SAMSON: Trial of a nurse and pharmacist-led mobile health management system.

Not Applicable

Withdrawn

• Conditions: Public Health - Health service research; small lymphocytic lymphoma; chronic lymphocytic leukaemia; waldenstrom's macroglobulinaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Other cancer types; mantle cell lymphoma

• Registration Number: ACTRN12618001798257
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-05
• Last Update Posted: 28 October 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) A confirmed diagnosis of CLL/SLL/MCL/WM and scheduled to commence ibrutinib by treating haematologist/oncologist as part of routine care.
2) No evidence of ibrutinib resistance (as determined by the site investigator).
3) Commencing treatment or currently treated with ibrutinib or treated for <2 months.
4) Over 18 years.
5) Proficient in English.
6) Able to give informed consent.
7) An ECOG performance status score of 2 or less at Screening
8) Accessibility to the internet and a smart phone

Exclusion Criteria

1) Demonstrated cognitive or psychological difficulties that would preclude study participation as defined by the treatment team’s cognitive and / or psychiatric assessment or patient’s disclosed medical history
2) Too unwell to participate in the study as determined by the patient’s treatment team.
3) Adjunct pharmacological treatment for CLL/SLL/MCL/WM (disease specific, not symptom specific)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability of the program (smartphone application and nurse/pharmacists teleconsultations) by patients and healthcare professionals.<br>This will be done via patient and healthcare professional exit interviews. Patient exit interviews will be conducted once their enrolment in the study has concluded (after 6 months). Healthcare professional (nurse and pharmacist) exit interviews will be conducted once the study has concluded (after 2 years).[Patient - 6 months post initial session.<br>Healthcare professional - 2 years post study commencement.];Feasibility of the program to be conducted across different healthcare settings.<br>This will be done via a cost analysis of data acquired through Medicare and Pharmaceutical Benefits Scheme, and the Australian Refined Diagnosis Related Group data.[2 years post study commencement.]