SurvivorshipACCESSNCT04014309
Accessible Cancer Care to Enable Support for Survivors Programme
A study testing Supportive and survivorship care program in people with Survivorship and Breast Cancer, run by National University of Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Survivorship, Breast Cancer, Gynecologic Cancer
- What is being tested?
- Supportive and survivorship care program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2019to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Physically or mentally incapable of providing verbal / written consent
- Patients under active care by the palliative care team
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore
Alexandre Chan, Pharm.D, 65-64368139, Alexandre.Chan@nccs.com.sg
About this study
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:
Read more
(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.
Read the 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.
- Conditions
- Survivorship, Breast Cancer, Gynecologic Cancer
- Being tested
- Supportive and survivorship care program, Usual care
- Keywords
- distress screening, supportive care, survivorship, health service, triage, breast cancer, gynecologic Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive and survivorship care programOther
Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Supportive and survivorship care program | Experimental | 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. Receives: Other: Supportive and survivorship care program |
| Usual care | Placebo comparator | No routine distress screening will be performed. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life from baseline across all time points between the intervention and control study arm
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.
Measured: Once at baseline and every 3 months for a period of 12 months
Secondary outcomes (10)
Proportion of patients who achieve a clinically significant improvement or deterioration in quality of life between the intervention and control study arm
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.
Measured: 12 months post recruitment
Physical and psychological symptom distress levels between the intervention and control study arm
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.
Measured: 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
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.
Measured: 12 months post recruitment
Fatigue levels
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").
Measured: Baseline and 3 months after
Severity of neuropathy
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.
Measured: Baseline and 3 months after
Cognitive function
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.
Measured: Baseline and 3 months after
Severity of arthralgia
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.
Measured: Baseline and 3 months after
Satisfaction levels of patients in the intervention study arm
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.
Measured: 12 months post recruitment
Work productivity
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.
Measured: 9 months and 12 months post recruitment
Extent of healthcare resource utilization
Information on outpatient visits, hospitalizations, and healthcare-related resources will be extracted from participants' medical and billing records.
Measured: Throughout 12 months of follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Oct 2019
- Primary completionApr 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre, Singapore
- Responsible party
- Principal investigator, Alexandre Chan, National University of Singapore
- Investigators
- Alexandre Chan, PharmD, Principal investigator, National University of Singapore, National Cancer Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014309
- Sponsor's protocol ID
- CIRB Ref. No: 2019/2090
- Acronym
- ACCESS
- Status last verified
- Nov 2019
- First submitted
- 4 Jul 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loh KW, Ng T, Choo SP, Saw HM, Mahendran R, Tan C, Chang GCY, Ong YJ, Yee ACP, Chan A, Soo KC. Cancer Supportive and Survivorship Care in Singapore: Current Challenges and Future Outlook. J Glob Oncol. 2018 Sep;4:1-8. doi: 10.1200/JGO.17.00117.
PubMed 30241247Tan ML, Idris DB, Teo LW, Loh SY, Seow GC, Chia YY, Tin AS. Validation of EORTC QLQ-C30 and QLQ-BR23 questionnaires in the measurement of quality of life of breast cancer patients in Singapore. Asia Pac J Oncol Nurs. 2014 Apr-Jun;1(1):22-32. doi: 10.4103/2347-5625.135817.
PubMed 27981079de Haes JC, van Knippenberg FC, Neijt JP. Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer. 1990 Dec;62(6):1034-8. doi: 10.1038/bjc.1990.434.
PubMed 2257209Lim HA, Mahendran R, Chua J, Peh CX, Lim SE, Kua EH. The Distress Thermometer as an ultra-short screening tool: a first validation study for mixed-cancer outpatients in Singapore. Compr Psychiatry. 2014 May;55(4):1055-62. doi: 10.1016/j.comppsych.2014.01.008. Epub 2014 Jan 18.
PubMed 24556515Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Cheung YB, Neo SHS, Teo I, Yang GM, Lee GL, Thumboo J, Chia JWK, Koh ARX, Qu DLM, Che WWL, Lau A, Wee HL. Development and evaluation of a quality of life measurement scale in English and Chinese for family caregivers of patients with advanced cancers. Health Qual Life Outcomes. 2019 Feb 14;17(1):35. doi: 10.1186/s12955-019-1108-y.
PubMed 30764839Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
PubMed 10146874Chan A, Lew C, Wang XJ, Ng T, Chae JW, Yeo HL, Shwe M, Gan YX. Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore. Health Qual Life Outcomes. 2018 Jan 19;16(1):20. doi: 10.1186/s12955-018-0846-6.
PubMed 29351803Kuroi K, Shimozuma K, Ohashi Y, Hisamatsu K, Masuda N, Takeuchi A, Aranishi T, Morita S, Ohsumi S, Hausheer FH. Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study). Support Care Cancer. 2009 Aug;17(8):1071-80. doi: 10.1007/s00520-008-0550-x. Epub 2008 Dec 17.
PubMed 19089463Castel LD, Wallston KA, Saville BR, Alvarez JR, Shields BD, Feurer ID, Cella D. Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia. Patient Relat Outcome Meas. 2015 Jul 28;6:205-14. doi: 10.2147/PROM.S47997. eCollection 2015.
PubMed 26251635van Nuenen FM, Donofrio SM, Tuinman MA, van de Wiel HB, Hoekstra-Weebers JE. Feasibility of implementing the 'Screening for Distress and Referral Need' process in 23 Dutch hospitals. Support Care Cancer. 2017 Jan;25(1):103-110. doi: 10.1007/s00520-016-3387-8. Epub 2016 Aug 26.
PubMed 27565789Ristevski E, Regan M, Jones R, Breen S, Batson A, McGrail MR. Cancer patient and clinician acceptability and feasibility of a supportive care screening and referral process. Health Expect. 2015 Jun;18(3):406-18. doi: 10.1111/hex.12045. Epub 2013 Jan 31.
PubMed 23369083Cocks K, King MT, Velikova G, de Castro G Jr, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur J Cancer. 2012 Jul;48(11):1713-21. doi: 10.1016/j.ejca.2012.02.059. Epub 2012 Mar 12.
PubMed 22418017Ke Y, Neo PSH, Yang GM, Neo SH, Tan YY, Tan YP, Ramalingam MB, Loh KW, Quah DSC, Chew L, Si PEH, Chan RJ, Hwang WYK, Chan A. Impact of a Multidisciplinary Supportive Care Model Using Distress Screening at an Asian Ambulatory Cancer Center: A Cluster Randomized Controlled Trial. JCO Oncol Pract. 2024 Sep;20(9):1207-1218. doi: 10.1200/OP.23.00505. Epub 2024 Jun 5.
PubMed 38838278
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients
- ClinicalTrials.gov ID
- NCT04014309
- Acronym / sponsor ID
- ACCESS / CIRB Ref. No: 2019/2090
- Conditions
- Survivorship, Breast Cancer, Gynecologic Cancer
- Keywords
- distress screening, supportive care, survivorship, health service, triage, breast cancer, gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National Cancer Centre, Singapore
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supportive and survivorship care program | Experimental | Other: Supportive and survivorship care programRoutine 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. |
| Usual care | Placebo comparator | Other: Usual careNo routine distress screening will be performed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Physically or mentally incapable of providing verbal / written consent
- Patients under active care by the palliative care team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive and survivorship care programProvision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service. | Other | Supportive and survivorship care program |
| Usual careUsual care | Other | Usual care |
Primary outcome
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.
10 secondary outcomes
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
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
Quality of life of caregivers providing care to patients in the intervention study arm
Time frame: 12 months post recruitment
Fatigue levels
Time frame: Baseline and 3 months after
Severity of neuropathy
Time frame: Baseline and 3 months after
Cognitive function
Time frame: Baseline and 3 months after
Severity of arthralgia
Time frame: Baseline and 3 months after
Satisfaction levels of patients in the intervention study arm
Time frame: 12 months post recruitment
Work productivity
Time frame: 9 months and 12 months post recruitment
Extent of healthcare resource utilization
Time frame: Throughout 12 months of follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 30241247Loh KW, Ng T, Choo SP, Saw HM, Mahendran R, Tan C, Chang GCY, Ong YJ, Yee ACP, Chan A, Soo KC. Cancer Supportive and Survivorship Care in Singapore: Current Challenges and Future Outlook. J Glob Oncol. 2018 Sep;4:1-8. doi: 10.1200/JGO.17.00117.
- Background: PubMed 27981079Tan ML, Idris DB, Teo LW, Loh SY, Seow GC, Chia YY, Tin AS. Validation of EORTC QLQ-C30 and QLQ-BR23 questionnaires in the measurement of quality of life of breast cancer patients in Singapore. Asia Pac J Oncol Nurs. 2014 Apr-Jun;1(1):22-32. doi: 10.4103/2347-5625.135817.
- Background: PubMed 2257209de Haes JC, van Knippenberg FC, Neijt JP. Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer. 1990 Dec;62(6):1034-8. doi: 10.1038/bjc.1990.434.
- Background: PubMed 24556515Lim HA, Mahendran R, Chua J, Peh CX, Lim SE, Kua EH. The Distress Thermometer as an ultra-short screening tool: a first validation study for mixed-cancer outpatients in Singapore. Compr Psychiatry. 2014 May;55(4):1055-62. doi: 10.1016/j.comppsych.2014.01.008. Epub 2014 Jan 18.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 30764839Cheung YB, Neo SHS, Teo I, Yang GM, Lee GL, Thumboo J, Chia JWK, Koh ARX, Qu DLM, Che WWL, Lau A, Wee HL. Development and evaluation of a quality of life measurement scale in English and Chinese for family caregivers of patients with advanced cancers. Health Qual Life Outcomes. 2019 Feb 14;17(1):35. doi: 10.1186/s12955-019-1108-y.
- Background: PubMed 10146874Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
- Background: PubMed 29351803Chan A, Lew C, Wang XJ, Ng T, Chae JW, Yeo HL, Shwe M, Gan YX. Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore. Health Qual Life Outcomes. 2018 Jan 19;16(1):20. doi: 10.1186/s12955-018-0846-6.
- Background: PubMed 19089463Kuroi K, Shimozuma K, Ohashi Y, Hisamatsu K, Masuda N, Takeuchi A, Aranishi T, Morita S, Ohsumi S, Hausheer FH. Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study). Support Care Cancer. 2009 Aug;17(8):1071-80. doi: 10.1007/s00520-008-0550-x. Epub 2008 Dec 17.
- Background: PubMed 26251635Castel LD, Wallston KA, Saville BR, Alvarez JR, Shields BD, Feurer ID, Cella D. Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia. Patient Relat Outcome Meas. 2015 Jul 28;6:205-14. doi: 10.2147/PROM.S47997. eCollection 2015.
- Background: PubMed 27565789van Nuenen FM, Donofrio SM, Tuinman MA, van de Wiel HB, Hoekstra-Weebers JE. Feasibility of implementing the 'Screening for Distress and Referral Need' process in 23 Dutch hospitals. Support Care Cancer. 2017 Jan;25(1):103-110. doi: 10.1007/s00520-016-3387-8. Epub 2016 Aug 26.
- Background: PubMed 23369083Ristevski E, Regan M, Jones R, Breen S, Batson A, McGrail MR. Cancer patient and clinician acceptability and feasibility of a supportive care screening and referral process. Health Expect. 2015 Jun;18(3):406-18. doi: 10.1111/hex.12045. Epub 2013 Jan 31.
- Individual participant dataSharing planned: No
Related trials for Survivorship
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
Recruiting
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Chan, PharmD principal investigator
National University of Singapore, National Cancer Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive and survivorship care program in people with Survivorship and Breast Cancer, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Chan, PharmD (65-65167814, phaac@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014309, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.