Cancer Clinical Trial
Official title:
An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
The aim of the project is to investigate opioid-induced constipation (OIC) in a real world /
diverse group of patients with cancer.
The objectives of the project are to determine: a) prevalence of OIC; b) clinical features /
impact of OIC; c) management of OIC.
StOIC-1 is an observational study, and will involve a single visit (see below for schedule).
The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer
diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug,
formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance
status
The participants will be asked the following questions:
1. Simple question - "Are you constipated?" [Options - yes / no / unsure]
2. European Association for Palliative Care definition question - "Does the following
question describe your bowel function: 'the passage of small, hard faeces infrequently
and with difficulty?' [Options - yes / no / unsure]
3. Camilleri definition question - "Does the following statement describe your bowel
function: 'a change since initiating opioid therapy from baseline bowel habits that is
characterised by any of the following: reduced bowel movement frequency, development or
worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation,
harder stool consistency?' [Options - yes / no / unsure
4. Rome IV diagnostic criteria for OIC
The participants will also be asked to complete:
1. Bowel function index (BFI). The BFI is a validated, 3 item, patient-reported tool for
assessing the treatment of OIC. A BFI score of ≥30 indicates suboptimally treated OIC.
2. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL). The
PAC-QOL is a validated, 28-item, patient-reported tool for assessing the impact of
constipation over time.
3. Memorial Symptom Assessment Scale - Short Form (MSAS-SF). The MSAS-SF is a validated, 32
item, patient-reported tool for assessing physical and psychological symptoms in cancer
patients.
The participant will also undergo a palliative care specialist assessment for constipation /
OIC. The palliative care specialist will be asked to review the patient with regard to their
bowel function, and then asked the following questions: a) does the patient have
constipation? [Options - yes / no / unsure]; b) (if appropriate) does the patient have
opioid-induced constipation? [Options - yes / no / unsure]; c) (if appropriate) does the
patient have additional causes of constipation? [Options - yes / no / unsure]; d) (if
appropriate) what additional causes of constipation?I
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