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. 2020 Jun 2;2020(6):CD007568. doi: 10.1002/14651858.CD007568.pub2

Thomas 2012.

Study characteristics
Methods Setting: California and New Jersey, USA
Recruitment: eligible participants were 18 years of age or older, were able to read and understand English, had access to a telephone, had a life expectancy longer than 6 months, had cancer‐related pain with an average pain intensity score of 2 or higher (on a 0 to 10 scale), had no cognitive or psychiatric condition, had no substance abuse problem, had no severe pain unrelated to their cancer, or resided in a setting where they could not self‐administer pain medication (e.g. nursing home). Potential participants were identified by clinical staff and were recruited from 6 outpatient oncology clinics (4 Veterans Affairs facilities, 1 county hospital, and 1 community‐based practice) by a member of the research team
Randomisation: RCT; participants were stratified by pain intensity and treatment via permuted blocks with variable sizes
Participants 318 men and women aged 18 years or older with various types of cancer‐related pain
Interventions Intervention: based on change theory, specifically the Transtheoretical Model, in which behavioural change is a function of a person's state of readiness or motivation to modify a particular behaviour. Uses principles of coaching and motivational interviewing to modify participants' attitudes towards pain management. Participants received either (1) an educational intervention or (2) a coaching intervention. Both groups viewed a video on overcoming attitudinal barriers and received a pamphlet on managing cancer pain. In addition, all participants received 4 × 30 minute biweekly telephone calls conducted over 6 weeks. In the coaching group, the calls explored participants' beliefs about pain, use of pain medication, non‐pharmacological pain management strategies, and communication about pain management. In the educational and usual care groups, the calls were for attention control (content not described)
Control group: usual care. Participants viewed a video on cancer produced by the American Cancer Society
Interventionist: advanced practice oncology nurse with expertise in cancer pain management trained in the Transtheoretical Model and in motivational interviewing by a cognitive‐behavioural psychologist, and in the specific coaching protocol used in the study. Research associates were trained in providing attention control telephone calls for the control group
Outcomes
  • Psychological symptoms ‐ attitudinal barriers to pain management

  • Physical symptoms ‐ pain

  • Impact on quality of life/functioning ‐ functional status, quality of life


Methods for assessing outcomes:
  • Barrier Questionnaire (BQ)

  • Brief Pain Inventory (BPI)

  • MOS 36‐item Short Form Health Survey (SF‐36)

  • Functional Assessment of Cancer Therapy Scale (FACT‐G)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised via permuted blocks with variable sizes
Allocation concealment (selection bias) Low risk Participants and clinicians were blinded to participants' group assignments
Blinding (performance bias and detection bias)
All outcomes High risk Owing to the nature of the intervention, participants and personnel were not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk Loss to follow‐up over 20%; no detail provided on reasons for loss to follow‐up between study groups
Selective reporting (reporting bias) Low risk There appears to be no selective reporting
Other bias Low risk The trial appears to be free of other problems that could put it at high risk of bias