Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000428561
Ethics application status
Approved
Date submitted
17/03/2015
Date registered
6/05/2015
Date last updated
6/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Services Evaluation Pilot: Promoting an improved patient experience in gynaecological cancer care through supportive care screening and intervention.
Scientific title
In women with a diagnosis of gynaecological cancer, what is the benefit of additional supportive care compared to standard supportive care screening, as assessed by patient experience questionnaires and SF-12 scores.

Secondary ID [1] 286369 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecological cancer 294509 0
Mental health 294510 0
Condition category
Condition code
Cancer 294813 294813 0 0
Ovarian and primary peritoneal
Cancer 294814 294814 0 0
Cervical (cervix)
Mental Health 295121 295121 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. An initial brief psychosocial assessment and intervention based on a semi-structured interview and recorded in the form of an Eco-map. This involves a face to face session with one of our researchers (a social work student) exploring current concerns in patients' lives that may be impacting on their cancer diagnosis, guided by a questionnaire.
The intervention is administered when the patient is admitted to hospital, if they are undergoing surgery, or at a chemotherapy appointment, if they are undergoing chemotherapy.
2. Six follow up phone calls, occurring at weekly intervals. This is administered by the same researcher who conducts the face-to-face interviews to see how patients are adjusting at home after their time in hospital, and how they have been dealing with any psychosocial stressors. They can last 5-10 minutes.
3. Two additional eco-maps, occurring with the third and last phone calls
4. At the time of the final telephone call, the Patient Experience questionnaire and follow up SF-36 will be administered
Intervention code [1] 291431 0
Early detection / Screening
Comparator / control treatment
Standard hospital supportive care screening tools. This is a screening distress thermometer which is administered by the nurses; it briefly covers family, emotional and physical symptoms with yes and no questions.
This is administered at a gynae-oncology clinic visit prior to treatment commencing.
Control group
Active

Outcomes
Primary outcome [1] 294573 0
Patient experience score
Timepoint [1] 294573 0
3-6 months post initial treatment (either surgery or chemotherapy)
Primary outcome [2] 294574 0
SF-12 score - to assess patients' quality of life
Timepoint [2] 294574 0
3-6 months post initial treatment (either surgery or chemotherapy)
Primary outcome [3] 294575 0
CHIERS Eco-mapping score (intervention group)
Timepoint [3] 294575 0
At the time of the delivery of the intervention i.e. at the commencement of treatment. This could be days-weeks post randomisation, depending on when surgery or chemotherapy is planned.
Secondary outcome [1] 313640 0
Treatment completion data - to assess whether patient's follow their intended treatment trajectory (i.e. do they complete surgery and chemotherapy if that is what was planned)
Timepoint [1] 313640 0
3-6 months post initial recruitment

Eligibility
Key inclusion criteria
1. New diagnosis of any gynaecological cancer
2. Undergoing treatment at the Royal Women’s Hospital
3. Age greater than or equal to 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age less than 18 years old
2. Language other than English

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)
Eligible participants are identified and recruited from clinics by research nurses. A randomisation schedule has been generated, and sealed in opaque envelopes (allocation concealment). Each subsequently recruited patient is given the next sealed envelope containing the next randomisation number, which corresponds to either the intervention or control group. The patient is blind to the allocation process. The research staff are not blind to the allocation process and are aware to which group the patient has been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence generation using excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/09/2014
Actual
22/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3568 0
The Royal Women's Hospital - Parkville

Funding & Sponsors
Funding source category [1] 290939 0
Government body
Name [1] 290939 0
Department of Health
Country [1] 290939 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan Street
Parkville
VIC
3010
Country
Australia
Secondary sponsor category [1] 289624 0
Hospital
Name [1] 289624 0
Royal Women's Hospital
Address [1] 289624 0
20 Flemington Road, Parkville VIC 3052
Country [1] 289624 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292543 0
RWH Human Research Ethics Committee
Ethics committee address [1] 292543 0
20 Flemington Road, Parkville VIC 3052
Ethics committee country [1] 292543 0
Australia
Date submitted for ethics approval [1] 292543 0
Approval date [1] 292543 0
29/05/2014
Ethics approval number [1] 292543 0
14/08

Summary
Brief summary
This study aims to examine the impact of supportive care screening and follow up on patients being treated at the Royal Women’s Hospital for gynaecological cancer.

Who is it for?
You may be eligible to join this study if you are a female aged 18 years or above who has a new diagnosis of gynaecological cancer for which you are undergoing treatment at the Royal Women’s Hospital.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the standard hospital supportive care screening tools. Participants in the other group will receive an 'enhanced model of supportive care screening'. This incorporates a single supportive care intervention where the participant has a face-to-face conversation with one of our researchers regarding psychosocial stressors that may be impacting on the patient's cancer diagnosis and what can be done to alleviate some of those stressors.

All participants will be asked to complete some questionnaires between 3-6 months post enrolment in order to evaluate their patient experience and quality of life. The study will also audit the process of the patient treatment pathway and review modifiable and non-modifiable factors in the patient commencing in, remaining in, and completing treatment, and describe any complexities arising from this process. Furthermore, it is hoped that this project will provide evidence to inform future psychosocial practices and evidence based guidelines within gynaecological cancer care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55842 0
A/Prof Lynette Joubert
Address 55842 0
Department of Social Work
The University of Melbourne
Alan Gilbert Building
161 Barry Street
Carlton
Vic
3053
Country 55842 0
Australia
Phone 55842 0
+61383449417
Fax 55842 0
Email 55842 0
[email protected]
Contact person for public queries
Name 55843 0
Dr Shireen Bhatt
Address 55843 0
Department of Social Work
The University of Melbourne
Alan Gilbert Building
161 Barry Street
Carlton
Vic
3053
Country 55843 0
Australia
Phone 55843 0
+61429854359
Fax 55843 0
Email 55843 0
[email protected]
Contact person for scientific queries
Name 55844 0
A/Prof Lynette Joubert
Address 55844 0
Department of Social Work
The University of Melbourne
Alan Gilbert Building
161 Barry Street
Carlton
Vic
3053
Country 55844 0
Australia
Phone 55844 0
+61383449417
Fax 55844 0
Email 55844 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.