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
ACTRN12607000061437
Ethics application status
Approved
Date submitted
9/11/2000
Date registered
9/11/2000
Date last updated
22/04/2022
Date data sharing statement initially provided
22/04/2022
Date results information initially provided
22/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a coping training intervention (CanCOPE) that includes the support person improve psychological adjustment and immune function in women with breast cancer?
Scientific title
Impact of a psychological intervention (CanCOPE) upon psychological and immune function, and disease course in women with breast cancer
Secondary ID [1] 21 0
National Clinical Trials Registry: NCTR341
Universal Trial Number (UTN)
Trial acronym
NHMRC 9937170
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early stage breast cancer 21 0
Condition category
Condition code
Cancer 21 21 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CanCOPE is a self directed program and consists of a videotape and guidebook, with no face-to-face contact with a professional during the program. Women and their support persons assigned to CanCOPE receive via the video and guidebook that provides a five-step training program in cancer specific coping and stress management skills, supportive communication, and problem solving. CanCOPE uses a combination of videotaped and written educational tools to teach the woman and her support person coping and mutual support skills. Their progress is reviewed during regular telephone sessions with a psychologist. Dyads receive a total of 9 1hr phone calls over the 12 month period following diagnosis.
Intervention code [1] 1472 0
Rehabilitation
Comparator / control treatment
Standard care is as provided at the clinical sites, and we assess the number and nature of contact patients have with medical staff, or community organisations.
Control group
Active

Outcomes
Primary outcome [1] 38 0
Positve and Negative affect, (PANAS:Watson etal, 1988)
Timepoint [1] 38 0
Pre interventiion, post intervention, 6 month follow-up.
Primary outcome [2] 39 0
Meaning in life, (Constucted meaning Scale, Fife, 1995)
Timepoint [2] 39 0
Pre interventiion, post intervention, 6 month follow-up.
Primary outcome [3] 40 0
Psycholoigcal adjustment to illness (PAIS, Derogatis 1983)
Timepoint [3] 40 0
Pre interventiion, post intervention, 6 month follow-up.
Primary outcome [4] 41 0
Trauma Symptoms (RIES, Horowitz et al, 1979)
Timepoint [4] 41 0
Pre interventiion, post intervention, 6 month follow-up.
Primary outcome [5] 42 0
Body image (SIS Scott at al, 20040)
Timepoint [5] 42 0
Pre interventiion, post intervention, 6 month follow-up.
Secondary outcome [1] 62 0
Immune function
Timepoint [1] 62 0
Pre and post intervention, 6 month follow-up.
Secondary outcome [2] 63 0
Physical symptoms (rotterdam Symptom checklist, De Haes et al, 1990); Physical rehabilitation (SF-36 Ware, 1993) health behavioiurs (DAC, Scott et al 2004).
Timepoint [2] 63 0
Pre and post intervention, 6 month follow-up.

Eligibility
Key inclusion criteria
Participants are 80 women diagnosed with early stage breast cancer and their nominated support person. They are recruited from oncology clinics situated in Brisbane. All patient-support person dyads are recruited following diagnosis, in the week prior to commencement of the women's cancer treatments. Inclusion Criteria (a) woman about to commence cancer treatment for a primary (localized or regional) breast cancer and has no history of other cancers. (b) no known history of neurological or psychiatric illness in either person, (c) both individuals able to read and speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) metastatic disease (b0 either individual can not read or write english (c) either individual has a history of severe psychological disorder.

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)
sealed opaque envelopes with randomisation genertaed by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/1999
Actual
15/06/1999
Date of last participant enrolment
Anticipated
Actual
3/01/2000
Date of last data collection
Anticipated
Actual
29/05/2000
Sample size
Target
80
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 28 0
Government body
Name [1] 28 0
National Health and Medical Research Council
Country [1] 28 0
Australia
Funding source category [2] 29 0
Charities/Societies/Foundations
Name [2] 29 0
Queensland Cancer Fund
Country [2] 29 0
Primary sponsor type
Individual
Name
Dr Jenn Scott
Address
Country
Secondary sponsor category [1] 25 0
Individual
Name [1] 25 0
Dr Mike Mc Guckin
Address [1] 25 0
Country [1] 25 0
Secondary sponsor category [2] 26 0
Individual
Name [2] 26 0
Dr Neil Wetzig
Address [2] 26 0
Country [2] 26 0
Secondary sponsor category [3] 27 0
Individual
Name [3] 27 0
Dr Chris Pyke
Address [3] 27 0
Country [3] 27 0
Secondary sponsor category [4] 28 0
Individual
Name [4] 28 0
Dr Bruce Ward
Address [4] 28 0
Country [4] 28 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272 0
Griffith University
Ethics committee address [1] 272 0
Ethics committee country [1] 272 0
Australia
Date submitted for ethics approval [1] 272 0
Approval date [1] 272 0
Ethics approval number [1] 272 0
HLS/17/98/hec
Ethics committee name [2] 273 0
Princess Alexandra Hospital
Ethics committee address [2] 273 0
Ethics committee country [2] 273 0
Australia
Date submitted for ethics approval [2] 273 0
Approval date [2] 273 0
20/06/1905
Ethics approval number [2] 273 0
186/98

Summary
Brief summary
A key goal in our research is to develop an empirically validated, cost effective psycho-educational coping program to improve pyshcoloigcal and physical adjustment for women with breast cancer and their nominate support persons.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 27406 0
Address 27406 0
Country 27406 0
Phone 27406 0
Fax 27406 0
Email 27406 0
Contact person for public queries
Name 10661 0
Dr Jenn Scott.
Address 10661 0
School of Psychology
University of Tasmania
Private Bag 30
Hobart TAS 7001
Country 10661 0
Australia
Phone 10661 0
61+ 7 6226 2245;
Fax 10661 0
61+ 7 6226 2883
Email 10661 0
[email protected]
Contact person for scientific queries
Name 1589 0
Dr Jenn Scott,
Address 1589 0
School of Psychology, Private bag 30, University of Tasmania, Hobart Tasmania 7001
Country 1589 0
Australia
Phone 1589 0
61+ 7 6226 2245
Fax 1589 0
61+ 7 6226 2883
Email 1589 0
[email protected]

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
No additional documents have been identified.