Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000448044
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
2/06/2010
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Date results provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting Optimal Outcomes in Mood through Psychosocial Therapies for cancer patients: a randomised trial
Scientific title
Application of tailored psychosocial therapies to reduce distress and depression in cancer patients: a randomised trial
Secondary ID [1] 251823 0
Nil
Universal Trial Number (UTN)
U1111-1115-0677
Trial acronym
PROMPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression in cancer patients 257420 0
Distress in cancer patients 257421 0
Risk of depression in cancer patients 257422 0
Condition category
Condition code
Mental Health 257569 257569 0 0
Depression
Cancer 257665 257665 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have low to mild distress or who have risk factors for becoming depressed will receive a self-directed resource suite which includes handbooks on coping with cancer, a relaxation CD, information about coping with stress and other information about topics such as sleep hygiene and exercise. Information is included about the availability of support through the Cancer Helpline.
Patients who have mild to moderate depression/distress and/or risk factors for becoming depressed and a HADS score of 8 to 21 inclusive will receive tailored psychosocial therapy, aligned with patient needs as identified on patient self-report on the Distress Thermometer.
The precise type of psychosocial therapy will vary depending on patient need, examples of which include:
i) Practical concerns such as about finances; difficulty with domestic tasks: Therapy may include referral to Social Work; clarification of concerns; structured problem-solving; challenging black and white thinking about the need to perform domestic tasks; re-assigning priorities.
ii) Family - concerns about children: Therapy components may include empathic listening; acknowledgment of concerns; explanation about children's needs; discussion about the benefits of maintaining routine; reassuring children that they have not caused the cancer.
iii) Emotional concerns, for example anxiety about chemotherapy: Therapy may include explanation and provision of information; identification of automatic thoughts; challenging negative cognitions; relaxation and guided imagery.
iv) Physical concerns such as pain: Therapy would include referral for medical review; exploration of concerns about pain; identifying and challenging misbeliefs e.g. about becoming dependent on analgesia or that use of morphine implies inevitably poor prognosis; relaxation and guided imagery.
v) Spiritual concerns such as shame about dependence, low sense of worth: Therapy would include dignity-conserving techniques e.g. exploration of past experiences, reflection on strengths; engaging in creative discussion about ways to feel in control; framing assistance as necessary to maintain dignity.
The psychosocial therapy will be delivered by health professionals from diverse backgrounds including nursing, radiation therapy or speech therapy who have undergone focused training. The training will be delivered through a structured self-directed educational manual, supplemented with a day-long skill development training session faciliated by one of the psychiatrist investigators at the specific Site. The duration of the training for participating health professionals will be approximately 10 weeks. During the delivery of the psychosocial therapy, all health professionals will participate in weekly clinical supervision conducted in group format with other participating health professionals at the respective Site, facilitated by one of the psychiatrist investigators, in order to monitor progress and ensure fidelity of the psychosocial intervention.
The therapy sessions will each be of maximum 30 minutes' duration, for a maximum of 4 sessions, delivered over 4 weeks. The therapy may be delivered face-to-face or by telephone depending on patient and health professional convenience. Patients receiving the psychosocial therapy will also receive the self-directed resource suite described above.
Intervention code [1] 256524 0
Other interventions
Intervention code [2] 256527 0
Treatment: Other
Comparator / control treatment
Patients who have no distress and no risk factors for the development of depression will continue to receive usual medical treatment and follow-up of their cancer. These patients will continue to have access to a variety of support services both at their treating hospital and in the community according to their needs and identification of concerns by their treating clinician. However these patients will not have any contact with the trained health professional other than in the course of routine clinical treatment.
Control group
Active

Outcomes
Primary outcome [1] 258494 0
Change in depression as measured by Hospital Anxiety and Depression Score (HADS)[Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983; 67:362-370]
Timepoint [1] 258494 0
Baseline and 10-week follow-up
Secondary outcome [1] 264284 0
Change in patient unmet needs as measured by Supportive Care Needs Survey - Short Form (SCNS-SF) [Bonevski B, Sanson-Fisher R, Girgis A et al. Evaluation of an instrument to assess the needs of patients with cancer. Cancer 2000; 88: 217-225]
Timepoint [1] 264284 0
Baseline and 10-week follow-up
Secondary outcome [2] 264285 0
Change in patient Quality of Life as measured by
Functional Assessment of Cancer Therapy (FACT-G). [Cella DF, Tulsky DS, Gray G. et al. Functional Assessment of Cancer Therapy (FACT) scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11: 570-579] and
EQ-5D [EuroQol Group. EuroQol?a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990; 16: 199-208]
Timepoint [2] 264285 0
Baseline and 10-week follow-up
Secondary outcome [3] 264286 0
Change in patient Demoralisation as measured by Demoralisation Scale [Kissane DW, Wein S, Love A et al. The Demoralization Scale: a report of its development and preliminary validation. Journal of Palliative Care 2004; 20: 269-76]
Timepoint [3] 264286 0
Baseline and 10 -week follow-up
Secondary outcome [4] 264287 0
Change in health professional psychological morbidity as measured by the General Health Questionnairre (GHQ). [Goldberg, D.P., Gater, R., Sartorius, N et al. The validity of two versions of the GHQ in the WHO study of mental illness in general health care. Psychological Medicine 1997; 27; 191-197]
Timepoint [4] 264287 0
Baseline and 10-week follow-up (completion of training) and
Completion of study.
The number of weeks from baseline to completion of the study varies for each Site, as this is a stepped wedge trial in which the various Sites are randomly allocated to deliver the Intervention. Thus for health professionals at Site 1, timepoints will be baseline, 10-week follow-up and 60 weeks after recruitment. For health professionals at the final Site to be randomised (Site 5), timepoints will be baseline, 10-week follow-up and 20 weeks after recruitment.
Secondary outcome [5] 264288 0
Change in health professional levels of stress and burnout as measured by the Maslach Burnout Inventory (MBI) [Maslach C, Jackson SE. The measurement of experienced burnout. Journal of Occupational Behaviour 1981; 2: 99-113]
Timepoint [5] 264288 0
Baseline and 10-week follow-up (completion of training) and
Completion of study.
The number of weeks from baseline to completion of the study varies for each Site, as this is a stepped wedge trial in which the various Sites are randomly allocated to deliver the Intervention. The intervention will be sequentially rolled out across Sites in random order over a period of 60 weeks. Thus for health professionals at Site 1, timepoints will be baseline, 10-week follow-up and 60 weeks after recruitment. For health professionals at the final Site to be randomised (Site 5), timepoints will be baseline, 10-week follow-up and 20 weeks after recruitment.

Eligibility
Key inclusion criteria
Patients eligible for this study must have a diagnosis of cancer and be attending any of the participating clinical Sites for medical review or treatment.
Aged 18 years or over
Consecutive patients attending outpatient oncology clinics at each Site
Are currently receiving active treatment for cancer OR
Have completed active treatment within the previous 2 months OR
Have been diagnosed with recurrent/advanced cancer within the previous 2 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to speak and read English; Receiving current specialised psychological treatment from a psychologist, psychiatrist, or other trained counsellor; Currently taking antidepressant medication; Health status precludes ability to complete questionnaires and participate in up to four (4) psychosocial Intervention sessions, and follow-up at 10 weeks; Recruited in any previous Epoch of this study (ie patients can only participate during one Epoch)

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)
This is a cluster-randomised stepped-wedge design randomised controlled trial (RCT). Clusters (Sites/hospitals) will be randomised progressively as the trial proceeds. Initially, all clusters will be assigned as control cluster, after which one cluster will be selected at random by the trial statistician, to be converted to an Intervention cluster. This process will continue until two clusters remain as control clusters. In the penultimate epoch, one of these will be randomly assigned as an intervention cluster. At the end of this epoch, the final cluster will be aware of its necessary conversion to the intervention. Thus, only at the last epoch, will the allocation not be concealed to the clusters. The first 20 consecutive patients admitted to every cluster will be assigned to the treatment group of the cluster at that epoch. Researchers and patients will be aware of the current cluster assignment at the time of enrolment. To minimise the risk of selective enrolment, we will record details of all non-consenting patients as well as consenting patients. Every consecutive patient attending the outpatient oncology department at each Site will be screened for eligibility and enrolled if eligible and consenting. Careful documentation of outpatient attendance, subsequent enrolments and consent interviews will ensure that no patient is “selected” for inclusion or exclusion from the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clusters will be randomised using a sequence of computer-generated pseudo-random numbers generated by the statistics program Stata Rel 11.0. or later.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The design for this randomised study is a stepped-wedge cluster design, a type of crossover design in which different clusters (the Clinical Sites) cross over in one direction only, from Control to Training then Intervention. The Intervention is sequentially rolled-out across Sites in random order over a number of time periods, so that at the conclusion of the study, all Sites will have received Training and be providing the Intervention delivered by a recruited Health Professional who has received training at that site
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2011
Actual
14/03/2011
Date of last participant enrolment
Anticipated
Actual
23/11/2012
Date of last data collection
Anticipated
Actual
10/05/2013
Sample size
Target
600
Accrual to date
Final
467
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 2902 0
4029
Recruitment postcode(s) [2] 2903 0
Site withdrawn from studyon 29.3.12
Recruitment postcode(s) [3] 2904 0
3800
Recruitment postcode(s) [4] 2905 0
2300
Recruitment postcode(s) [5] 2906 0
4066

Funding & Sponsors
Funding source category [1] 257013 0
Charities/Societies/Foundations
Name [1] 257013 0
beyondblue
Country [1] 257013 0
Australia
Primary sponsor type
Individual
Name
Jane Turner
Address
Department of Psychiatry,
K Floor,
Mental Health Centre,
HERSTON. QLD. 4029.
Country
Australia
Secondary sponsor category [1] 256272 0
University
Name [1] 256272 0
University of Queensland
Address [1] 256272 0
Research Services,
University of Queensland.
St Lucia. QLD. 4072.
Country [1] 256272 0
Australia
Other collaborator category [1] 1282 0
Individual
Name [1] 1282 0
Brian Kelly
Address [1] 1282 0
University of Newcastle and John Hunter Hospital
Locked Bag 6005,
Forest Road,
Callaghan. NSW. 2308.
Country [1] 1282 0
Australia
Other collaborator category [2] 1283 0
Individual
Name [2] 1283 0
David Clarke
Address [2] 1283 0
Monash Medical Centre,
247 Clayton Road,
Clayton. VIC. 3168
Country [2] 1283 0
Australia
Other collaborator category [3] 1284 0
Individual
Name [3] 1284 0
Patsy Yates
Address [3] 1284 0
School of Nursing,
Queensland University of Technology,
Victoria Park Road,
Kelvin Grove. QLD. 4059.
Country [3] 1284 0
Australia
Other collaborator category [4] 1285 0
Individual
Name [4] 1285 0
Sanchia Aranda
Address [4] 1285 0
Cancer Institute NSW, University of Melbourne and Peter MacCallum Cancer Center, 243 Queensberry Street, Carlton. VIC. 3053.
Country [4] 1285 0
Australia
Other collaborator category [5] 1286 0
Individual
Name [5] 1286 0
Damien Jolley
Address [5] 1286 0
Monash University
Locked Bag 29,
43-51 Kanook Gve.,
Clayton. VIC. 3168.
Country [5] 1286 0
Australia
Other collaborator category [6] 1287 0
Individual
Name [6] 1287 0
Suzanne Chambers
Address [6] 1287 0
Professor of Preventative Health
Griffith Health Institute
Griffith University QLD 4222
Country [6] 1287 0
Australia
Other collaborator category [7] 1288 0
Individual
Name [7] 1288 0
Maryanne Hargraves
Address [7] 1288 0
Haematology and Oncology Clincs of Australia, PO Box 1879, Milton. QLD. 4064.
Country [7] 1288 0
Australia
Other collaborator category [8] 1289 0
Individual
Name [8] 1289 0
Lisa McFadyen
Address [8] 1289 0
Melanoma Patient support Group
Po Box 175,
Red Hill. QLD. 4059.
Country [8] 1289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259031 0
Human Research Ethics Committee
Ethics committee address [1] 259031 0
Ethics committee country [1] 259031 0
Australia
Date submitted for ethics approval [1] 259031 0
20/07/2010
Approval date [1] 259031 0
26/08/2010
Ethics approval number [1] 259031 0
HREC/10/QRBW/316
Ethics committee name [2] 260066 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 260066 0
Ethics committee country [2] 260066 0
Australia
Date submitted for ethics approval [2] 260066 0
Approval date [2] 260066 0
09/09/2010
Ethics approval number [2] 260066 0
2010001130

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31194 0
A/Prof Jane Turner
Address 31194 0
Department of Psychiatry, School of Medicine, University of Queensland, K Floor, Mental Health Centre HERSTON. QLD. 4029
Country 31194 0
Australia
Phone 31194 0
+61 7 3365 5154
Fax 31194 0
Email 31194 0
jane.turner@uq.edu.au
Contact person for public queries
Name 14441 0
Jane Turner
Address 14441 0
Discipline of Psychiatry
K Floor, Mental Health Centre
HERSTON. QLD. 4029
Country 14441 0
Australia
Phone 14441 0
+61 7 3365 5154
Fax 14441 0
+61 7 3365 5488
Email 14441 0
jane.turner@uq.edu.au
Contact person for scientific queries
Name 5369 0
Jane Turner
Address 5369 0
Discipline of Psychiatry
K Floor, Mental Health Centre
HERSTON. QLD. 4029
Country 5369 0
Australia
Phone 5369 0
+61 7 3365 5154
Fax 5369 0
+61 7 3365 5488
Email 5369 0
jane.turner@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseExamining clinical supervision as a mechanism for changes in practice: a research protocol.2014https://dx.doi.org/10.1111/jan.12211
N.B. These documents automatically identified may not have been verified by the study sponsor.