Clinical trial NCT04014309: Accessible Cancer Care to Enable Support for Survivors Programme
Official title: Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Survivorship
Breast Cancer
Gynecologic Cancer
Keywords: distress screening
supportive care
survivorship
health service
triage
breast cancer
gynecologic Cancer
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Cancer Centre, Singapore
First posted: 2019-07-10
Enrollment: 226
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this cluster randomized study, a cluster unit is defined as the clinic held by the individual oncologists who are treating eligible patients. The randomization schedule will allocate the cluster units (i.e. each oncologist and their clinic) in a 1:1 ratio to either the new supportive and survivorship care program or usual care arm. Therefore, all participants who received care from the same oncologist will have the same allocation.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of breast or gynaecological cancer ascertained by clinical documentation
* Newly diagnosed patients receiving subsequent follow-up care in NCCS
* Able to read and understand English or Chinese
* Capable of providing informed consent

Exclusion Criteria:

* Physically or mentally incapable of providing verbal / written consent
* Patients under active care by the palliative care team

Primary outcomes:
measure: Change in quality of life from baseline across all time points between the intervention and control study arm
timeFrame: Once at baseline and every 3 months for a period of 12 months
Secondary outcomes:
measure: Proportion of patients who achieve a clinically significant improvement or deterioration in quality of life between the intervention and control study arm
timeFrame: 12 months post recruitment
measure: Physical and psychological symptom distress levels between the intervention and control study arm
timeFrame: Once at baseline and every 3 months for a period of 12 months
measure: Quality of life of caregivers providing care to patients in the intervention study arm
timeFrame: 12 months post recruitment
measure: Fatigue levels
timeFrame: Baseline and 3 months after
measure: Severity of neuropathy
timeFrame: Baseline and 3 months after
measure: Cognitive function
timeFrame: Baseline and 3 months after
measure: Severity of arthralgia
timeFrame: Baseline and 3 months after
measure: Satisfaction levels of patients in the intervention study arm
timeFrame: 12 months post recruitment
measure: Work productivity
timeFrame: 9 months and 12 months post recruitment
measure: Extent of healthcare resource utilization
timeFrame: Throughout 12 months of follow-up period
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National University of Singapore, National Cancer Centre Singapore
name: Alexandre Chan, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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