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

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ClinicalTrials.gov Identifier: NCT04014309
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Cancer Centre, Singapore
Information provided by (Responsible Party):
Alexandre Chan, National University, Singapore

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.


Condition or disease Intervention/treatment Phase
Survivorship Breast Cancer Gynecologic Cancer Other: Supportive and survivorship care program Other: Usual care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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").

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014309


Contacts
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Contact: Alexandre Chan, PharmD 65-65167814 phaac@nus.edu.sg

Locations
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Singapore
National Cancer Centre Singapore Not yet recruiting
Singapore, Singapore
Contact: Alexandre Chan, Pharm.D    65-64368139    Alexandre.Chan@nccs.com.sg   
Sponsors and Collaborators
National University, Singapore
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Alexandre Chan, PharmD National University of Singapore, National Cancer Centre Singapore

Publications:

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Responsible Party: Alexandre Chan, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT04014309     History of Changes
Other Study ID Numbers: CIRB Ref. No: 2019/2090
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandre Chan, National University, Singapore:
distress screening
supportive care
survivorship
health service
triage
breast cancer
gynecologic Cancer