Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000924954
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
29/08/2011
Date last updated
19/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a web-based tool for estimating and explaining prognosis to people with advanced cancer
Scientific title
Evaluation of a web-based tool for estimating and explaining prognosis to people with advanced cancer
Secondary ID [1] 262942 0
nil
Universal Trial Number (UTN)
U1111-1124-0718
Trial acronym
iTool
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced cancer 270668 0
Condition category
Condition code
Cancer 270840 270840 0 0
Any cancer
Public Health 270845 270845 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a web-based tool (iTool) designed to assist oncologists calculate and explain three individualized scenarios for survival - best case, worst case and most likely- to patients with incurable cancer who want this sort of information.

The iTool can be accessed on any computer with an internet connection but for this study it will be loaded onto iPads that oncologists will use in the clinic with patients. When a participating oncologist has a patient requesting survival information, the oncologist is required to use their knowledge and experience to estimate the “median” survival for a group of patients with a similar cancer, treatment status and prognostic factors to the one in question. The oncologist enters the estimate in months into the iTool and the iTool calculates three scenarios for survival using simple formulae discovered in previous work These scenarios will be displayed on the iPad screen with an image to assist the oncologist communicate the information to the patient. This screenshot can be printed after the consultation with copies available for the patient and/or family members to take home, a copy placed in the patient’s notes and a copy sent to other health professionals involved in the patient’s care.
The iTool will be used by each participating oncologist as often as required during the 6 month study period. We estimate each oncologist will use the tool once per week.
Intervention code [1] 269286 0
Other interventions
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279524 0
The percentage of patients who agree that the prognostic information provided by the web-based tool is helpful. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [1] 279524 0
2 weeks after the intervention
Secondary outcome [1] 287815 0
The percentage of patients who agree that the prognostic information makes sense. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [1] 287815 0
2 weeks after the intervention
Secondary outcome [2] 287816 0
The percentage of patients who agree that the prognostic information helps them make plans. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [2] 287816 0
2 weeks after the intervention
Secondary outcome [3] 287817 0
The percentage of patients who agree that the prognostic information gives them hope. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [3] 287817 0
2 weeks after the intervention
Secondary outcome [4] 287818 0
The percentage of patients who agree that the prognostic information reassures them. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [4] 287818 0
2 weeks after the intervention
Secondary outcome [5] 287819 0
The percentage of patients who agree that the prognostic information upsets them. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [5] 287819 0
2 weeks after the intervention
Secondary outcome [6] 287820 0
The percentage of patients who agree that the prognostic information improves their understanding. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [6] 287820 0
2 weeks after the intervention
Secondary outcome [7] 287821 0
The percentage of patients who agree that the prognostic information increases their anxiety. Assessed via a written study specific questionnaire completed by patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of patients that agree and strongly agree with the statement by the total number of patients answering for that statement multiplied by 100.
Timepoint [7] 287821 0
2 weeks after the intervention
Secondary outcome [8] 287822 0
The percentage of occasions when the oncologist used the web-based tool and agreed that the Tool was helpful. Assessed via a web-based study specific questionnaire completed by oncologists at the end of each consultation where the tool is used. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of oncologists that agree and strongly agree with the statement by the total number of oncologists answering for that statement multiplied by 100.
Timepoint [8] 287822 0
within 24 hours of the intervention
Secondary outcome [9] 287823 0
The percentage of occasions when the oncologist used the web-based tool and agreed that the tool was easy to use. Assessed via a web-based study specific questionnaire completed by oncologists at the end of each consultation where the tool is used. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of oncologists that agree and strongly agree with the statement by the total number of oncologists answering for that statement multiplied by 100.
Timepoint [9] 287823 0
within 24 hours of the intervention
Secondary outcome [10] 287824 0
The percentage of occasions when the oncologist used the web-based tool and agreed that the tool was stressful. Assessed via a web-based study specific questionnaire completed by oncologists at the end of each consultation where the tool is used. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of oncologists that agree and strongly agree with the statement by the total number of oncologists answering for that statement multiplied by 100.
Timepoint [10] 287824 0
within 24 hours of the intervention
Secondary outcome [11] 287825 0
The percentage of occasions when the oncologist used the web-based tool and agreed that the tool was time saving. Assessed via a web-based study specific questionnaire completed by oncologists at the end of each consultation where the tool is used. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of oncologists that agree and strongly agree with the statement by the total number of oncologists answering for that statement multiplied by 100.
Timepoint [11] 287825 0
within 24 hours of the intervention
Secondary outcome [12] 287826 0
The percentage of other health professionals who agree that receiving the survival information is helpful. Assessed via a written study specific questionnaire completed by other health professionals within 4 weeks of receiving the prognostic information about one of their patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of health professionals that agree and strongly agree with the statement by the total number of health professionals answering for that statement multiplied by 100.
Timepoint [12] 287826 0
4 weeks after the intervention
Secondary outcome [13] 287827 0
The percentage of other health professionals who agree that receiving the survival information makes sense. Assessed via a written study specific questionnaire completed by other health professionals within 4 weeks of receiving the prognostic information about one of their patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of health professionals that agree and strongly agree with the statement by the total number of health professionals answering for that statement multiplied by 100.
Timepoint [13] 287827 0
4 weeks after the intervention
Secondary outcome [14] 287828 0
The percentage of other health professionals who agree that receiving the survival information improves their understanding. Assessed via a written study specific questionnaire completed by other health professionals within 4 weeks of receiving the prognostic information about one of their patients. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of health professionals that agree and strongly agree with the statement by the total number of health professionals answering for that statement multiplied by 100.
Timepoint [14] 287828 0
4 weeks after the intervention
Secondary outcome [15] 287829 0
The percentage of family members who agree that the survival information is helpful. Assessed via a written study specific questionnaire completed by family members who were present during the consultation with the medical oncologist when prognosis was expleained using the web-based tool. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of family members that agree and strongly agree with the statement by the total number of family members answering for that statement multiplied by 100.
Timepoint [15] 287829 0
2 weeks after the intervention
Secondary outcome [16] 287830 0
The percentage of family members who agree that the survival information makes sense. Assessed via a written study specific questionnaire completed by family members who were present during the consultation with the medical oncologist when prognosis was expleained using the web-based tool. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of family members that agree and strongly agree with the statement by the total number of family members answering for that statement multiplied by 100.
Timepoint [16] 287830 0
2 weeks after the intervention
Secondary outcome [17] 287831 0
The percentage of family members who agree that the survival information gives them hope. Assessed via a written study specific questionnaire completed by family members who were present during the consultation with the medical oncologist when prognosis was expleained using the web-based tool. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of family members that agree and strongly agree with the statement by the total number of family members answering for that statement multiplied by 100.
Timepoint [17] 287831 0
2 weeks after the intervention
Secondary outcome [18] 287832 0
The percentage of family members who agree that the survival information reassures them. Assessed via a written study specific questionnaire completed by family members who were present during the consultation with the medical oncologist when prognosis was expleained using the web-based tool. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of family members that agree and strongly agree with the statement by the total number of family members answering for that statement multiplied by 100.
Timepoint [18] 287832 0
2 weeks after the intervention
Secondary outcome [19] 287833 0
The percentage of family members who agree that the survival information upsets them. Assessed via a written study specific questionnaire completed by family members who were present during the consultation with the medical oncologist when prognosis was expleained using the web-based tool. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of family members that agree and strongly agree with the statement by the total number of family members answering for that statement multiplied by 100.
Timepoint [19] 287833 0
2 weeks after the intervention
Secondary outcome [20] 287834 0
The percentage of family members who agree that the survival information improves their understanding. Assessed via a written study specific questionnaire completed by family members who were present during the consultation with the medical oncologist when prognosis was expleained using the web-based tool. The questionnaire contains a series of study-specific statements and 5-point Likert scales to elicit attitudes to each statement (strongly agree, agree, unsure, disagree and strongly disagree). Percentages calculated by dividing the number of family members that agree and strongly agree with the statement by the total number of family members answering for that statement multiplied by 100.
Timepoint [20] 287834 0
2 weeks after the intervention

Eligibility
Key inclusion criteria
1. Patients
- attending outpatient clinic of participating medical oncologist
- diagnosed with advanced cancer
- want information on their prognosis
- able and willing to complete the study questionnaires
2. Australian medical oncologists caring for patients with advanced cancer
3. Other health professionals involved in the care of the patient
4. Family members and carers of the patient present in the room when the oncologist explains prognosis to the patient

All participants must be able to speak and write in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
people unable to speak and write English
patients with early (curable) cancer
patients who do not want information on their prognosis
people unable to provide informed consent
patients currently admitted to the hospital (inpatients)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participating medical oncologists will be provided with an iPad loaded with the prognostic tool and encouraged to use it to calculate and explain individualized scenarios for survival for patients wanting to discuss survival time. Summaries of the survival information will be printed and given to patients, family members and other health professionals involved in the care of each patient.

Oncologists will complete a brief questionnaire after using the tool with a patient to evaluate how helpful they found the tool.

Following the discussion of prognosis the oncologist will ask the patient and any family members present to participate in an evaluation study of the web-based prognostic tool and the prognostic information it provides. Patients wanting to participate must provide written informed consent. They are then given a study-specific questionnaire to complete in the next 2 weeks. The questionnaire asks about how helpful the information was.

Family members wanting to participate are provided with a questionnaire to complete and return within 2 weeks. Return of a completed questionnaire will be indicative of consent.

Other health professionals involved in the patient's care will be posted a copy of the survival information as well as the study information and a questionnaire to complete and return by post within 4 weeks. The questionnaire evaluates how helpful they found the prognostic information.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
4 groups of participants will all evaluate the web-based prognositc tool by completing different study specicfic questionnaires.
1. Medical Oncologists
2. Patients with advanced cancer
3. Family members and carers of people with advacned cancer
4. Other health professionals caring for patients with advanced cancer
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
16/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4406 0
2050
Recruitment postcode(s) [2] 4407 0
2560
Recruitment postcode(s) [3] 4408 0
2830
Recruitment postcode(s) [4] 4409 0
2139
Recruitment postcode(s) [5] 4410 0
2145

Funding & Sponsors
Funding source category [1] 269748 0
Charities/Societies/Foundations
Name [1] 269748 0
Conquer Cancer Foundation of the American Society of Clinical Oncology
Country [1] 269748 0
United States of America
Funding source category [2] 287474 0
Government body
Name [2] 287474 0
Cancer Australia
Country [2] 287474 0
Australia
Primary sponsor type
University
Name
NHMRC Clinical Trials Centre, University of Sydney
Address
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 268788 0
None
Name [1] 268788 0
Address [1] 268788 0
Country [1] 268788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271713 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 271713 0
Ethics committee country [1] 271713 0
Australia
Date submitted for ethics approval [1] 271713 0
12/09/2011
Approval date [1] 271713 0
05/12/2011
Ethics approval number [1] 271713 0
2011C/09/173

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33084 0
Dr Belinda Kiely
Address 33084 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 33084 0
Australia
Phone 33084 0
+61 2 9562 5000
Fax 33084 0
+61 2 9565 1863
Email 33084 0
[email protected]
Contact person for public queries
Name 16331 0
iTool Coordinator
Address 16331 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 16331 0
Australia
Phone 16331 0
+61 2 9562 5000
Fax 16331 0
+61 2 9562 5094
Email 16331 0
[email protected]
Contact person for scientific queries
Name 7259 0
Belinda Kiely
Address 7259 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 7259 0
Australia
Phone 7259 0
+61 2 9562 5000
Fax 7259 0
+61 2 9565 1863
Email 7259 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.