eSMART Trial to Evaluate ASyMS

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT02356081
• Date of registration: 26/01/2015
• Prospective Registration: Yes
• Primary sponsor: Louise McKean
• Public title: eSMART Trial to Evaluate ASyMS
• Scientific title: eSMART: Randomised Controlled Trial to Evaluate Electronic Symptom Management Using the Advanced Symptom Management System (ASyMS) Remote Technology for Patients With Cancers
• Date of first enrolment: February 2015
• Target sample size: 829
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02356081
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Greece, Ireland, Norway, United Kingdom

Contacts

• Name: Roma Maguire
• Affiliation: University of Strathclyde

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with breast cancer, colorectal cancer, or haematological malignancies (i.e.
HD or NHL).

- Scheduled to receive first-line cytotoxic chemotherapy.

- Scheduled to receive 2-, 3- or 4-weekly chemotherapy protocols (i.e. chemotherapy
administered at repeated cycles of 14, 21 or 28 days, respectively).

- Planned to receive a minimum of 3 chemotherapy cycles.

- Deemed physically/psychologically fit to participate in the study by a member of the
multidisciplinary team.

- Able to understand and communicate in the respective language.

Exclusion Criteria:

- Patients with breast cancer or colorectal cancer with a distant metastasis, i.e. stage
IV disease as defined by the TNM/UICC, (at the start of their chemotherapy treatment).

- Patients with a haematological malignancy (HD or NHL), who have B symptoms, (at the
start of their chemotherapy treatment).

- Scheduled to receive concurrent radiotherapy during chemotherapy treatment.

- Scheduled to receive weekly chemotherapy protocols. Also, patients who shift from a
2-, 3- or 4-weekly protocol to a weekly protocol during chemotherapy will be excluded
from further participation in the study.

- Diagnosed with the same type of cancer (i.e. where relapse has occurred) AND/OR
another type of cancer (the only exception non-melanoma skin cancer) within the 5
years prior to recruitment to the study.

- Received chemotherapy treatment for any medical reason within the last 5 years, unless
this is chemoradiation for colorectal cancer.

- Unable to provide written informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Other: ASyMS intervention Group

Primary Outcome(s)

Memorial Symptom Assessment Scale (MSAS) [Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy.]

Secondary Outcome(s)

Communication and Attitudinal Self-Efficacy scale for cancer [Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy.]

Memorial Symptom Assessment Scale (MSAS) [Time Frame: At the halfway point during each cycle of chemotherapy (each cycle can be wither 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy.]

State-Trait Anxiety Inventory-Revised [Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy.]

Supportive Care Needs Survey Short Form [Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy.]

Functional Assessment of Cancer Therapy General (FACT-G) [Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy.]

Work Limitations Questionnaire [Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy.]

Secondary ID(s)

CRC331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Docobo Ltd.

King's College London

University of Athens

Medical University of Vienna

Sykehuset Innlandet HF

University of California, San Francisco

European Cancer Patient Coalition (ECPC)

University College Dublin

University of Dundee

University of Surrey