.
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in Segmental Body Composition scores assessed measured by Body Composition Monitor bioimpedance spectroscopy (BIS).
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month).
Title
Change from Baseline in muscle strength scores on handgrip measurements.
Description
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).
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)
Title
Change from Baseline in Nutritional risk scores assessed by the Malnutrition Screening Tool (MST). The higher the score, the higher risk of malnutrition.
Description
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.
Time Frame
Both arms at the baseline and at the end of the intervention (12-month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate O Connell, Ms.
Organizational Affiliation
Research Support Officer Clinical (Nurse Manager)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laia Raigal, Dr.
Organizational Affiliation
Data Manager
Official's Role
Study Chair
Facility Information:
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12 DFK4
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not applicable at the moment.
Citations:
PubMed Identifier
36357934
Citation
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. Erratum In: Pilot Feasibility Stud. 2022 Dec 12;8(1):255.
Results Reference
derived
Links:
URL
https://www.cancer.ie/cancer-research/about-our-cancer-research/our-cancer-research-networks/womens-health-initiative
Description
Women's Health Initiative - Cancer survivorship support for women
URL
https://www.breakthroughcancerresearch.ie/research/womens-cancer-survivorship/
Description
Women's Cancer Survivorship: Supporting And Innovating For Change
URL
https://www.youtube.com/watch?v=iD5Zdxfm14A
Description
Short video about the Women's Health Initiative pilot clinic in Cork

Learn more about this trial

The LYSA (Linking You to Support and Advice) Trial

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