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Trial registered on ANZCTR


Registration number
ACTRN12609000384257
Ethics application status
Approved
Date submitted
15/01/2009
Date registered
29/05/2009
Date last updated
29/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Heads Up: A Phase II trial of a radiotherapy-based intervention for depression and malnutrition in Head and Neck cancer patients.
Scientific title
Heads Up: A Phase II trial of a radiotherapy-based intervention for depression and malnutrition in Head and Neck cancer patients.
Universal Trial Number (UTN)
Trial acronym
Heads Up
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition and depression in Head and Neck Cancer during radiotherapy 4202 0
Condition category
Condition code
Cancer 4412 4412 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is provided to participants while undergoing radiotherapy, which can vary between 20 and >40 treatments. It is provided by a psychologist in 10minute sessions twice weekly, following radiotherapy for the duration of treatment. At each session, participants receive Psycho-Education for depression, Cognitive Behaviour Therapy for depression, Motivational Interviewing for nutritional compliance. These are psychological therapies and involve short discussions with a psychologist.
Intervention code [1] 3917 0
Behaviour
Comparator / control treatment
The control group was a sample of Head and Neck Cancer patients recruited in 2007-2008 as part of an earlier observational study using identical inclusion criteria. The control group did not receive any Psychological intervention and received radiotherapy treatment as usual. In the context of a psychological intervention within an oncology population, the historical control group was considered to have been the "no treatment" arm of the study.
Control group
Historical

Outcomes
Primary outcome [1] 5297 0
Malnutrition: >9 on the Patient Generated Subjective Global Assessment (PG-SGA) nutritional assessment tool
Timepoint [1] 5297 0
First week of treatment, Last week of treatment and four weeks post treatment
Primary outcome [2] 5298 0
Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9)
Timepoint [2] 5298 0
First week of treatment, Last week of treatment and four weeks post treatment
Secondary outcome [1] 8920 0
European Cooperative Oncology Group Performance Status (ECOG)
Timepoint [1] 8920 0
First week of treatment, Last week of treatment and four weeks post treatment

Eligibility
Key inclusion criteria
Head and Neck Cancer, >20 fractions of radiotherapy (non-palliative).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to read and/or write in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4386 0
Government body
Name [1] 4386 0
Cancer Institute NSW
Country [1] 4386 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Locked Bag 7
Hunter Region Mail Centre
NSW, 2310
Country
Australia
Secondary sponsor category [1] 3945 0
Individual
Name [1] 3945 0
A/Prof Gregory Carter
Address [1] 3945 0
Locked Bag 7
Hunter Region Mail Centre
NSW, 2310
Country [1] 3945 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6434 0
Hunter New England Human Researcf Ethics Committee
Ethics committee address [1] 6434 0
Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 6434 0
Australia
Date submitted for ethics approval [1] 6434 0
Approval date [1] 6434 0
Ethics approval number [1] 6434 0

Summary
Brief summary
This study looks at the effectiveness of additional psychological support for people receiving radiotherapy for head and neck cancer in helping with depression and malnutrition.

Participants will receive: - psycho-education for depression - cognitive behaviour therapy for depression - motivational interviewing for improving nutrition. These are 10 minute sessions, twice weekly, following radiotherapy treatments.

Participants are assessed for depression and malnutrition during the first week of treatment, last week of treatment and four weeks after treatment. Depression and malnutrition are both measured using validated assessment tools.

The study aims to see whether depression and malnutrition can be effectively addressed by providing additional psychological support.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35094 0
Address 35094 0
Country 35094 0
Phone 35094 0
Fax 35094 0
Email 35094 0
Contact person for public queries
Name 12441 0
Dr Ben Britton
Address 12441 0
Locked Bag 7
Hunter Region Mail Centre
NSW, 2310
Country 12441 0
Australia
Phone 12441 0
+61 2 4921 1254
Fax 12441 0
Email 12441 0
[email protected]
Contact person for scientific queries
Name 3369 0
Dr Ben Britton
Address 3369 0
Locked Bag 7
Hunter Region Mail Centre
NSW, 2310
Country 3369 0
Australia
Phone 3369 0
+61 2 4921 1254
Fax 3369 0
Email 3369 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.