Conference Proceedings - School of Nursing & Midwifery - Trinity ...

School of Nursing & Midwifery, Trinity College Dublin: 8 th Annual Interdisciplinary Research Conference
Transforming Healthcare Through Research, Education & Technology: 7 th – 9 th November 2007
Conference Proceedings
from the Rotterdam Symptom Checklist (RSCL) and the possible
psychological effects that completing DDCs had on patients. This
was complemented by semi-structured interviews to explore the
patients’ experience of completing the DDCs.
By adopting a complementary design approach, it was possible to
delineate the data each method generated and analyse it
separately.
Design
This study is a randomised controlled trial, comprising two groups:
an intervention group and a control group.
Patients with breast or colorectal cancer receiving adjuvant
chemotherapy (that is chemotherapy treatment after potentially
curative surgery) were therefore randomly assigned to the
treatment or control group. Randomisation was achieved as follows:
the data manager within the cancer unit randomly allocated a
patient number to either the intervention or the control group.
Patient allocation was only revealed to the researcher after the
patient had been given a study number. Through such
randomisation, every participant had an equal chance of being
included in the treatment or control group.
Study setting, sample and selection
All the patients recruited to this study were from a population of
patients attending a cancer unit pre-assessment chemotherapy
clinic at a large District Hospital. They had been diagnosed with
pathologically confirmed breast or colorectal cancer needing
adjuvant chemotherapy. Patients with a colorectal diagnosis
received 5-fluorouracil (5FU) chemotherapy via a continuous
infusion over twenty four weeks changed weekly or as a weekly
injection of 5FU over twenty four weeks. Patients with a breast
cancer diagnosis received either epirubicin at three weekly intervals
for four cycles (Epi) followed by cyclophosphamide, methotrexate
and 5FU (CMF) at three weekly intervals for four cycles, or 5FU,
epirubicin and cyclophosphamide (FEC) given at three weekly
intervals over six cycles.
All new patients who fulfilled the entry criteria were approached by
the researcher or a research nurse and asked to participate in this
study prior to the commencement of their first chemotherapy
treatment.
All participants were given a description of this study including a
written information sheet at their pre-assessment chemotherapy
visit. A week later, and prior to commencing their chemotherapy,
patients who had agreed to participate in the study were asked to
sign a consent form. They were then randomised to either the
intervention or control group by the data manager. Although
patients were receiving chemotherapy for six cycles or twenty-four
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