Condition category
Cancer
Date applied
22/11/2008
Date assigned
30/01/2009
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.westerntrust.hscni.net/

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

Results - basic reporting

Publication summary

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24275208

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.