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DEFINITIONS
Trial Review
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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
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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.
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Secondary ID [1]
282346
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Nil
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Universal Trial Number (UTN)
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Trial acronym
Coping-Together
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer - breast, prostate, colorectal (bowel) and melanoma
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Anxiety
288906
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Adjustment to cancer
288907
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Condition category
Condition code
Cancer
289257
289257
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0
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Other cancer types
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Mental Health
289258
289258
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0
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Anxiety
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Public Health
289259
289259
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286967
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Anxiety, patient's and partner's, as measured by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
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Assessment method [1]
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Timepoint [1]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [1]
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Depression, patient's and partner's, as measured by the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
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Assessment method [1]
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Timepoint [1]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [2]
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Distress, patient's and partner's, as measured by the Distress Thermometer
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Assessment method [2]
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Timepoint [2]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [3]
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Quality of life, as measured by the Assessment of Quality of Life (AQoL - 8).
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Assessment method [3]
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Timepoint [3]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [4]
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The Mishel's Uncertainty Scale has been removed from the study.
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Assessment method [4]
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Timepoint [4]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [5]
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Coping:
Individual coping, as measured by scores on the Brief COPE
Dyadic coping, as measured by scores on the Dyadic Coping Inventory.
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Assessment method [5]
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Timepoint [5]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [6]
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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)
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Assessment method [6]
302350
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Timepoint [6]
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At baseline, with follow-ups at 3 and 6 months
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Secondary outcome [7]
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Relationship satisfaction, as measured by the Dyadic Adjustment Scale (DAS)
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Assessment method [7]
302351
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Timepoint [7]
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At baseline, with follow-ups at 3 and 6 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, stratified by cancer type.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/05/2013
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Actual
25/06/2013
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Date of last participant enrolment
Anticipated
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Actual
8/10/2015
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Date of last data collection
Anticipated
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Actual
10/05/2016
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Sample size
Target
1200
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Accrual to date
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Final
130
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
2083
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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [4]
2085
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [5]
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The Canberra Hospital - Garran
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Recruitment hospital [6]
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Dubbo Base Hospital - Dubbo
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Recruitment hospital [7]
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Orange Health Service - Orange
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Recruitment hospital [8]
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Lake Macquarie Private Hospital - Gateshead
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Recruitment hospital [9]
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Wollongong Hospital - Wollongong
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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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
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Address
CONCERT - Psycho-Oncology Research Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
285894
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Country [1]
285894
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289126
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
289126
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Hunter New England Research Ethics and Governance Unit Locked Bag 1 New Lambton NSW 2305
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Ethics committee country [1]
289126
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Australia
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Date submitted for ethics approval [1]
289126
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Approval date [1]
289126
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02/11/2012
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Ethics approval number [1]
289126
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12/10/17/4.04
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Ethics committee name [2]
289127
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University of New South Wales Human Research Ethics Committee
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Ethics committee address [2]
289127
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UNSW Human Research Ethics Committee Grants Management Office Level 3, Rupert Myers Building South Wing UNSW Kensington Campus NSW 2052
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Ethics committee country [2]
289127
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Australia
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Date submitted for ethics approval [2]
289127
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Approval date [2]
289127
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06/12/2012
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Ethics approval number [2]
289127
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HC12671
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Ethics committee name [3]
289128
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University of Newcastle Human Research Ethis Committee
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Ethics committee address [3]
289128
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Research Services Research Integrity Unit The Chancellery The University of Newcastle Callaghan NSW 2308
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Ethics committee country [3]
289128
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Australia
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Date submitted for ethics approval [3]
289128
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Approval date [3]
289128
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05/02/2013
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Ethics approval number [3]
289128
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H-2013-0011
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Ethics committee name [4]
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Royal Adelaide Hospital
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Ethics committee address [4]
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Central Adelaide Local Health network Research Governance Office Level 3, IMVS South Building Frome Rd Adeliade SA 5000
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Ethics committee country [4]
290555
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Australia
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Date submitted for ethics approval [4]
290555
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Approval date [4]
290555
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29/01/2014
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Ethics approval number [4]
290555
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HREC/13/RAH/156
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Ethics committee name [5]
290556
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South Western Sydney Local Health District
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Ethics committee address [5]
290556
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Research and Ethics Office Locked Bag 7279 Liverpool BC NSW 1871
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Ethics committee country [5]
290556
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Australia
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Date submitted for ethics approval [5]
290556
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Approval date [5]
290556
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17/09/2013
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Ethics approval number [5]
290556
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SSA/13/LPOOL/204; SSA/13/LPOOL274; SSA/13/LPOOL/275
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Ethics committee name [6]
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Western NSW & Far West Local Health Districts
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Ethics committee address [6]
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Research Governance PO Box 143 Bathurst NSW 2795
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Ethics committee country [6]
291491
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Australia
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Date submitted for ethics approval [6]
291491
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Approval date [6]
291491
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26/06/2014
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Ethics approval number [6]
291491
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HREC/12/HNE/363, SSA Application no: SSA/13/GWAHS/80
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Ethics committee name [7]
294172
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ACT Health Human Research Ethics Committee
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Ethics committee address [7]
294172
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PO Box 11 Woden ACT 2606
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Ethics committee country [7]
294172
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Australia
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Date submitted for ethics approval [7]
294172
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Approval date [7]
294172
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29/01/2014
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Ethics approval number [7]
294172
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ETHLR.14.003
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Ethics committee name [8]
294173
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Western NSW and Far West Local Health Districts
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Ethics committee address [8]
294173
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Research Governance, PO box 143, Level 1, 230 Howick Street, Bathurst NSW 2795
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Ethics committee country [8]
294173
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Australia
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Date submitted for ethics approval [8]
294173
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Approval date [8]
294173
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26/06/2014
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Ethics approval number [8]
294173
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SSA/13/GWAHS/80
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Ethics committee name [9]
294174
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Illawarra Shoalhaven Local Health District/ University of Wollongong
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Ethics committee address [9]
294174
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Research Directorate, Wollongong Hospital, Block C, Level 8, LMB 8808, CMC NSW 2521
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Ethics committee country [9]
294174
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Australia
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Date submitted for ethics approval [9]
294174
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Approval date [9]
294174
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23/12/2014
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Ethics approval number [9]
294174
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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.
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Trial website
www.copingtogether.org.au Please note this site is only accessible to participants who have been provided with a study log-in
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Afaf Girgis
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Address
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CONCERT Translational Cancer Research Centre
Psycho-Oncology Resaerch Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
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Country
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Australia
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Phone
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+61 2 8738 9244
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Janelle Levesque
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Address
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CONCERT Translational Cancer Research Centre
Psycho-Oncology Resaerch Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
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Country
39331
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Australia
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Phone
39331
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+61 2 8738 9244 or 1800 104 597
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Fax
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Email
39331
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[email protected]
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Contact person for scientific queries
Name
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Afaf Girgis
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Address
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CONCERT Translational Cancer Research Centre
Psycho-Oncology Resaerch Group
Ingham Institute
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC, NSW, 1871
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Country
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Australia
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Phone
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+61 2 8738 9243
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Fax
39332
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Email
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[email protected]
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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.
Download to PDF