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The Stop Cancer PAIN Trial: A guideline implementation study

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000064505
Enrollment
800
Registered
2015-01-23
Start date
2015-08-10
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026