Administrative Procedures of the CanTalk Study
Summary
Researchers screen for eligible CanTalk Study patients at a number of sites; including oncology clinics at hospitals
such as UCLH and Kings, as well as the Marie Curie Hospice in Hampstead.
The Study is also open at sites outside of London, such as Coventry and South Tyneside.
Eligible patients are given information about the study, and if they agree to take part, the researchers obtain
consent.
Patients are entered onto the CanTalk database, where they are randomised into one of two arms; the
Treatment as Usual arm (where they are followed up every six weeks on four occasions by our researchers)
or
the Treatment as Usual PLUS Cognitive Behavioural Therapy (In addition to being followed up, patients will
receive up to twelve sessions of CBT with a local CanTalk-trained therapist)
These CBT sessions should run parallel with the follow ups.
CBT Referral Process
The CBT treatment phase starts from the date of randomisation.
This means that patients are referred for CBT as soon as they are randomised to the CBT treatment arm.
You – or your service administrator – will be contacted (usually by email) to confirm that the patient is indeed
eligible for your services.
The correspondence you will receive contains basic patient details, as well as an information sheet on how to
use the online Dropbox facility (included in this pack).
Please acknowledge receipt of this correspondence with the CanTalk Administrator.
You are required to contact the patient within two weeks of receiving their referral, to confirm an initial session
date, location and time.
Please inform the CanTalk Administrator when this has been done.
CBT Scheduling
Use the Patient CBT Appointment Schedule document (included in this pack) to note down all – including those
missed and/or rescheduled - session dates and times and give this to the patient.
Once all of the sessions have been completed, please return to the CanTalk Administrator.
This information is particularly important as we use it to see
whether attendance affects treatment outcomes.
Audio recording of CBT Sessions
We would like sessions to be recorded for quality assurance purposes.
Please ask the patient if they are happy for you to record and upload the sessions, and ensure that they sign and
date the Audio Consent Form (included in this pack).
Patients who refuse to consent to recordings being made of their sessions can still receive therapy, but please
inform the CanTalk Administrator should this occur.
CBT Documentation
After each session, the following should be completed:
1. CBT Components Checklist (included in this pack)
2. PHQ-9
3. Patient CBT Appointment Schedule (included in this pack)
4. Upload session audio via Dropbox (if the patient has consented to this)
Once the patient has completed all sessions of their therapy, please inform the CanTalk Administrator.
Adverse Events
Where participants show significant deterioration in mood, or suicidal intent, please follow the CanTalk Adverse
Events protocol (included in this pack).
Follow your IAPT Service procedures and inform the CanTalk Administrator straightaway.
Non attendance and Withdrawal
Normal procedures apply when dealing with non-attendance, but please take into account that CanTalk
participants may find attendance at their CBT sessions difficult due to physical limitations or urgent medical
care.
Taxis are provided when necessary, and are arranged by the CanTalk Administrator.
If for any reason, participants become uncontactable or inform you of their desire to withdraw from the study,
please let the CanTalk Administrator know.
Contacts
Below are contact details for the CanTalk Study Office:
CanTalk Study Office
CanTalk Administrator: Terrie Fiawoo
Email: dop.cantalkadministrator@ucl.ac.uk
Telephone: 0207 679 9741
CanTalk Trial Manager: Trefor Aspden
Email: t.aspden@ucl.ac.uk
Telephone: 0207 679 9209
Address: CanTalk Study, UCL Division of Psychiatry,
First Floor Charles Bell House, 67 -73 Riding House Street,
London, W1W 7EJ
Shared email address: cantalk@ucl.ac.uk
Twitter: @UCLcantalkstudy
Website: www.ucl.ac.uk/cantalk
Please contact Terrie for patient-specific queries, so the rest
of the CanTalk Study team remain blinded
For CBT-specific queries, please contact the lead specific to your area:
North and East London, Coventry and Warwickshire: Dr. Marc Serfaty
Email: m.serfaty@ucl.ac.uk
Telephone: 0207 679 9712
South London, Brighton: Dr. Stirling Moorey
Email: stirling.moorey@slam.nhs.uk
Telephone: 0203 228 2383
NE and NW England: Dr. Kath Mannix
Email: Kathryn.mannix@nuth.nhs.uk
Telephone: 0191 282 4019
Dropbox Instructions
Sending audio recordings via online Drop Box
 Go online to the CanTalk website at www.ucl.ac.uk/cantalk
 Click on the “Drop your file(s)” link on the left hand side.
 You will be directed to UCL secure drop box website
(www.ucl.ac.uk/dropbox/)
 Select the “drop off” button
 Enter your details and the details of our CanTalk Administrator

(Name: Terrie Fiawoo; Email:
dop.cantalkadministrator@ucl.ac.uk)
 Upload each of the audio recordings by clicking on “Choose File”
 Please save your file as Patient ID – Session Number- Date of Session

Example 005009-S07-120713
 You will receive a confirmation email once your files have been sent.
Patient CBT Appointment Schedule
CBT Therapist name: ___________________________ Participant ID: ________________
Contact Number:
___________________________
Location:
____________________________
____________________________
_____________________________
Please contact your CBT Therapist on the number above if you are unable to make your appointment
Appointment type
Initial/Session 1
Appointment date
Appointment time
Session 2
Session 3
Session 4
Session 5
Session 6
Session 7
Session 8
Session 9
Session 10
Session 11
Session 12
Return this sheet to your therapist once all of your sessions have been completed – thank you
Therapist – please return this sheet to the CanTalk Administrator once completed.
CanTalk - Serious Adverse Events Protocol
Serious Adverse Event (SAE):
A Serious Adverse Event (SAE) is an untoward occurrence experienced by a participant which:





results in death;
is life-threatening;
requires hospitalisation or prolongation of existing hospitalisation;
results in persistent or significant disability or incapacity;
is otherwise considered medically significant by the investigator.
Serious Adverse Events
Suicide intent, self-harm and overdose are highly unlikely, but are associated with major depression
and therefore would be an expected SAE. We do not expect treatment to cause the above events.
Therefore if any of the following SAEs are reported or observed then the SAE procedure should be
implemented as soon as participant safety has been assured.
1. Suicide ideation or intention
Suicide Ideation is characterised by thoughts of suicide without clear intention or plan to attempt
suicide. Suicide intention is characterised by intentions or plans to attempt suicide. If participant
reports possible suicide ideation or intention they will be assessed for suicide risk using the MINI
Section C: Suicidality at screening or the BDI-II during follow ups.
a) Low to Moderate risk:
i. At home: They will be encouraged to contact the GP if mood continues to deteriorate.
They will be asked for consent to call GP on their behalf and a family member. If they
refuse contact with GP or family, but are still at high risk to themselves or others, proceed
to call GP
ii. At Healthcare setting: Ask the patient to speak with their GP/Oncologist, or see the
psychological support services available.
b) High risk: (i.e. the participant reports immediate suicide intent):
i. At Home: They will be asked to contact their GP immediately – either themselves or on
their behalf. Check if a relative can be contacted. Remain with them until a family member
or the GP arrives. Follow up with the research site to inform them of event. Where the
participant refuses help and risk is deemed immediately life threatening then the police
should be notified.
ii. At Healthcare setting: They will be encouraged to contact their GP immediately. Remain
with them until a family member or the GP arrives. If in the patient’s home, inform research
site of event. Where the participant refuses help and risk is deemed immediately life
threatening then the police may also be notified.
2. Self-harm
a) If participants exhibit any signs of self-harm they will be encouraged to contact their GP that
day. In the event that they refuse to seek help and their safety is a concern, their GP will be
notified.
b) Where the participant refuses help and risk is deemed immediately life threatening then the
police should also be notified.
3. Overdose
a) If the participant reports or exhibits signs of excessive drug consumption/ intention to overdose
they will be encouraged to contact their GP that day.
b) In the event that they refuse to seek help and their safety is a concern, their GP will be notified.
Reporting Serious Adverse Events (SAEs)
In accordance with the National Patient Safety Agency’s requirements for reporting SAEs, any SAE
deemed to be related or unexpected will initially be reported to the CI, and then David Wilson
(sponsor) within 24 hours. After consultation with the CI, a report will be made to the Research Ethics
Committee and the study Data Monitoring and Ethics committee within 15 days.
Life threatening or hospitalising medical diagnoses/assessments related to cancer or other physical comorbidities are considered expected and unrelated SAEs and do not need reporting within 24 hours.
CanTalk - Reporting serious adverse events (SAEs) Flow Chart
Notification of adverse event received
Is the incident assessed as serious?
In the CanTalk study a Serious Adverse Event (SAE) is an untoward
occurrence, experienced by the participant, which:





Resulted in death;
Was life-threatening;
Required hospitalisation or prolongation of existing
hospitalisation;
Resulted in persistent or significant disability or incapacity;
Is otherwise considered medically significant by the principal
investigator.
1.
A Researcher or Principal Investigator (PI) should complete
Section A of the CanTalk Serious Adverse Event (SAE) Form
electronically. If completed by a Researcher, the SAE Form
should then be forwarded to their local PI.
2.
The PI should complete Section B of the SAE Form
electronically, as far as possible.
3.
4.
The PI should send the SAE Form electronically to:
m.serfaty@ucl.ac.uk and t.aspden@ucl.ac.uk
5.
The PI should print 2 copies and sign and date both forms.
One should be retained in the Investigator’s Site File and the
other should be sent to:
Mr. Trefor Aspden
CanTalk Trial Manager
UCL Division of Psychiatry
1st Floor Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
6.
At UCL, the Chief Investigator should complete Section C of
the SAE Form.
7.
Where the SAE is deemed to be related to the CanTalk trial,
the CI will notify (within 15 days) the following:
i. Main REC;
ii. Trial DMEC.
8. The SAE Form should be filed in the Trial Master File (TMF).
No further
action
required.
Within 24 Hours
Yes
No
CanTalk
SERIOUS ADVERSE EVENT (SAE) REPORTING FORM
01
02
Date of Birth.
04
05
Responsible Clinician.
Patient’s Initials.
Hospital Name.
03
Participant’s Trial No.
SECTION A:
06
07
Please indicate below the category which best describes the SAE.
Date of SAE:
1 = Death
2 = Life-threatening (including attempted suicide, overdose, self-harm)
3 = Requires hospitalisation or prolongation of existing hospitalisation
4 = Results in persistent or significant disabaility or incapacity
5 = Other (considered medically relevant), specify
………………………………………………….
08
Where did the SAE happen
09
How did the centre become aware of the incident?
10
Descibe serious adverse event :
SECTION B: To be completed by the Principal Investigator
11
Did this SAE arise as a result of the participant’s involvement in the CanTalk trial?
Yes
□ No □
12
Any other comments
13
Name of PI (print)
14
Signature of PI
15
Date
Please print two copies. Please send by post to the address below and retain a copy for the Site File.
Mr. Trefor Aspden
CanTalk Trial Manager
UCL Division of Psychiatry
1st Floor Charles Bell House
67-73 Riding House Street
London, W1W 7EJ
SECTION C: To be completed by Chief Investigator
16
Action Taken
……………………………………………………………………………………………………………………
17
Name of CI (print) ……………………………………………………………………………..
18
Signature of CI …………………………………………………………………
19
Date _ _ / _ _ / _ _