Clinical trial NCT05035173: The LYSA (Linking You to Support and Advice) Trial
Official title: Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Dietitian Intervention
Nurse intervention
Symptom Management
Quality of Life
Self-care Agency
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Irish Cancer Society
name: Breakthrough Cancer Research
name: Cancer Research@UCC
name: Cancer Trials Cork
name: Clinical Research Facilites - Cork (CRF-C)
name: Cork University Hospital
name: Enhancing Cancer Awareness and Survivorship Programmes (ECASP)
First posted: 2021-09-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients enrolled in the clinic.
timeFrame: At the baseline
measure: Reasons for not enrolling to the study.
timeFrame: At the baseline
measure: Reasons for not completing the intervention (drop out).
timeFrame: During the study period (12-month)
measure: Percentage of adherence to the intervention completing ePROs surveys
timeFrame: Baseline, each 2 months till end intervention (12 months)
measure: Number of patients who partake in healthcare professional consultations after ePRO data triggers.
timeFrame: Baseline, each 2 months till end intervention (12 months)
measure: Average consultation time in the Womens Survivorship Clinic.
timeFrame: Baseline, each 2 months till end intervention (12 months)
Secondary outcomes:
measure: Change from Baseline in cancer-related symptoms scores assessed by Patient-Reported Outcomes.
timeFrame: Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10
measure: Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) scores assessed by European Organization for the Research and Treatment of Cancer (EORTC).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: 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).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: 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).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: 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).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in EuroQol 5-Level 5-Dimensions quality-adjusted life-year version (EQ-5D-5L-QALY) scores.
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in Appraisal Self-Care Agency-R scores (15 items).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in adjuvant endocrine therapy medication adherence.
timeFrame: Both arms at the baseline and at the end of the study (12-month); intervention arm month 2, 4, 6, 8, 10
measure: Assessment of Usability and Satisfaction of the survivorship clinic will be assessed by the Usability and Satisfaction Scale (Lewis, 1995).
timeFrame: Intervention arms at the end of the intervention (12-month)
measure: Experience and opinions from patients, HCP and wider stakeholders about the Women Survivorship Study including the clinic.
timeFrame: Intervention arms at the end of the intervention (12-month)
measure: Number of resources used by each patient with a cancer related symptom to evaluate the economic impact.
timeFrame: Both arms at the end of the intervention (12-month)
measure: Change from Baseline in Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: 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).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in BMI scores.
timeFrame: Both arms at the baseline and at the end of the intervention (12-month); intervention arm each 2 months
measure: Change from Baseline in Lean Body Mass (LBM) scores.
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in waist circumference scores.
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in Segmental Body Composition scores assessed measured by Body Composition Monitor bioimpedance spectroscopy (BIS).
timeFrame: Both arms at the baseline and at the end of the intervention (12-month).
measure: Change from Baseline in muscle strength scores on handgrip measurements.
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
measure: Change from Baseline in Nutritional risk scores assessed by the Malnutrition Screening Tool (MST). The higher the score, the higher risk of malnutrition.
timeFrame: Both arms at the baseline and at the end of the intervention (12-month)
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: Research Support Officer Clinical (Nurse Manager)
name: Kate O Connell, Ms.
role: STUDY_CHAIR
affiliation: Data Manager
name: Laia Raigal, Dr.
role: STUDY_CHAIR
References:
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.