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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |