Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000018213
Ethics application status
Approved
Date submitted
5/11/2008
Date registered
9/01/2009
Date last updated
28/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of an orientation program conducted by a multidisciplinary team on self-efficacy and anxiety of newly registered cancer patients: A randomised controlled trial
Scientific title
The effects of an orientation program conducted by a multidisciplinary team on self-efficacy and anxiety of newly registered cancer patients: A randomised controlled trial
Secondary ID [1] 280562 0
N/A
Universal Trial Number (UTN)
Trial acronym
MOP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 3926 0
Condition category
Condition code
Cancer 4120 4120 0 0
Breast
Cancer 4121 4121 0 0
Lung - Non small cell
Cancer 4122 4122 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a structured orientation program conducted by a multidisciplinary health care team with the main aims to let patients familiarise themselves with the treatment centre, health professionals and treatment. This orientation will be conducted as a single time 90 minute face to face workshop in a group.
Intervention code [1] 3644 0
Other interventions
Comparator / control treatment
Usual care (without orientation program)
Control group
Active

Outcomes
Primary outcome [1] 5010 0
Mood (Profile of Mood State)
Timepoint [1] 5010 0
Baseline which is the first consultation, Time 2 which is the day of the first treatment, Time 3 which is one week after the first treatment commenced
Primary outcome [2] 5011 0
Anxiety (State Trait Anxiety Inventory)
Timepoint [2] 5011 0
Baseline which is the first consultation, Time 2 which is the day of the first treatment, Time 3 which is one week after the first treatment commenced
Primary outcome [3] 5012 0
Self-efficacy (The communication and attitudinal self-efficacy scale for cancer)
Timepoint [3] 5012 0
Baseline which is the first consultation, Time 2 which is the day of the first treatment, Time 3 which is one week after the first treatment commenced
Secondary outcome [1] 8459 0
Important information received (Yes/No)
Timepoint [1] 8459 0
Baseline which is the first consultation, Time 2 which is the day of the first treatment, Time 3 which is one week after the first treatment commenced

Eligibility
Key inclusion criteria
1. Cancer patients who are newly registered to the Royal Brisbane and Women's Hospital.
2. Patients who has a definitive diagnosis of breast cancer, lung cancer or Non-Hodgkin lymphoma
Patients who have not received any kind of formal education about cancer.
3. Patients who will be undergoing radiation therapy or chemotherapy
4. Patients who can read and write English
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who is unable to consent
2. Patients who is unable to read and write English
3. Patients who previous receive any form of formal cancer education
4. Patients who have previous cancer treatments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After the research nurse has obtained the patient’s consent, he/she will telephone a contact who is independent of the recruitment process for allocation concealment. Subsequently, baseline data will be collected. All questionnaires are self-administered by patients. Therefore, the research nurse will not have involvement in completing these questionnaires.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation will be performed by a computer generated random number list prepared by an investigator who has no clinical involvement in the trial. Stratification by primary cancer diagnosis group will also be carried out.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 1283 0
4029

Funding & Sponsors
Funding source category [1] 4108 0
Self funded/Unfunded
Name [1] 4108 0
Country [1] 4108 0
Primary sponsor type
Hospital
Name
Cancer Care Services
Address
Cancer Care Services, Royal Brisbane and Women's Hospital, Burtterfield Street, Herston, Q4029
Country
Australia
Secondary sponsor category [1] 3700 0
None
Name [1] 3700 0
Address [1] 3700 0
Country [1] 3700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6182 0
Ethics committee address [1] 6182 0
Ethics committee country [1] 6182 0
Date submitted for ethics approval [1] 6182 0
12/11/2008
Approval date [1] 6182 0
Ethics approval number [1] 6182 0

Summary
Brief summary
There are 283 new outpatients each month registered to cancer care services at the Royal Brisbane and Women’s Hospital (RBWH). The first visit of oncology patients and families to an outpatient cancer centre often causes intense anxiety and negative emotions. Recent nursing initiatives in cancer care services include a multidisciplinary orientation program for the head and neck cancer patients. This multidisciplinary orientation program will be extended to all newly registered cancer patients in 2009. This pilot study will evaluate the effects of the multi-disciplinary orientation program on the levels of self-efficacy and anxiety of newly registered cancer patients at the RBWH.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29095 0
Address 29095 0
Country 29095 0
Phone 29095 0
Fax 29095 0
Email 29095 0
Contact person for public queries
Name 12252 0
Raymond Chan
Address 12252 0
Level 2, Blg 34, Royal Brisbane Women's Hospital, Butterfield Street, Herston Q 4029
Country 12252 0
Australia
Phone 12252 0
+61 7 3636 5833
Fax 12252 0
+61 7 3636 1557
Email 12252 0
[email protected]
Contact person for scientific queries
Name 3180 0
Raymond Chan
Address 3180 0
Level 2, Blg 34, Royal Brisbane Women's Hospital, Butterfield Street, Herston Q 4029
Country 3180 0
Australia
Phone 3180 0
+61 7 3636 5833
Fax 3180 0
+61 7 3636 1557
Email 3180 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.