Phase II of a novel telehealth-mediated nurse-led intervention to increase oral cancer therapy adherence amongst people with Chronic Myeloid Leukaemia (CML)(REMIND study)

Phase 2

Completed

• Conditions: chronic myeloid leukaemia (CML); Cancer - Leukaemia - Chronic leukaemia

• Registration Number: ACTRN12612000635864
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.a confirmed diagnosis of CML in the chronic phase with no signs and symptoms of progression to the accelerated or blastic phases as per investigator’s opinion
2.no evidence of Imatinib resistance (as determined by the site investigator)
3.Currently taking or about to commence treatment with Imatinib
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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the clinical feasibility and acceptability of the intervention with 40 patients with CML by interviewing stakeholders involved e.g clinician, patient[end of trial];To evaluate a nurse-led, telehealth-mediated intervention employing web and mobile based reminder systems (Remind) to help people with CML improve adherence to their oral medication and effectively manage medication side-effects better. Management of side effects will be evaluated through patient reproted outcomes on the The Memorial Symptom Assessment Scale Short Form. Adherence will be measured through pill counts.[end of trial]

Secondary Outcome Measures

Name	Time	Method
Determine the suitability of a specially designed pill monitoring device, supplied by Novartis, for future trials. This will be informally evaluated through discussion with select patients and clinicians.[end of trial];Determine the suitability of patient reported outcome measures and acceptability of new NIH-Funded Patient Reported Outcomes Measurement Interactive System28 (PROMIS) online data collection system for future trials. This will be informally evaluated through discussion with select patients and clinicians.[end of trial];Establish recruitment rates and research procedures to inform final design and methods of a future phase III trial[end of trial];Estimate the potential effect size and coefficient of variation on which to base power calculations for an adequately powered phase III trial[end of trial]