The LYSA (Linking You to Support and Advice) Trial

University College Cork (UCC)

Status: Active, not recruiting

Conditions: Endometrial Cancer; Breast Cancer; Survivorship; Cervical Cancer

Treatments: Other: Survivorship Clinic Nurse Resource; Other: Survivorship Clinic Assessments; Other: Survivorship Clinic Dietitian Resource

Study type: Interventional

Funder types: Other

Identifiers

NCT05035173

WHI19CON (Other Grant/Funding Number)

R19258

BCR-2019-09-ICS-UCC (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention Arm

Experimental group

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).

Treatment:

Other: Survivorship Clinic Dietitian Resource

Other: Survivorship Clinic Assessments

Other: Survivorship Clinic Nurse Resource

Control Arm

Active Comparator group

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.

Treatment:

Other: Survivorship Clinic Assessments