Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000064505
Ethics application status
Approved
Date submitted
24/11/2014
Date registered
23/01/2015
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Stop Cancer PAIN Trial: A guideline implementation study
Scientific title
A pragmatic stepped wedge cluster randomised controlled trial of guidelines and screening with implementation strategies versus guidelines and screening alone for cancer pain in adult outpatients attending oncology and palliative care services
Secondary ID [1] 285472 0
Nil
Universal Trial Number (UTN)
U1111-1164-4649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer pain 293249 0
Condition category
Condition code
Cancer 293519 293519 0 0
Any cancer
Public Health 294094 294094 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A system for screening for cancer pain and feeding back results to the medical team to inform treatment + strategies to implement evidence-based guidelines for screening, assessment and management of cancer pain as follows:

1. An audit tool will be administered twice over a 3 month period to enable centres to monitor how well they are implementing core standards of cancer pain assessment and management.
2. A toolkit for identifying barriers and facilitators to practice change and implementing strategies to overcome these;
3. QStream online health professional education to test and consolidate knowledge of cancer pain assessment and management as recommended in the 'Cancer pain management in adults' guidelines available from the Cancer Council Australia Cancer Guideline Wiki;
4. Patient-held resources to ensure management remains centred on individual patient needs, support patient-health professional communication and coordination and help patients advocate for evidence-based, person-centred care. Patients and caregivers will be offered brief training in how to use the resources by a staff member at the centre.

Centres will be asked to implement the above strategies for a 4 month period and will be at liberty to continue them for as long as they wish afterwards.
Intervention code [1] 290408 0
Other interventions
Comparator / control treatment
A system for screening for cancer pain and feeding back results to the medical team to inform care for cancer pain according to local practice. The system will allow patients to report their pain and quality of life via touchscreen computer at each visit to the service whilst waiting to see their medical team. Results will be fed back to the medical team via print-out and/or email prior to the consultation.
Control group
Active

Outcomes
Primary outcome [1] 293335 0
Probability that patients screened as having moderate-severe worst pain (5+ on a 0-10 numerical rating scale [NRS]) will experience a clinically important improvement of 30%+ on the NRS.
Timepoint [1] 293335 0
1 week after screening positive for moderate-severe worst pain
Secondary outcome [1] 310814 0
Patient mean pain as measured on a 0-10 NRS
Timepoint [1] 310814 0
1, 2 and 4 weeks after screening positive for having clinically significant worst pain (2+ on 0-10 NRS)
Secondary outcome [2] 310815 0
Patient quality of life (QOL) as measured by the EORTC QLQ C15-PAL
Timepoint [2] 310815 0
1, 2 and 4 weeks after screening positive for having clinically significant worst pain
Secondary outcome [3] 310816 0
Carer experience, measured by the Carer Experience Scale (CES)
Timepoint [3] 310816 0
2 and 4 weeks after participating recipient of care screened positive for having moderate-severe worst pain
Secondary outcome [4] 311589 0
Patient empowerment, measured by the Health Education Impact Questionnaire (heiQ)
Timepoint [4] 311589 0
1, 2 and 4 weeks after screening positive for having clinically significant worst pain
Secondary outcome [5] 311590 0
Cost effectiveness, as measured by incremental cost per quality adjusted life year (QALY)
Timepoint [5] 311590 0
Period of 4 weeks since patient screened positive for clinically significant worst pain

Eligibility
Key inclusion criteria
Inclusion criteria for patients to be included in the primary endpoint will be: 1) attending a participating cancer or palliative care service as an outpatient during the study period; 2) having a diagnosis of cancer; 3) being able to self-complete a 0-10 NRS for severity of worst and average pain in English, Chinese, Italian, Greek, Vietnamese or Arabic; 4) choosing not to opt-out of being contacted 1 week later to complete the NRS over the telephone and giving verbal consent to do so when telephoned; 5) a score of moderate-severe (5+) on the NRS for worst pain.

Inclusion criteria for patients contributing to secondary outcomes will be meeting inclusion criteria 1, 2, 3 and 4 above and also: 5) a score 2+ on the NRS for worst pain; 6) providing written informed consent in English; 7) having spoken and written English proficiency sufficient to complete study measures.

Inclusion criteria for carers will be: 1) being identified by a patient who has given written informed consent to participate in the study as providing them with substantial emotional and practical support in an unpaid capacity; 2) providing written informed consent; 3) having spoken and written English proficiency sufficient to complete a brief survey and/or interview.

Inclusion criteria for centre staff will be: 1) being employed on a permanent basis either full- or part-time at a participating oncology or palliative care service in a role that provides clinical care to patients with cancer pain or front desk, client-focused administrative support; 2) providing written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients

- Participation at another centre taking part in the trial or at the same centre at a previous time when it was in the control arm
- Documented as having cognitive impairment that would preclude capacity to give informed consent

Unpaid carers

- Patient for whom they provide care is not participating in any secondary outcome components

Centre Staff

- Casual or agency staff

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
This trial uses a stepped wedge cluster randomised controlled design, which means that the unit of randomisation is at the outpatient service rather than patient. All centres will start in the control arm and then transition to intervention; it is the order in which they transition that will be randomised. Patients will be automatically assigned to the arm which the service is in at the time that they present.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2015
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 3181 0
Westmead Hospital - Westmead
Recruitment hospital [2] 3209 0
St George Hospital - Kogarah
Recruitment hospital [3] 4048 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 8224 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 8225 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 8501 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 8502 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 16594 0
3000 - Melbourne
Recruitment postcode(s) [2] 16595 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 290284 0
Charities/Societies/Foundations
Name [1] 290284 0
National Breast Cancer Foundation
Country [1] 290284 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Room 205
Edward Ford Building A27
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 288996 0
None
Name [1] 288996 0
Address [1] 288996 0
Country [1] 288996 0
Other collaborator category [1] 278250 0
Other Collaborative groups
Name [1] 278250 0
Improving Palliative Care through Clinical Trials (ImPaCCT)
Address [1] 278250 0
UTS Faculty of Health,
Building 10 Level 7,
235 Jones St,
Ultimo
NSW 2007
Country [1] 278250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291781 0
South Western Sydney Local Health District
Ethics committee address [1] 291781 0
Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 291781 0
Australia
Date submitted for ethics approval [1] 291781 0
27/10/2014
Approval date [1] 291781 0
10/12/2014
Ethics approval number [1] 291781 0
HREC/14/LPOOL/479

Summary
Brief summary
This study will evaluate strategies to implement evidence-based guidelines for screening, assessment and management of cancer pain in adult outpatients presenting at oncology and palliative care services.

Who is it for?

You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with any cancer and are attending a participating cancer centre as an outpatient.

Study details

All centres will start in the control arm and transition to intervention arm, but the order in which they transition will be allocated randomly (i.e. by chance). The control arm will receive screening for cancer pain with feedback to medical team to inform treatment and care according to local practice. The intervention includes the addition of strategies to implement evidence-based guidelines for screening, assessment and management of cancer pain. Strategies will include: An audit tool to enable centres to monitor how well they are implementing core standards of cancer pain assessment and management; a toolkit for identifying barriers and facilitators to practice change and implementing strategies to overcome these; QStream online health professional education to test and consolidate knowledge of cancer pain assessment and management; patient-held resources to ensure management remains centred on individual patient needs, support patient-health professional communication and coordination and help patients advocate for evidence-based, person-centred care.

The study will compare a time before the strategies are introduced with the time when they are being used to see if there is a difference in the probability of a clinically important reduction in pain for patients with moderate-severe pain. It will also test the effects of the strategies on patient quality of life and empowerment, carer experience, and cost-effectiveness of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52002 0
Prof Melanie Lovell
Address 52002 0
Greenwich Hospital
Pallister House
97-115 River Road
GREENWICH
NSW 2065
Country 52002 0
Australia
Phone 52002 0
+612 9903 8333
Fax 52002 0
Email 52002 0
[email protected]
Contact person for public queries
Name 52003 0
Alison Read
Address 52003 0
University of Technology Sydney (UTS), Faculty of Health, Building 10, Level 7, 235-253 Jones St, Ultimo, NSW 2007
Country 52003 0
Australia
Phone 52003 0
+612 9514 4858
Fax 52003 0
+61 2 9514 4474
Email 52003 0
[email protected]
Contact person for scientific queries
Name 52004 0
Alison Read
Address 52004 0
University of Technology Sydney (UTS), Faculty of Health, Building 10, Level 7, 235-253 Jones St, Ultimo, NSW 2007
Country 52004 0
Australia
Phone 52004 0
+612 9514 4858
Fax 52004 0
+61 2 9514 4474
Email 52004 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving the system for managing cancer pain.2015https://dx.doi.org/10.1111/imj.12677
EmbaseProtocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial.2018https://dx.doi.org/10.1186/s12913-018-3318-0
EmbaseTreatment patterns and out-of-hospital healthcare resource utilisation by patients with advanced cancer living with pain: An analysis from the Stop Cancer PAIN trial.2023https://dx.doi.org/10.1371/journal.pone.0282465
N.B. These documents automatically identified may not have been verified by the study sponsor.