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
ACTRN12613001309774
Ethics application status
Approved
Date submitted
14/10/2013
Date registered
25/11/2013
Date last updated
24/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating psychosocial and best supportive care needs of cancer patients from rural regions following active cancer therapy for improving quality of life and therapeutic management
Scientific title
In patients from rural regions who have undergone active cancer therapy, is the implementation of a survivorship care plan more effective than usual care in improving patient ability to self-manage psychosocial concerns?
Secondary ID [1] 283398 0
Nil
Universal Trial Number (UTN)
Trial acronym
RACTIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 290292 0
Tumour groups, stages and therapies required 290293 0
Psychosocial concerns for patients following active therapy 290300 0
Condition category
Condition code
Mental Health 290691 290691 0 0
Anxiety
Mental Health 290692 290692 0 0
Depression
Cancer 290693 290693 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions include involvement of allied health professionals to assess and assist the patient to manage patient concerns, where warranted. Allied health professionals may include counsellors (help participants with specific concerns e.g. establishing reciprocal understanding with family and friends regarding health issues being faced following therapy and the effects on lifestyle, physiotherapists to manage physiological concerns e.g. lymphodoema, Dieticians to aid with concerns around weight and/or dietry balance, Dermatologists where skin irritations persist or occur independently for other reasons, Exercise physiologist, if required to assist with appropriate exercise to aid in recovery, Social Worker to help participants manage lifestyle changes related to social networks, Psychologist if required for concerns such as depression. Outcomes of allied health professional assessments will enable appropriate intervention to be designed within a survivorship plan.
Determination of the requirement for intervention is based on results from assessment of changes in each of the symptoms (fatigue, fear of cancer returning, depression, coping with home/work duties, learning to live with ‘new normal’), from baseline information.

The timeframe is dependent on whether assessments from allied health professionals are warranted

Participants in this trial will be followed up until 30 months from recruitment
Intervention code [1] 288121 0
Early detection / Screening
Intervention code [2] 288122 0
Prevention
Intervention code [3] 288123 0
Lifestyle
Comparator / control treatment
Comparison is assessed with patients not receiving preventative interventions. That is, the initial data collecting phase will be the control group. The interventions required for specific concerns and the outcomes of those interventions will inform the primary and secondary outcomes with the aid of a survivorship care plan informed through questionnaire and interview.
Control group
Active

Outcomes
Primary outcome [1] 290705 0
Gain an understanding of what is being experienced by individuals following cancer treatment, to inform the creation of a survivorship care plan (SCP) dedicated to the psychosocial and best supportive care needs of the individual.
This outcome will be achieved using questionnaires and interviews.

The questionnaires used are PROMIS29 and the Distress Thermometer and will be analysed according to the scoring tools for each test with in-built result calculators.
The interviews will be coded and a Grounded Theory technique used to evaluate the needs of patients.
Timepoint [1] 290705 0
On completion of active therapy
Secondary outcome [1] 305651 0
To determine differences in needs between tumour groups and histological stages.
Statistical analysis tools used will be the t-test to compare the actual difference between the two means in relation to the variation in the data (different tumour groups). The p-test will be used to determine the probability of obtaining a test statistic at least as extreme as the one that was actually observed.
Timepoint [1] 305651 0
3 months and 6 months or 4+ years following active therapy

Eligibility
Key inclusion criteria
Adult patients older than, 18 years of age
Histological proven cancer (all tumour types)
Male or Female
Ability to comprehend questionnaire alone (or in juxtaposition with proxy, from commencement, in specific patients with acutely declining trajectory prediction)
Willingness to participate in a questionnaire-based study
Informed consent
Completed therapy during final two weeks of recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectancy predicted to be less than 6 months if not assisted by proxy/carer

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)
All patients completing therapy are offered participation during the final week of therapy. Purpose of trial discussed and possible benefits described
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized, controlled trial using simple randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Interventions determined by specific requirements of individual patients
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
2-sided t-test and ANOVA for quantitative analysis, Binomial Regression and ODDS Ratio using SSPS.
Grounded Theory, coding and analysis for qualitative analysis

The numbers of participants needed to achieve the study objectives was determined Acceptable level of significance (p=0.05), Power of the study (95% Confidence Level),

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2013
Actual
2/08/2013
Date of last participant enrolment
Anticipated
31/03/2018
Actual
31/03/2018
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
400
Accrual to date
Final
320
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1588 0
Riverina Cancer Care Centre - Wagga Wagga

Funding & Sponsors
Funding source category [1] 288118 0
Hospital
Name [1] 288118 0
In kind funding

The Riverina Cancer Care Centre
Country [1] 288118 0
Australia
Primary sponsor type
Hospital
Name
The Riverina Cancer Care Centre
Address
31 Meurant Avenue
Wagga Wagga
NSW 2650
Country
Australia
Secondary sponsor category [1] 286840 0
None
Name [1] 286840 0
Address [1] 286840 0
Country [1] 286840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290041 0
The Riverina Cancer Care Centre Ethics Committee
Ethics committee address [1] 290041 0
31 Meurant Avenue
Wagga Wagga
NSW 2650
Ethics committee country [1] 290041 0
Australia
Date submitted for ethics approval [1] 290041 0
22/07/2013
Approval date [1] 290041 0
01/08/2013
Ethics approval number [1] 290041 0
1.0

Summary
Brief summary
The study is attempting to gain an understanding of what is being experienced by individuals following cancer therapy in order to establish interventions where required to improve quality of life and therapeutic management. Who is it for? You may be eligible to join this study if you are aged over 18 years, diagnosed with any cancer and will complete cancer therapy during the final two weeks of this trial’s recruitment phase. The trial involves a set of three questionnaires at 3-monthly time intervals and an interview.
Where warranted, allied health professionals will assess and assist participants to manage their concerns after cancer therapy. Assessments will be conducted using questionnaires and interviews. The allied health professionals assessing the participants may include counsellors (to help participants with specific concerns such as establishing reciprocal understanding with family and friends regarding health issues being faced following therapy and the effects on lifestyle), physiotherapists (to help participants with managing physiological concerns such as lymphoedema), dieticians (to aid participants with concerns about weight and/or dietary balance), dermatologists (for concerns such as skin irritations), exercise physiologist (to assist with appropriate exercise to aid in recovery), social worker (to help participants manage lifestyle changes related to social networks), and psychologist (to aid with concerns such as depression). Outcomes of allied health professional assessments will enable appropriate intervention to be designed within a survivorship plan. The determination of the requirement for intervention will be based on results from assessment of changes in fatigue, fear of cancer returning, depression, coping with home/work duties, and learning to live with ‘new normal’ in participants in comparison to baseline information.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 43066 0
Mrs Mari Lashbrook
Address 43066 0
The Riverina Cancer Care Centre
31 Meurant Avenue,
Wagga Wagga
NSW 2650
Country 43066 0
Australia
Phone 43066 0
+61 2 69321000
Fax 43066 0
+61 2 69254848
Email 43066 0
[email protected]
Contact person for public queries
Name 43067 0
Mrs Mari Lashbrook
Address 43067 0
The Riverina Cancer Care Centre
31 Meurant Avenue,
Wagga Wagga
NSW 2650
Country 43067 0
Australia
Phone 43067 0
+61 2 69321000
Fax 43067 0
+61 2 69254848
Email 43067 0
[email protected]
Contact person for scientific queries
Name 43068 0
Mrs Mari Lashbrook
Address 43068 0
The Riverina Cancer Care Centre
31 Meurant Avenue,
Wagga Wagga
NSW 2650
Country 43068 0
Australia
Phone 43068 0
+61 2 69321000
Fax 43068 0
+61 2 69254848
Email 43068 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.