Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College Cork
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Reasons for not completing the intervention (drop out).
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention Arm
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).
Intervention: Survivorship Clinic Assessments (Other)
Intervention Arm
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).
Intervention: Survivorship Clinic Nurse Resource (Other)
Intervention Arm
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).
Intervention: Survivorship Clinic Dietitian Resource (Other)
Control Arm
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: Survivorship Clinic Assessments (Other)
Outcomes
Primary Outcomes
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).
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).
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).
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 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).
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).
Secondary Outcomes
- 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) 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 EuroQol 5-Level 5-Dimensions quality-adjusted life-year version (EQ-5D-5L-QALY) scores.(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).(Both arms at the baseline and at the end of the intervention (12-month))
- 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)
- Number of resources used by each patient with a cancer related symptom to evaluate the economic impact.(Both arms at the end of the intervention (12-month))
- Change from Baseline in Lean Body Mass (LBM) scores.(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))
- Assessment of Usability and Satisfaction of the survivorship clinic will be assessed by the Usability and Satisfaction Scale (Lewis, 1995).(Intervention arms at the end of the intervention (12-month))
- Change from Baseline in BMI scores.(Both arms at the baseline and at the end of the intervention (12-month); intervention arm each 2 months)
- Change from Baseline in waist circumference scores.(Both arms at the baseline and at the end of the intervention (12-month))
- Change from Baseline in muscle strength scores on handgrip measurements.(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.(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) 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 Appraisal Self-Care Agency-R scores (15 items).(Both arms at the baseline and 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.(Intervention arms 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).(Both arms at the baseline and at the end of the intervention (12-month).)
- Change from Baseline in adjuvant endocrine therapy medication adherence.(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 Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ).(Both arms at the baseline and at the end of the intervention (12-month))
Investigators
Roisin Connolly
Professor
University College Cork