Accessible Cancer Care to Enable Support for Survivors Programme (ACCESS)

November 27, 2019 updated by: Alexandre Chan, National University, Singapore

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexandre Chan, PharmD
  • Phone Number: 65-65167814
  • Email: phaac@nus.edu.sg

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive and survivorship care program
Routine distress screening will be conducted using the Distress Thermometer (DT) and an accompanying problem list. Participants will complete the screening tool before their consults with oncologists and the results will be stored in their medical records. During the consult, oncologists will review the DT scores and problem list with each participant to provide the corresponding educational materials, advice or referrals. Highly distressed participants may be referred by oncologists to the supportive care nurses (SCN) for further triage and review.
Other: Supportive and survivorship care program
Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.
Placebo Comparator: Usual care
No routine distress screening will be performed.
Other: Usual care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life from baseline across all time points between the intervention and control study arm
Time Frame: Once at baseline and every 3 months for a period of 12 months
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) assesses cancer patients' health-related quality of life for the past week. The global quality of life status scale will be used and it is scored from 0 to 100 where a higher score is indicative of better functioning.
Once at baseline and every 3 months for a period of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who achieve a clinically significant improvement or deterioration in quality of life between the intervention and control study arm
Time Frame: 12 months post recruitment
Difference in quality of life scores assessed by EORTC QLQ-C30 will be tabulated for each patient. For each subscale, a medium improvement and deterioration in the longitudinal scores are defined and the proportion of patients who achieved the improvement or deterioration will be tabulated.
12 months post recruitment
Physical and psychological symptom distress levels between the intervention and control study arm
Time Frame: Once at baseline and every 3 months for a period of 12 months
The physical domain of the Rotterdam Symptom Checklist (RSCL) comprises of 23 items and the psychological distress domain comprises of 7 items. Patients will rate each item/ symptom on a 4-point Likert scale ("not at all", "a little", "quite a bit" and "very much"). A higher domain score indicates higher distress levels and symptom burden.
Once at baseline and every 3 months for a period of 12 months
Quality of life of caregivers providing care to patients in the intervention study arm
Time Frame: 12 months post recruitment
The Singapore Caregiver Quality of Life Scale (SCQOLS) is a validated, multi-domain quality of life measurement scale. The five domains consist of: physical well-being, mental well-being, experience and meaning, impact on daily living and financial well-being. A total QOL score will also be tabulated. A higher score in each domain and the total score will indicate better performance and quality of life respectively.
12 months post recruitment
Fatigue levels
Time Frame: Baseline and 3 months after
The Multi-dimensional Fatigue Symptom Inventory-Short Form (MSFI-SF) consists of 30 items to assess 5 dimensions of fatigue: physical, general, emotional, mental and vigour26. Respondent will rate each statement on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely").
Baseline and 3 months after
Severity of neuropathy
Time Frame: Baseline and 3 months after
The Patient Neurotoxicity Questionnaire (PNQ) is a self-administered instrument designed for patient-based assessment of chemotherapy-induced peripheral neuropathy. It consists of two items that identify the incidence and severity of the sensory and motor disturbances. The severity will be rated from grade A to E with increasing severity. Also, patient will indicate the daily living activities that were interfered by chemotherapy treatment.
Baseline and 3 months after
Cognitive function
Time Frame: Baseline and 3 months after
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog v3.0) consists of 37 items to assess subjective cognitive function in the following 6 domains: memory, concentration, mental acuity, verbal fluency, functional interference and multitasking. Two other subscales included are "noticeability" of cognitive changes and "effect of perceived cognitive impairment on quality of life". Respondent will rate the frequency of occurrence of each item in the past week on a 5-point Likert scale from 0 ("never") to 4 ("several times a day"). A higher domain or subscale score indicating better perceived cognitive functioning.
Baseline and 3 months after
Severity of arthralgia
Time Frame: Baseline and 3 months after
The Patient-Reported Arthralgia Inventory (PRAI) consists of 16 items to measure arthralgia severity in 8 joint pair groups. Respondent will rate the pain severity at each joint for the past week using a 11-point Likert scale from 0 ("none") to 10 ("as bad as you can imagine"). The total score will be a sum of ratings for all items and range from 0 to 160 where a higher score indicates greater arthralgia severity.
Baseline and 3 months after
Satisfaction levels of patients in the intervention study arm
Time Frame: 12 months post recruitment
Patient acceptability questionnaire is adapted from the literature. Patients will rate the various processes in the program based on perceptions of the screening process, consult with supportive care nurse to discuss problems and the adequacy of information provision.
12 months post recruitment
Work productivity
Time Frame: 9 months and 12 months post recruitment
The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-item patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to a specific health condition (cancer status) for the past week.
9 months and 12 months post recruitment
Extent of healthcare resource utilization
Time Frame: Throughout 12 months of follow-up period
Information on outpatient visits, hospitalizations, and healthcare-related resources will be extracted from participants' medical and billing records.
Throughout 12 months of follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Collaborators

National Cancer Centre, Singapore

Investigators

  • Principal Investigator: Alexandre Chan, PharmD, National University of Singapore, National Cancer Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref. No: 2019/2090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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