Assessment of the ‘Managing Advanced Cancer Pain Together’ (MACPT) tool to facilitate communication on total cancer pain between advanced cancer patients and their healthcare professionals (20160376)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Patient survey
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Short-term pre-post study design

Study drug and medical condition

• Medical condition to be studied:
  Cancer pain

Population studied

• Short description of the study population:
  Advanced cancer patients.; - Age 18 years or older; - A diagnosis with one of the following primary cancer type: breast cancer, prostate cancer, lung cancer or multiple myeloma; - A record of stage IV, metastatic status, distant spread, or bone pain due to cancer metastases/bone lesion(s), specifically:; o Patients with breast cancer must be diagnosed with advanced or metastatic disease.; o Patients with prostate cancer must have a nodal or metastatic condition.; o Patients with lung cancer must have stage IIIB or stage IV non-small cell lung cancer or advanced small cell lung cancer.; o Patients with multiple myeloma; - Ability to read, write and understand English, French or German (in accordance with the site he/she has been recruited from); - Sufficient capabilities to participate in the study (as assessed by the HCP); - No significant difficulty with hearing, reading or speaking; - No diagnosed memory impairment
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Cancer patients
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The overall objective of this study is to assess the MACPT conversation tool, developed to support a comprehensive pain dialogue between advanced cancer patients and their HCPs during their routine face-to-face consultation.
• Outcomes:
  To assess the impact of the MACPT tool on patient- and HCP- reported overall satisfaction score (as measured using the patient- and HCP versions of the satisfaction questionnaire) of their conversation during face-to-face routine standard-of-care (SoC) consultations. To assess the impact of the MACPT tool on patient and HCP reported satisfaction score. To describe the frequency of the tool words selected by the patients as a proxy for elucidating the themes or components of total cancer pain. To assess the usefulness of the MACPT conversation tool in helping HCPs identify key aspects of the patient’s total pain experience.
• Data analysis plan:
  The analytic focus will be on pre- and post- MACPT tool exposure.The primary analysis will entail comparing the mean change in patient reported overall satisfaction scores of their conversation during face-to-face routine standard-of-care consultations before and after use of the MACPT tool, a paired t-test will assess if the mean change differs from zero. The mean change in HCP-reported overall satisfaction score before and after use of the MACPT tool will also be compared in the same manner, and treated as a co-primary endpoint.The secondary analyses include comparing the mean change in patient- and HCP- reported satisfaction score on specific aspects of their conversation during face-to-face routine standard-of-care (SoC) consultations, calculating the frequency and percentage of patients selecting each pain descriptor of the MACPT tool. Both patient and HCP’s responses to the brief questionnaire on the MACPT tool’s usefulness will also be descriptively summarized.