Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000438954
Ethics application status
Approved
Date submitted
28/04/2011
Date registered
28/04/2011
Date last updated
7/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Coping-Together: A feasibility study of a novel, self-directed supportive care intervention to enhance illness adjustment of couples affected by prostate cancer.
Scientific title
A randomised controlled study of the illness adjustment of couples affected by prostate cancer using 'Coping- Together', a self-directed supportive care intervention, compared to couples receiving minimal ethical care.
Secondary ID [1] 259948 0
Nil
Universal Trial Number (UTN)
Trial acronym
PAct: Partners in Action
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 265569 0
Anxiety 265570 0
Couples' adjustment to cancer 265580 0
Condition category
Condition code
Cancer 265715 265715 0 0
Prostate
Mental Health 265716 265716 0 0
Anxiety
Public Health 265725 265725 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coping-Together takes on a holistic approach to coping with cancer by including strategies to manage physical, social, psychological, and existential cancer-related challenges. The key component of Coping-Together is a series of four booklets, which translate the most up-to-date research on effective, practical coping strategies and render it readily available to couples. Each booklet addresses one of the following challenges: 1) symptom management, 2) communicating effectively with health care professionals, 3) supporting your partner, and 4) managing worries and emotions. For each challenge, specific coping strategies are proposed, including a step-by-step guide to mindfulness and muscle relaxation, practical self-care tips to manage side effects, using a question prompt list to improve communication with health care professionals, and worksheets to encourage joint problem-solving. Multiple coping strategies are presented to couples to facilitate a personalised approach, where couples can ‘pick and choose’ and apply those that most closely correspond to their needs. Also, the booklets contain information about additional health care resources that can contribute to optimal coping and illness adjustment, including the type of support that can be expected from different members of their health care team. The Coping-Together booklets are complemented by electronic media, including a relaxation CD and 'coping coach' DVD, which features content from the ‘communicating effectively with health care professionals’ booklet. Participants will be able to use any or all of these resources at their own discretion and pace prior to collection of the outcome data, which will be 2 months following baseline measurements.
Intervention code [1] 264359 0
Behaviour
Comparator / control treatment
Minimal ethical care (MEC): Couples will receive usual oncology and follow-up care, as well as a booklet(s) from the Cancer Council NSW 'Understanding Cancer Series'. These participants will receive fortnightly follow-up phone calls from research staff over a 2 month period following baseline measurements.
Control group
Active

Outcomes
Primary outcome [1] 266480 0
Scores on the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A).
Timepoint [1] 266480 0
At baseline and at 2 months post-baseline.
Secondary outcome [1] 273852 0
Cancer-specific distress as determined by scores on the Impact of Event Scale - Revised (IES-R).
Timepoint [1] 273852 0
At baseline and at 2 months post-baseline.
Secondary outcome [2] 273853 0
Depression as determined by scores on the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D).
Timepoint [2] 273853 0
At baseline and at 2 months post-baseline.
Secondary outcome [3] 273854 0
Quality of life as determined by scores on the Assessment of Quality of Life (AQoL).
Timepoint [3] 273854 0
At baseline and at 2 months post-baseline.
Secondary outcome [4] 273855 0
Relationship satisfaction as determined by scores on the Dyadic Adjustment Scale short-form (DAS-SF).
Timepoint [4] 273855 0
At baseline and at 2 months post-baseline.
Secondary outcome [5] 273856 0
Appraisal of caregiving (by cancer patients' partners) as determined by scores on the Appraisal of Caregiving Scale (ACS) and Appraisal of illness (by cancer patients) as determined by The Cognitive Appraisal of Health Scale and Uncertainty in Illness Scale.
Timepoint [5] 273856 0
At baseline and at 2 months post-baseline.
Secondary outcome [6] 273857 0
Self-efficacy, as determined by the Self-Efficacy Scale and the Communication and Attitudinal Self-Efficacy Scale for cancer
Timepoint [6] 273857 0
At baseline and at 2 months post-baseline.
Secondary outcome [7] 273858 0
Dyadic coping as determined by scores on the Dyadic Coping Scale.
Timepoint [7] 273858 0
At baseline and at 2 months post-baseline.
Secondary outcome [8] 273859 0
Individual coping, as determined by scores on the Brief COPE questionnnaire, Social Problem-Solving Inventory, the adapted Communicate With Physician scale, and Mental Stress Management/Relaxation Techniques
scale.
Timepoint [8] 273859 0
At baseline and at 2 months post-baseline.

Eligibility
Key inclusion criteria
a) Recently diagnosed with a primary, early-stage prostate cancer,
b) Receiving/planning to receive treatment,
c) Score 4+ on Distress Thermometer (DT),
d) Partner willing to participate in the study, and
e) Sufficiently fluent in English and cognitively able to complete surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Identified by health care professionals as not being well enough to participate in study, which might include, but is not limited to, concurrent psychiatric conditions. 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 that the majority of recruitment will be facilitated by urologists, who will identify eligible patients and invite them to participate in the study. There is also capacity, through study promotion and advertisements, for interested persons to contact the research team directly.

Allocating treatment:
Allocation concealed by utilising central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by referring urologist.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
30/01/2012
Actual
20/02/2012
Date of last participant enrolment
Anticipated
Actual
30/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 3906 0
2300
Recruitment postcode(s) [2] 3907 0
5000
Recruitment postcode(s) [3] 3908 0
2290
Recruitment postcode(s) [4] 3909 0
2305

Funding & Sponsors
Funding source category [1] 264830 0
Charities/Societies/Foundations
Name [1] 264830 0
Clinical Oncological Society of Australia
Country [1] 264830 0
Australia
Funding source category [2] 264962 0
Commercial sector/Industry
Name [2] 264962 0
Sanofi-aventis
Country [2] 264962 0
Australia
Primary sponsor type
University
Name
The University of New South Wales, Faculty of Medicine, South Western Sydney Clinical School, Ingham Institute for Applied Medical Research
Address
Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, Faculty of Medicine
The University of New South Wales
Locked Bag 7103 LIVERPOOL BC NSW 1871
Country
Australia
Secondary sponsor category [1] 263936 0
None
Name [1] 263936 0
Address [1] 263936 0
Country [1] 263936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266799 0
Human Research Ethics Committee University of Newcastle
Ethics committee address [1] 266799 0
The University of Newcastle Human Research Ethics Committee
Research Services, Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
CALLAGHAN NSW 2308
Ethics committee country [1] 266799 0
Australia
Date submitted for ethics approval [1] 266799 0
28/02/2011
Approval date [1] 266799 0
29/04/2011
Ethics approval number [1] 266799 0
H-2011-0048
Ethics committee name [2] 286526 0
Human Research Ethics Committee University of New SOuth Wales
Ethics committee address [2] 286526 0
UNSW Grants Management Office
Rupert Myers Building, Level 3 (M15)

The University of New South Wales NSW 2052
Ethics committee country [2] 286526 0
Australia
Date submitted for ethics approval [2] 286526 0
Approval date [2] 286526 0
24/11/2011
Ethics approval number [2] 286526 0
HC11468

Summary
Brief summary
This study aims to test the feasibility of providing a Coping-Together self-directed supportive care intervention to couples affected by prostate cancer. It is anticipated that using the proposed Coping-Together skills will be primarily associated with couples experiencing less anxiety.

Who is it for?
You may be eligible for this study if you have recently been diagnosed with a primary, early-stage prostate cancer, are currently receiving or planning to receive treatment, gain a score of 4 or above on a Distress Thermometer (DT) measurement, have a partner who is willing to participate in the study, and you are both able to understand and complete feedback surveys on your level of care and support.

Trial Details:
You will be randomised to one of two treatment arms in this study, either the Coping-Together (CT) arm, or to the Minimal Ethical Care (MEC) arm. The purpose of this study is to test which arm works better in couples to enhance your illness adjustment, along with how well the two of you are able to cope with your illness. Both arms involve being supplied with cancer and coping information; all or some of which you can use at your own pace. You will also receive fortnightly follow-up phone calls from research staff over a 2 month period following baseline measurements.
Trial website
Trial related presentations / publications
Lambert SD, Girgis A, Turner J, McElduff P, Kayser K, Vallentine P. A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design. Health and Quality of Life Outcomes, 2012, 10:119 (26 September 2012). doi:10.1186/1477-7525-10-119

Levesque, J. V., Lambert, S. D., Girgis, A., Turner, J., McElduff, P., Kayser, K., Vallentine, P., Chong, P., Sutherland P., & Wells, R. (2013). Do men with prostate cancer and their partners receive the information and support they need for optimal illness self-management?  Clinical Oncology Society of Australia  40th Annual Scientific Meeting, November 12th -14th  2013, Adelaide, South Australia. (Poster/mini-presentation)
Public notes

Contacts
Principal investigator
Name 32451 0
Dr Sylvie Lambert
Address 32451 0
Ingram School of Nursing
McGill University
Wilson Hall
3506 Sherbrooke St
Montreal, Quebec H3A2A7
Country 32451 0
Canada
Phone 32451 0
+1 514 797 3762
Fax 32451 0
Email 32451 0
[email protected]
Contact person for public queries
Name 15698 0
Dr Dr. Sylvie Lambert
Address 15698 0
Ingram School of Nursing
McGill University
Wilson Hall
3506 Sherbrooke St
Montreal, Quebec H3A2A7
Country 15698 0
Canada
Phone 15698 0
+1 514 797 3762
Fax 15698 0
+1 514 398 8455
Email 15698 0
[email protected]
Contact person for scientific queries
Name 6626 0
Dr Dr. Sylvie Lambert
Address 6626 0
Ingram School of Nursing
McGill University
Wilson Hall
3506 Sherbrooke St
Montreal, Quebec H3A2A7
Country 6626 0
Canada
Phone 6626 0
+1 514 797 3762
Fax 6626 0
+1 514 398 8455
Email 6626 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.