The development and evaluation of an individualised information package for patients with rectal cancer

ISRCTN	ISRCTN42959693
DOI	https://doi.org/10.1186/ISRCTN42959693
Secondary identifying numbers	N/A

Submission date: 22/11/2008
Registration date: 30/01/2009
Last edited: 27/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Vivien Coates
Scientific

Altnagelvin Hospital
Glenshane Road
Londonderry
BT47 6SB
United Kingdom

Phone	+44 (0)28 71345171 x 3037
Email	Viv.Coates@westerntrust.hscni.net

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The development and evaluation of an individualised information package for patients with rectal cancer: a randomised controlled trial
Study objectives	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(s)	Office for Research Ethics Committees in Northern Ireland (ORECNI), approved on 09/07/2008 (ref: 08/NIR01/36)
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2008
Completion date	31/08/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	94
Key inclusion criteria	1. Both males and females, no age limits 2. Patients with a new diagnosis of rectal cancer
Key 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.
Date of first enrolment	01/12/2008
Date of final enrolment	31/08/2010

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Altnagelvin Hospital

Londonderry
BT47 6SB
United Kingdom

Sponsor information

Western Health and Social Care Trust (UK)
Hospital/treatment centre

Altnagelvin Hospital
Glenshane Road
Londonderry
BT48 8RR
Northern Ireland
United Kingdom

Phone	+44 (0)28 71345171
Email	Gloria.OConnor@westerntrust.hscni.net
Website	http://www.westerntrust.hscni.net/
"ROR"	https://ror.org/00sb42p15

Funders

Funder type

Government

Northern Ireland Health and Social Services Central Services Agency, R&D Office (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014		Yes	No

Editorial Notes

27/11/2015: Publication reference added.