Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000720819
Ethics application status
Approved
Date submitted
20/06/2012
Date registered
5/07/2012
Date last updated
9/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Haematological Cancer Web Program Randomised Controlled Trial (RCT)
Scientific title
Improving psychosocial outcomes for haematological cancer patients using a web-based program: A Randomised Controlled Trial (RCT)
Secondary ID [1] 280706 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myeloid leukaemia 286744 0
Acute lymphoblastic leukaemia 286745 0
Burkitt lymphoma 286746 0
Lymphoblastic lymphoma (B or T cell) 286747 0
Diffuse large B cell lymphoma 291122 0
Condition category
Condition code
Public Health 287046 287046 0 0
Health service research
Cancer 287159 287159 0 0
Leukaemia - Acute leukaemia
Cancer 287160 287160 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies. Patients will be able to access the website at their own discretion using iPads provided by the research team. The intervention will also include access to a telephone helpline staffed by an experienced cancer nurse. Participants will be able to call the helpline during work hours and may leave a voicemail message after hours. The intervention will be available to experimental group participants for a period of 12 weeks.
Intervention code [1] 285125 0
Behaviour
Comparator / control treatment
Patients and significant others allocated to the usual care group will receive care normally provided by their health care team. This may vary across hospitals, however will generally involve discussion of treatment options between the clinician and patient and the provision of written information booklets.
Control group
Active

Outcomes
Primary outcome [1] 287381 0
Primary Outcome 1: Anxiety and Depression measured by the Hospital Anxiety and Depression Scale (patients) and the Distress, Anxiety and Depression Scale (support persons)
Timepoint [1] 287381 0
Timepoint: 2, 4, 8 and 12 weeks post-recruitment into the study
Primary outcome [2] 287382 0
Primary Outcome 2: Unmet Needs measured by the Supportive Care Needs Survey Short Form-38 (patients) and the Support Persons Unmet Needs Scale (support persons)
Timepoint [2] 287382 0
Timepoint: 2, 4, 8 and 12 weeks post-recruitment into the study
Secondary outcome [1] 298040 0
Secondary Outcome 1: Information Experiences measured by a questionnaire specifically developed by the research team
Timepoint [1] 298040 0
Timepoint: 2, 4, 8 and 12 weeks post-recruitment into the study for patients and 4 weeks only for support persons
Secondary outcome [2] 298041 0
Secondary Outcome 2: Acceptability of the Web Program measured by a questionnaire specifically developed by the research team
Timepoint [2] 298041 0
Timepoint: 4 weeks post-recruitment into the study (Experimental Group participants only)

Eligibility
Key inclusion criteria
Patient sample: Eligible patients will be: aged 18 years or older; English speaking; and newly diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt lymphoma, Lymphoblastic lymphoma (B or T cell), Diffuse large B cell lymphoma, potentially making a decision regarding treatment; have a life expectancy of 2 months or more as judged by their clinician; and able to provide informed consent. Support person sample: Eligible support persons will be aged 18 or older, able to provide informed consent, and considered by the patient to be an important source of support in relation to the demands of their cancer diagnosis and treatment. It is very likely that most support persons will be healthy participants however the physical health status of support persons will not be directly assessed and is not the focus of the present research.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking participants, participants under the age of 18, and people with an intellectual or mental impairment have been specifically excluded from the research. Participants under the age of 18 have been excluded as they are unable to give informed consent. While it would be of interest to include non-English speaking participants, they have been excluded due to anticipated difficulties in responding to the written survey and using the website intervention which will be produced in English only. Given informed consent is required as well as completing surveys and accessing web-based information (for the intervention group), people with an intellectual or mental impairment have also been excluded.

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 will be carried out by clinicians during their first consultation with newly diagnosed patients. Clinicians will be asked to inform patients about the study, provide an information statement and seek informed written consent.

For consenting patients, their participant ID, contact details and date of enrolment into the study will be recorded. Data about non-consenters will also be recorded (Record age, gender, type of cancer and time since diagnosis).

Randomisation to experimental groups: Patients and SPs who agree to participate will be block randomised by week by the clinician during their first consultation. To assist with this process a calendar outlining which weeks correspond to each condition will be provided to the clinician. Allocation is not concealed.

For patients allocated to the experimental condition, clinicians will complete a brief online form to create a user ID for the patient and support person to access the web program, and provide the patient with printed information about how to access the web program. Consenting patients will also be given an information sheet and consent form to give to their SP.

Support persons will be formally enrolled into the study and their information recorded when their completed consent form has been received by the researchers via post (a self-addressed reply paid envelope is provided to support persons along with the study information). Consenting support persons are allocated to the same study arm as the patient they are supporting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be block randomised, with week as the unit of analysis. Randomisation will occur as a consequence of a computer-generated random list.
Masking / blinding
Open (masking not 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
23/07/2012
Actual
2/11/2012
Date of last participant enrolment
Anticipated
Actual
31/10/2014
Date of last data collection
Anticipated
Actual
2/02/2015
Sample size
Target
680
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 5407 0
2031
Recruitment postcode(s) [2] 5408 0
2050
Recruitment postcode(s) [3] 5409 0
2217
Recruitment postcode(s) [4] 5410 0
2298
Recruitment postcode(s) [5] 5411 0
2250
Recruitment postcode(s) [6] 5412 0
2010
Recruitment postcode(s) [7] 7758 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 285476 0
Government body
Name [1] 285476 0
Cancer Institute New South Wales
Country [1] 285476 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 284328 0
Hospital
Name [1] 284328 0
Royal North Shore Hospital
Address [1] 284328 0
Royal North Shore Hospital
Reserve Road
ST LEONARDS NSW 2065
Country [1] 284328 0
Australia
Other collaborator category [1] 276870 0
Charities/Societies/Foundations
Name [1] 276870 0
Leukaemia Foundation
Address [1] 276870 0
Leukaemia Foundation
230 Lutwyche Rd
Windsor QLD 4030
Country [1] 276870 0
Australia
Other collaborator category [2] 276871 0
Charities/Societies/Foundations
Name [2] 276871 0
Cancer Council NSW
Address [2] 276871 0
Cancer Council NSW
153 Dowling Street
Woolloomooloo NSW 2011
Country [2] 276871 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287492 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 287492 0
Level 9, 8 Central Avenue
Australian Technology Park
Eveleigh, NSW 2015

PO Box 41
Alexandria, NSW 1435
Ethics committee country [1] 287492 0
Australia
Date submitted for ethics approval [1] 287492 0
Approval date [1] 287492 0
05/12/2011
Ethics approval number [1] 287492 0
2011C/09/172
Ethics committee name [2] 287493 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 287493 0
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 287493 0
Australia
Date submitted for ethics approval [2] 287493 0
Approval date [2] 287493 0
03/04/2012
Ethics approval number [2] 287493 0
H-2012-0011
Ethics committee name [3] 290537 0
Hunter New England Human Research Ethics Committee
Ethics committee address [3] 290537 0
Hunter New England Human Research Ethics Committee
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [3] 290537 0
Australia
Date submitted for ethics approval [3] 290537 0
Approval date [3] 290537 0
23/09/2013
Ethics approval number [3] 290537 0
HREC/13/HNE/338

Summary
Brief summary
Key challenges faced by patients with cancer and their families include coping with a potentially life threatening disease, making decisions about cancer treatment, and managing the side effects of cancer and its treatment. In particular, those diagnosed with haematological cancers may be at high risk for psychosocial distress. Communicating treatment options, the likely impact of treatments, preparing patients for cancer treatments and providing them with information about how to manage side effects of treatment are likely to be key to helping patients and their families cope with a diagnosis of cancer. The purpose of this study is to examine whether an integrated approach (including access to a web-based program and nurse-delivered telephone support) to helping haematological patients with key psychosocial challenges is effective in reducing depression, anxiety, and unmet information needs among patients and their support persons. Participants will be assigned to either a 12-week period of accessing a web-based program designed to provide effective communication, decisional support and adjustment via research staff-provided iPads, or your usual standard of care normally provided by your care team. Who is it for? 10 tertiary referral hospitals that treat at least 15 patients per year will be invited to participate. In order to be eligible for this trial, you will need to be aged 18 years or older; English speaking; newly diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt lymphoma, Lymphoblastic lymphoma (B or T cell), Diffuse large b cell lymphoma, potentially making a decision regarding treatment; have a life expectancy of 2 months or more as judged by their clinician; and be able to provide informed consent. This study will also include participation by a sample of support persons, where each patient will be asked to nominate a designated support person. Eligible support persons will be aged 18 or older, able to provide informed consent, and considered by the patient to be an important source of support in relation to the demands of their cancer diagnosis and treatment. Trial Details Consenting eligible patients will be consented into the study by the clinician in their first consultation. Each patient will be given an information statement and consent form to pass onto their nominated support person. Patients and support persons will then be block randomised by week to either the experimental or usual care group. Experimental group: Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies. Patients will be able to access the website through iPads provided by the research team. The intervention will also include access to a telephone helpline staffed by an experienced cancer nurse. Usual care: Patients and significant others allocated to the usual care group will receive care normally provided by their care team. Follow-up: Patient and support person follow-up surveys will be completed at approximately 2, 4, 8 and 12 weeks post-recruitment into the study.
Trial website
Trial related presentations / publications
Smits R, Bryant J, Sanson-Fisher R, Tzelepis F, Henskens F, Paul C, Stevenson W. The potential of tailored and integrated web-based tools for improving psychosocial outcomes of cancer patients: The DoTTI development framework. J Med Internet Res. 2014, Mar 16(3): e7

Bryant, J., Sanson-Fisher, R., Stevenson, W., Smits, R., Henskens, F., Wei, A., Tzelepis, F., D’Este, C., Paul, C., & Carey, M. Protocol of a multi-centre randomised controlled trial of a web-based information intervention with nurse-delivered telephone support for haematological cancer patients and their support persons. BMC Cancer. 2015, 15(1): 295.

Bryant, J., Mansfield, E., Hall, A., Waller, A., Boyes, A., Jayakody, A., Dodd, N., Sanson-Fisher, R. The psychosocial outcomes of individuals with hematological cancers: Are we doing enough high quality research, and what is it telling us? Critical Reviews in Oncology/Hematology. 2016, May 101: 21-31.

Paul, D., Henskens, F. A., Bryant, J., Smits, R., Sanson-Fisher, R.W., and Stevenson, W. "The Haematology Treatment Aid: Providing Personalized Information to Patients and Carers", The 6th International Conference on e-Health, Lisbon, Portugal, IADIS, pp. 372-376, July 2014.

Bryant J, Sanson-Fisher R, Stevenson W, Henskens F, R S. Build it, but will They Come? Development and patient use of an Online Information Tool Designed to Reduce Psychosocial Distress. Abstracts of the IPOS 15th World Congress of Psycho-Oncology. 4–8 November 2013, Rotterdam, The Netherlands: Psycho-Oncology, 2013, 22(S3):124-362.
Public notes
A summary of the results is available to participants. Please contact the research team to obtain a copy of the results. A link to the scientific publication reporting the results of the study will be provided when available.

Contacts
Principal investigator
Name 34341 0
Prof Rob Sanson-Fisher
Address 34341 0
Health Behaviour Research Group
W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 34341 0
Australia
Phone 34341 0
+61 2 4042 0713
Fax 34341 0
+61 2 4042 0044
Email 34341 0
[email protected]
Contact person for public queries
Name 17588 0
Laureate Professor Rob Sanson-Fisher
Address 17588 0
Health Behaviour Research Group
W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 17588 0
Australia
Phone 17588 0
+61 2 4042 0713
Fax 17588 0
+61 2 4042 0044
Email 17588 0
[email protected]
Contact person for scientific queries
Name 8516 0
Laureate Professor Rob Sanson-Fisher
Address 8516 0
Health Behaviour Research Group
W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 8516 0
Australia
Phone 8516 0
+61 2 40420713
Fax 8516 0
+61 2 40420044
Email 8516 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

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