Contact information
Type
Scientific
Primary contact
Prof Vivien Coates
ORCID ID
Contact details
Altnagelvin Hospital
Glenshane Road
Londonderry
BT47 6SB
United Kingdom
+44 (0)28 71345171 x 3037
Viv.Coates@westerntrust.hscni.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The development and evaluation of an individualised information package for patients with rectal cancer: a randomised controlled trial
Acronym
Study hypothesis
Does a tailored information package for people with rectal cancer affect anxiety, length of consultation and number of follow-up consultations with the Stoma Care Nurse Specialist (SCNS)? Does a tailored information package help to prepare patients for survivorship following a diagnosis of rectal cancer?
Ethics approval
Office for Research Ethics Committees in Northern Ireland (ORECNI), approved on 09/07/2008 (ref: 08/NIR01/36)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer of the rectum
Intervention
The intervention group will receive a series of leaflets from the newly designed information pack depending on their condition, treatment plan and choice of information. To assist people with literacy difficulties and to ensure that the leaflets' content is understood the SCNS will go through a "guided tour" of the information leaflets with each patient in the intervention group.
The intervention group will also receive the usual care that they would receive at any appointment with the Nurse Specialist. The nurse will discuss their condition, treatment options and concerns. The patients will also have an opportunity to ask questions. The control group will receive usual care and will receive the generic colorectal cancer leaflets currently used in usual care. The length of the consultations for both the intervention and control groups will be recorded.
The total duration of the study and follow-up is approximately seven months with data collection at time 1 (at diagnosis) time 2 (just before discharge from hospital after surgery) and time 3 (six months after time 2).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Satisfaction with information, assessed using Patient Satisfaction with Cancer Treatment Education (PS-Ca-TE) at T1, T2 and T3
2. Anxiety will be measured using the Hospital Anxiety and Depression Scale at T1, T2 and T3
3. Health behavioural style, assessed by the Monitor-Blunter style scale at T1 only
4. Preparation for Survivorship will be measured using Reintegration to Normal Living Index at T1, T2 and T3
Length of consultation with the Stoma Care Nurse Specialist and number of follow-up appointments with the Stoma Care Nurse Specialist will be recorded by the Stoma Care Nurse Specialist for the duration of the study for each participant.
Timepoints for data collection:
T1: At diagnosis
T2: Just before discharge from hospital after surgery
T3: Six months after T2
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/12/2008
Overall trial end date
31/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, no age limits
2. Patients with a new diagnosis of rectal cancer
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
94
Participant exclusion criteria
Patients at an advanced stage of illness who are under the care of the palliative care team or who are considered to have a prognosis of less than six months.
Recruitment start date
01/12/2008
Recruitment end date
31/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Altnagelvin Hospital
Londonderry
BT47 6SB
United Kingdom
Sponsor information
Organisation
Western Health and Social Care Trust (UK)
Sponsor details
Altnagelvin Hospital
Glenshane Road
Londonderry
BT48 8RR
United Kingdom
+44 (0)28 71345171
Gloria.OConnor@westerntrust.hscni.net
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Ireland Health and Social Services Central Services Agency, R&D Office (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24275208