Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000493347
Ethics application status
Approved
Date submitted
6/08/2008
Date registered
30/09/2008
Date last updated
30/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychological Intervention to reduce depression and anxiety in cancer patients undergoing chemotherapy
Scientific title
Psychological Intervention to reduce depression and anxiety in cancer patients undergoing chemotherapy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 3492 0
nausea in cancer patients 3493 0
Condition category
Condition code
Mental Health 3647 3647 0 0
Anxiety
Cancer 3648 3648 0 0
Other cancer types
Mental Health 3832 3832 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group 1: Cognitive behavioural (CB) coping with behavioural relaxation (BR): (Requires
delivery by specialist Psychology staff)

Patients in the CB coping with BR condition will individually attend the clinic approximately 3-5 days prior to their first scheduled chemotherapy session, for a 90-minute CB coping session. The session will incorporate a tour of the clinic and information on the sequence of events that will transpire when the patient comes in for their first chemotherapy session, including the relaxation protocol. The patient and their family will be shown a short video of a “coping model” undergoing chemotherapy. The Psychologist will be involved in assisting the patient to implement the strategies outlined in the video within the context of a CB coping framework. They will be encouraged to ask questions, liaise with their GP for support and will be given information on how to cope with specific side-effects. At each of the 5 chemotherapy sessions, up to 30 minutes will be spent review reviewing the CB coping session will be discussed and any questions or issues will be discussed within a CB model. In addition, at the patient’s first chemotherapy session, the BR protocol (a relaxation session of up to 30 minutes) will also be implemented as described below.


Intervention Group 2: Behavioural relaxation (BR) only: (Can be delivered by nursing and allied health
staff)

Participants in the BR only condition will individually attend the clinic approximately 3-5 days prior to their first scheduled chemotherapy session, for a 30-minute teaching session on progressive relaxation and a tour of the clinic. During the first chemotherapy session, the patient will be guided through the progressive relaxation, followed by a guided imagery exercise to encourage a deeper state of relaxation. This process will take approximately 30 minutes. During the guided imagery phase a nurse will begin the drug infusion. After chemotherapy, the relaxation session will be brought to a close and the postchemotherapy dependent measures will be administered. The patient will be asked to practice the relaxation session at home. The second and third chemotherapy sessions will be identical to the first. During the fourth and fifth sessions, the patient will be instructed to self-administer the relaxation and guided imagery procedures. Patient’s performance in this condition is of interest due to its greater applicability and ease of implementation by staff (e.g., nurses).
Chemotherapy occurs in "cycles" and varies somewhat between patients. Cycles generally include at least six separate attendances ("sessions") that may take between six and eighteen weeks to complete, depending on the individual's chemotherapy regime. i.e. some subjects will be attending chemotherapy weekly, whilst others may attend fortnightly or three-weekly. Thus the duration of the overall intervention will be between six and eighteen weeks.
Finally it is important to note that the chemotherapy component of each session (attendance) can take between 30 minutes and five hours, depending on their regime. The CB and/or BR components each occupy 30 minutes during the early part of he chemotherapy session. When the BR or combined CB/BR intervention has concluded, subjects will be invited to continue to apply the coping techniques as and when required during any remaining time of their chemotherapy session.
Intervention code [1] 3215 0
Other interventions
Comparator / control treatment
Control condition:

Participants in this condition receive an individual standard prechemotherapy orientation only on the day of their first chemotherapy session. At Austin Health orientation typically involves an explanation of the day oncology procedure, discussion of side effects, dissemination of an information folder and instructions on how to contact Oncology staff for additional support, information or urgent medical attention. The general orientation process usually takes approximately 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 4547 0
Improved coping: Measures: Derogatis Affect Balance Scale (DABS), Comprehensive Quality of Life Scale (ComQOL -4)
Timepoint [1] 4547 0
pre/post study (post study = administered immediately after patients' 5th chemotherapy session).
Primary outcome [2] 4548 0
reduced anxiety: measures Hospital Anxiety and Depression Scale (HADS), Self-rated anxiety on 7-point Likert scale
Timepoint [2] 4548 0
pre/post study; HADS will be administered before session 1 of chemotherapy and after session 5 of chemotherapy. Likert scale will be completed pre and post each of sessions 1 to 5 and for three days following the completion of chemotherapy treatment
Primary outcome [3] 4549 0
reduced depression: measures: HADS, DABS
Timepoint [3] 4549 0
pre/post study: pre is immediatelt before first chemotherapy session, post is administered immediately after patients' 5th chemotherapy session.
Secondary outcome [1] 7700 0
reduced nausea: measure self-rated nausea as rated on 7 point Likert scale
Timepoint [1] 7700 0
during each of 5 sessions of chemotherapy treatment. Overall time will vary depending on the frequency with which subjects have their chemotherapy treatment.

Eligibility
Key inclusion criteria
Individuals undergoing outpatient chemotherapy for cancer for first time. Austin Health patients only.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
acutely unwell, inability to participate in treatment, inability to complete measures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be referred to investigators by their Oncologist, who will be unaware as to which condition each individial will be allocated. Allocation concealment will be achieved by means of a coded, double-blinded, variable length permuted blocks randomized treatment allocation schedule will be produced by computer algorithm. The schedule will be retained in a secure place by an independent person blind to the meaning of the coding. As new participants join the study they will be allocated the next coded position.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coded, double-blinded, variable length permuted blocks randomized treatment allocation schedule will be produced by computer algorithm
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
mental health measures are following first and last chemotherapy sessions. Nausea/emesis measures are weekly.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3692 0
Government body
Name [1] 3692 0
Victorian Cancer Agency (Supportive Care infrastructure grant)
Country [1] 3692 0
Australia
Primary sponsor type
Government body
Name
Victorian Cancer Agency
Address
12 Victoria Street
Carlton
Melbourne
Victoria 3053
Country
Australia
Secondary sponsor category [1] 3309 0
Hospital
Name [1] 3309 0
Austin Health
Address [1] 3309 0
Austin Hospital 145 Studley Road Heidelberg Victoria VIC 3084
Country [1] 3309 0
Australia
Other collaborator category [1] 357 0
Hospital
Name [1] 357 0
Austin Health Cancer Services
Address [1] 357 0
Austin Hospital 145 Studley Road Heidelberg Victoria VIC 3084
Country [1] 357 0
Australia
Other collaborator category [2] 358 0
Hospital
Name [2] 358 0
Austin Health Department of Clinical and Health Psychology
Address [2] 358 0
300 Waterdale Road, Heidelberg West, Victoria, 3081
Country [2] 358 0
Australia
Other collaborator category [3] 359 0
Other Collaborative groups
Name [3] 359 0
North Eastern Metropolitan Integrated Cancer Service
Address [3] 359 0
Cancer Services Administration, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084
Country [3] 359 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5720 0
Austin Health Human Research ethics Committee
Ethics committee address [1] 5720 0
145 Studley Rd
Heidelberg VIC 3084
Ethics committee country [1] 5720 0
Australia
Date submitted for ethics approval [1] 5720 0
Approval date [1] 5720 0
Ethics approval number [1] 5720 0
Project 03163

Summary
Brief summary
This pilot study seeks to obtain preliminary data that addresses the questioon of whether psychological inteventions can improve coping for Cancer patients undergoing chemotherapy for the first time, which is often an uncomfortable process. From a mental health point of view "coping" is operationalised interms of depression, anxiety and perceived quality of life. The effect of the interventions on nausea - a common side effect of chemotherapy - is also being assessed. Also of interest is whether interventions requiring specific psychological training (i.e. cognitive behavioural therapy) add anything to the outcomes achieved by simple relaxation training which could be carried out by a wide range of health professionals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28799 0
Address 28799 0
Country 28799 0
Phone 28799 0
Fax 28799 0
Email 28799 0
Contact person for public queries
Name 11956 0
Prof Jeannette Milgrom
Address 11956 0
Department of Clinical and Health Psychology, Austin Hospital, Repatriation Campus, 300 Waterdale Rd, West Heidelberg VIC 3081
Country 11956 0
Australia
Phone 11956 0
(03) 94964496
Fax 11956 0
Email 11956 0
[email protected]
Contact person for scientific queries
Name 2884 0
Mr Stephen Malkin
Address 2884 0
Department of Clinical and Health Psychology, Austin Hospital, Repatriation Campus, 300 Waterdale Rd, West Heidelberg VIC 3081
Country 2884 0
Australia
Phone 2884 0
(03) 94964490
Fax 2884 0
Email 2884 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

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