Breast Cancer Clinical Trial
Official title:
Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients
In Singapore, cancer patients are not consistently assessed for unmet survivorship care needs
and systematically identified for subsequent referral to useful care services. To address
this gap, a preliminary multidisciplinary program is developed to (i) routinely screen and
identify cancer patients with high distress levels, and (ii) provide appropriate care
referrals after a systematic review by a supportive care nurse.
This study hypothesized that breast and gynecological cancer patients receiving timely
screening for distress and appropriate supportive care services will report better
improvement in quality of life as compared to non-recipients under usual care. This pilot
study then aims to evaluate:
(i) The effectiveness of the program on a patient level in improving the quality of life and
the symptom burden of patients requiring further supportive services.
(ii) The feasibility of the program's implementation on a health-system level among breast
and gynaecological cancer patients in the outpatient oncology clinics at a specialty cancer
centre.
A cluster randomized controlled trial will be conducted at the National Cancer Centre
Singapore (NCCS) over a period of 2 years. Eligible participants and their caregivers where
applicable will be recruited and followed-up for a period of 12 months. Patients in the
intervention arm will receive routine distress screening and referral to a supportive care
nurse service where necessary; whereas patients in the control arm will receive usual care.
Patients' quality of life will be assessed by the European Organization for Research and
Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and compared longitudinally
between both study arms at a 3-months interval. Additionally, physical and psychological
symptom distress levels will be compared using the Rotterdam Symptom Checklist (RSCL).
For patients who receive symptom-specific services, additional questionnaires will be
completed before and after they have received the service. They include the following:
Multi-dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for fatigue, Patient
Neurotoxicity Questionnaire (PNQ) for neuropathy, Functional Assessment of Cancer
Therapy-Cognitive Function (FACT-Cog v3.0) for cognitive function, and Patient-Reported
Arthralgia Inventory (PRAI) for arthralgia.
An economic evaluation will be conducted using healthcare resource utilization and cost data
gathered from health records and surveys including the Work Productivity and Activity
Impairment (WPAI) questionnaire. Process outcomes of the program delivery will also be
obtained to assess its feasibility by monitoring the referral patterns to supportive care
nurse and adherence to screening or appointments. Lastly, patient satisfaction and clinicians
acceptability of the program will be assessed via questionnaires.
Results from this study on the program's feasibility and effectiveness among breast and
gynecological cancer patients are crucial to highlight potential implementation barriers and
utility for patients before extending to other cancer types. Furthermore, results can shed a
light on the program's scalability for future integration into routine care. This compelling
initiative will contribute to the institution of integrated and coordinated rehabilitative
and specialized clinics services to address supportive and survivorship needs of cancer
patients across the continuum in the long run.
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