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Trial registered on ANZCTR


Registration number
ACTRN12613000491763
Ethics application status
Approved
Date submitted
17/04/2013
Date registered
2/05/2013
Date last updated
27/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Coping-Together: A study to help couples manage a recent cancer diagnosis
Scientific title
Coping-Together: A randomised controlled trial of the impact of a self-directed coping skills intervention on patients' with cancer and their partners' anxiety.
Secondary ID [1] 282346 0
Nil
Universal Trial Number (UTN)
Trial acronym
Coping-Together
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer - breast, prostate, colorectal (bowel) and melanoma 288905 0
Anxiety 288906 0
Adjustment to cancer 288907 0
Condition category
Condition code
Cancer 289257 289257 0 0
Other cancer types
Mental Health 289258 289258 0 0
Anxiety
Public Health 289259 289259 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Descriptions of intervention(s) / exposure: The intervention group receive a self-directed illness self-management and coping skills training intervention, Coping-Together that aims to provide couples with the resources they need to confront the challenges posed by a cancer diagnosis. A holistic foundation underpins Coping-Together, including strategies to manage physical, social, psychological and existential cancer-related challenges. The core component of Coping-Together is a series of 6 booklets, each addressing one of the following challenges: 1) communicating with health care professionals, 2) making treatment-related decisions, 3) managing symptoms and side effects of treatment, 4) managing worries and emotions, 5) supporting your partner, and 6) accessing community support services. The Coping-Together booklets are complemented by multi-media resources, including a DVD, Relaxation CD and a website. The duration of the trial is 6 months, during which time participants (regardless of group allocation) will be asked to use the information resources they have been sent, complete follow-up surveys and participate in an orientation phone call/interview (duration approximately 5-10 minutes) to discuss their intended use of the resource material.
The Coping-Together group also receives the Minimal Ethical Care control materials. In regards to resource use, couples are asked to use the resources as much as they can, however it is acknowledged that not all content will apply to every participant. It is therefore expected that the time spent using the intervention materials will vary from participant to participant.
Intervention code [1] 286967 0
Behaviour
Comparator / control treatment
Minimal Ethical Care: Couples randomly assigned to this group will receive their standard medical care, as well as a booklet from the Cancer Council NSW 'Understanding Cancer' series, the Caring for Someone with Cancer booklet, and a flyer for the Cancer Council helpline. Participants in this group also receive the orientation call as per the Coping-Together groups.
Control group
Active

Outcomes
Primary outcome [1] 289370 0
Anxiety, patient's and partner's, as measured by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
Timepoint [1] 289370 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [1] 302345 0
Depression, patient's and partner's, as measured by the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Timepoint [1] 302345 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [2] 302346 0
Distress, patient's and partner's, as measured by the Distress Thermometer
Timepoint [2] 302346 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [3] 302347 0
Quality of life, as measured by the Assessment of Quality of Life (AQoL - 8).
Timepoint [3] 302347 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [4] 302348 0
The Mishel's Uncertainty Scale has been removed from the study.
Timepoint [4] 302348 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [5] 302349 0
Coping:
Individual coping, as measured by scores on the Brief COPE
Dyadic coping, as measured by scores on the Dyadic Coping Inventory.
Timepoint [5] 302349 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [6] 302350 0
Patient and Partner Self-efficacy and empowerment, as measured by: Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE-C), Health Education Impact Questionairre (heiQ, patients only) and Caregiver Empowerment Scale (partners only)
Timepoint [6] 302350 0
At baseline, with follow-ups at 3 and 6 months
Secondary outcome [7] 302351 0
Relationship satisfaction, as measured by the Dyadic Adjustment Scale (DAS)
Timepoint [7] 302351 0
At baseline, with follow-ups at 3 and 6 months

Eligibility
Key inclusion criteria
a) Diagnosed within the past 4 months with Stage I, II or III breast, prostate, or colorectal (bowel) cancer, or melanoma
b) Receiving, or planning to receive treatment
c) Partner willing to participate in the study
d) Patient or partner scoring 4+ on the Distress Thermometer
e) Sufficiently fluent in English and cognitively able to complete surveys.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a)Identfied by health care professionals as not being well enough to participate in the study, which might include but is not limited to, concurrent psychiatric conditions.
b) Patient previously diagnosed with cancer
c) Partner not willing to participate

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)
Recruitment of participants: It is anticipated the the majority of recruitment will be facilitated by the treating cinician, who will identify eligible patients and invite them to participate in the study. The study will also be promoted through media and support organisations, and therefore there is the possibility that patients or partner may self-refer themselves to the study.

Allocation to study group: Random allocation using a concealed randomisation schedule generated via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, stratified by cancer type.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 2082 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 2083 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 2084 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 2085 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [5] 2839 0
The Canberra Hospital - Garran
Recruitment hospital [6] 2840 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [7] 2841 0
Orange Health Service - Orange
Recruitment hospital [8] 5048 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [9] 5049 0
Wollongong Hospital - Wollongong

Funding & Sponsors
Funding source category [1] 287122 0
Government body
Name [1] 287122 0
National Health and Medical Research Council (NHMRC)
Address [1] 287122 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 287122 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Faculty of Medicine, South West Sydney Clinical School, CONCERT Translational Cancer Research Centre, Ingham Institute for Applied Medical Research
Address
CONCERT - Psycho-Oncology Research Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
Country
Australia
Secondary sponsor category [1] 285894 0
None
Name [1] 285894 0
Address [1] 285894 0
Country [1] 285894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289126 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289126 0
Hunter New England Research Ethics and Governance Unit
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 289126 0
Australia
Date submitted for ethics approval [1] 289126 0
Approval date [1] 289126 0
02/11/2012
Ethics approval number [1] 289126 0
12/10/17/4.04
Ethics committee name [2] 289127 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [2] 289127 0
UNSW Human Research Ethics Committee
Grants Management Office
Level 3, Rupert Myers Building South Wing
UNSW Kensington Campus
NSW 2052
Ethics committee country [2] 289127 0
Australia
Date submitted for ethics approval [2] 289127 0
Approval date [2] 289127 0
06/12/2012
Ethics approval number [2] 289127 0
HC12671
Ethics committee name [3] 289128 0
University of Newcastle Human Research Ethis Committee
Ethics committee address [3] 289128 0
Research Services
Research Integrity Unit
The Chancellery
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [3] 289128 0
Australia
Date submitted for ethics approval [3] 289128 0
Approval date [3] 289128 0
05/02/2013
Ethics approval number [3] 289128 0
H-2013-0011
Ethics committee name [4] 290555 0
Royal Adelaide Hospital
Ethics committee address [4] 290555 0
Central Adelaide Local Health network
Research Governance Office
Level 3, IMVS South Building
Frome Rd
Adeliade SA 5000
Ethics committee country [4] 290555 0
Australia
Date submitted for ethics approval [4] 290555 0
Approval date [4] 290555 0
29/01/2014
Ethics approval number [4] 290555 0
HREC/13/RAH/156
Ethics committee name [5] 290556 0
South Western Sydney Local Health District
Ethics committee address [5] 290556 0
Research and Ethics Office
Locked Bag 7279
Liverpool BC NSW 1871
Ethics committee country [5] 290556 0
Australia
Date submitted for ethics approval [5] 290556 0
Approval date [5] 290556 0
17/09/2013
Ethics approval number [5] 290556 0
SSA/13/LPOOL/204; SSA/13/LPOOL274; SSA/13/LPOOL/275
Ethics committee name [6] 291491 0
Western NSW & Far West Local Health Districts
Ethics committee address [6] 291491 0
Research Governance
PO Box 143
Bathurst NSW 2795
Ethics committee country [6] 291491 0
Australia
Date submitted for ethics approval [6] 291491 0
Approval date [6] 291491 0
26/06/2014
Ethics approval number [6] 291491 0
HREC/12/HNE/363, SSA Application no: SSA/13/GWAHS/80
Ethics committee name [7] 294172 0
ACT Health Human Research Ethics Committee
Ethics committee address [7] 294172 0
PO Box 11
Woden ACT 2606
Ethics committee country [7] 294172 0
Australia
Date submitted for ethics approval [7] 294172 0
Approval date [7] 294172 0
29/01/2014
Ethics approval number [7] 294172 0
ETHLR.14.003
Ethics committee name [8] 294173 0
Western NSW and Far West Local Health Districts
Ethics committee address [8] 294173 0
Research Governance, PO box 143, Level 1, 230 Howick Street, Bathurst NSW 2795
Ethics committee country [8] 294173 0
Australia
Date submitted for ethics approval [8] 294173 0
Approval date [8] 294173 0
26/06/2014
Ethics approval number [8] 294173 0
SSA/13/GWAHS/80
Ethics committee name [9] 294174 0
Illawarra Shoalhaven Local Health District/ University of Wollongong
Ethics committee address [9] 294174 0
Research Directorate, Wollongong Hospital, Block C, Level 8, LMB 8808, CMC NSW 2521
Ethics committee country [9] 294174 0
Australia
Date submitted for ethics approval [9] 294174 0
Approval date [9] 294174 0
23/12/2014
Ethics approval number [9] 294174 0

Summary
Brief summary
This study will test the efficacy of Coping-Together – a couple-based self-directed, coping skills training intervention. It is anticipated that using the proposed Coping-Together skills will be associated with couples experiencing less anxiety.

Who is it for?
You may be eligible for the study if you have recently been diagnosed with Stage I, II or III breast, prostate or colorectal (bowel) cancer, or melanoma and are currently receiving or planning to receive treatment. Your partner must also be willing to participate and you must both be able to understand and complete surveys.

Trial details:
You will be randomised to one of two treatment conditions, either the Coping-Together intervention or to the Minimal Ethical Care condition. The purpose of the study is to test the suitability of the information resources and assess which condition enhances illness adjustment and coping with cancer. All groups will be supplied with cancer and coping information, which participants work through at their own pace.

What are you being asked to do?
To participate in this study you will need to complete 4 surveys and receive an orientation call from research staff over a 6 month period. You are also asked to use the information resources provided as much as possible.
Trial website
www.copingtogether.org.au
Please note this site is only accessible to participants who have been provided with a study log-in
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39330 0
Prof Afaf Girgis
Address 39330 0
CONCERT Translational Cancer Research Centre
Psycho-Oncology Resaerch Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
Country 39330 0
Australia
Phone 39330 0
+61 2 8738 9244
Fax 39330 0
Email 39330 0
afaf.girgis@unsw.edu.au
Contact person for public queries
Name 39331 0
Dr Janelle Levesque
Address 39331 0
CONCERT Translational Cancer Research Centre
Psycho-Oncology Resaerch Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
Country 39331 0
Australia
Phone 39331 0
+61 2 8738 9244 or 1800 104 597
Fax 39331 0
Email 39331 0
j.levesque@unsw.edu.au
Contact person for scientific queries
Name 39332 0
Prof Afaf Girgis
Address 39332 0
CONCERT Translational Cancer Research Centre
Psycho-Oncology Resaerch Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
Country 39332 0
Australia
Phone 39332 0
+61 2 8738 9243
Fax 39332 0
Email 39332 0
afaf.girgis@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary