The Stop Cancer PAIN Trial: A guideline implementation study

Not Applicable

Recruiting

• Conditions: Cancer pain; Cancer - Any cancer; Public Health - Health service research

• Registration Number: ACTRN12615000064505
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[1 week after screening positive for moderate-severe worst pain]

Secondary Outcome Measures

Name	Time	Method
Patient mean pain as measured on a 0-10 NRS[1, 2 and 4 weeks after screening positive for having clinically significant worst pain (2+ on 0-10 NRS)];Patient quality of life (QOL) as measured by the EORTC QLQ C15-PAL[1, 2 and 4 weeks after screening positive for having clinically significant worst pain];Carer experience, measured by the Carer Experience Scale (CES)[2 and 4 weeks after participating recipient of care screened positive for having moderate-severe worst pain];Patient empowerment, measured by the Health Education Impact Questionnaire (heiQ)[1, 2 and 4 weeks after screening positive for having clinically significant worst pain];Cost effectiveness, as measured by incremental cost per quality adjusted life year (QALY)[Period of 4 weeks since patient screened positive for clinically significant worst pain]