Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000003370
Ethics application status
Approved
Date submitted
15/12/2016
Date registered
3/01/2017
Date last updated
4/04/2024
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How does the diagnosis of a bowel condition affect quality of life and how do people manage their health?
Scientific title
Assessing quality of life and attitudes toward health self-management in people aged 40 or older who have had a recent diagnosis of a bowel condition with colonoscopy.
Secondary ID [1] 290773 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal diseases 301370 0
Condition category
Condition code
Cancer 301123 301123 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 301124 301124 0 0
Health service research
Cancer 330127 330127 0 0
Oesophageal (gullet)
Cancer 330128 330128 0 0
Stomach

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People aged 40 or older and who have had a recent diagnosis of a bowel condition at colonoscopy will be contacted about this study. This will include people with a main diagnosis of a small adenoma, a significant adenoma, bowel cancer of stage I, II, III or IV, or those with non-neoplastic findings such as diverticular disease or haemorrhoids. People aged 40 or older and who have had a recent diagnosis of a upper gastrointestinal condition at endoscopy will also be contacted about this study. This will include people with gastric or oesophageal cancer of stage I, II, III or IV, or those with non-neoplastic findings such as inflammation, polyps, Barrett’s oesophagus, varices, ulcers, coeliac disease or normal endoscopy. Within two weeks after colonoscopy or endoscopy, people will be sent a letter inviting them to take part in a questionnaire at this time point and again 12 months later. The questionnaire contains four sections. Section A mainly includes questions about health conditions and any treatment that the person may have received in the past 12 months. Section B contains questions about health-related quality of life and wellbeing. Section C contains questions on attitudes towards managing health. Section D includes questions about the person's background. If the questionnaire is not returned within two weeks then research staff will make telephone contact with the invitees to follow-up and confirm their willingness or otherwise to participate in the study.

Another sub-group of participants will now be included in this study, to capture more information about the quality of life (QOL) from individuals who have completed treatment for colorectal adenocarcinoma, gastric adenocarcinoma or oesophageal adenocarcinoma (stages I, II, III, IV).
A single questionnaire will be offered to these individuals who are within 3 years post-surgery/neoadjuvant therapy.
Intervention code [1] 296683 0
Not applicable
Intervention code [2] 296684 0
Not applicable
Comparator / control treatment
The control group will be people aged 40 or older who have had a recent colonoscopy and who have had no bowel pathology found (ie. a finding of a normal bowel). The control group will receive the same questionnaire within two weeks after colonoscopy and again after 12 months. They will also be contacted by research staff if the questionnaire has not been returned within two weeks.
Control group
Active

Outcomes
Primary outcome [1] 300533 0
The primary outcome will be the quality of life in people who have been diagnosed with a bowel condition. This will be assessed by questionnaire using existing surveys- a generic preference-based health related quality of life instrument (the EQ-5D-5L), a cancer-specific quality of life instrument (the EORTC QLQ-C30) and a widely used subjective wellbeing measure (the Satisfaction with Life Scale).
Timepoint [1] 300533 0
This will be assessed via questionnaire within two weeks and 12 months after colonoscopy.
Secondary outcome [1] 330247 0
A secondary outcome will be the health activation scores in people who have been diagnosed with a bowel condition. This will be assessed by questionnaire using an existing survey, the commonly used Consumer Health Activation Index (CHAI) survey.
Timepoint [1] 330247 0
This will be assessed via questionnaire within two weeks and at 12 months after colonoscopy.
Secondary outcome [2] 330248 0
Another outcome for this study will be to determine the relationship of quality of life with health activation in people who have been diagnosed with a bowel condition. This will be assessed by determining quality of life using existing surveys including a generic preference-based health related quality of life instrument (the EQ-5D-5L), a cancer-specific quality of life instrument (the EORTC QLQ-C30), and the Satisfaction with Life Scale survey, and compared to the findings from the Consumer Health Activation Index (CHAI) survey.
Timepoint [2] 330248 0
This will be assessed via questionnaire within two weeks and at 12 months after colonoscopy.
Secondary outcome [3] 376587 0
Another outcome to this study will be to compare variables and experiences of those who have completed treatment for CRC. A once-only, QOL existing survey will offered to eligible individuals. This will include the generic preference-based health related quality of life instrument (the EQ-5D-5L), the cancer-specific quality of life instrument (the EORTC QLQ-C30), and the Satisfaction with Life Scale survey, which will be compared to the findings from the Consumer Health Activation Index (CHAI) survey.
Timepoint [3] 376587 0
Within 3 years of treatment, surgery or neoadjuvant therapy, for colorectal adenocarcinoma.

Eligibility
Key inclusion criteria
-Recent colonoscopy (within two weeks) where one of the following new diagnoses are made: colorectal cancer, advanced adenoma, non-advanced adenoma, no neoplasia but other pathology (such as diverticular disease, haemorrhoids), normal colonoscopy
-Aged 40 years or older
-Be able to read and write in English
-History of colorectal cancer treatment within the last 3 years
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Currently has another type of cancer
-Has a pre-existing and ongoing bowel condition that requires medication or is the indication for the colonoscopy, eg. inflammatory bowel disease

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/01/2017
Actual
27/04/2017
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
8/11/2025
Actual
Sample size
Target
975
Accrual to date
349
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7159 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 9623 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 14917 0
5042 - Bedford Park
Recruitment postcode(s) [2] 18380 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 295193 0
Government body
Name [1] 295193 0
National Health and Medical Research Council
Country [1] 295193 0
Australia
Primary sponsor type
Individual
Name
Erin Symonds
Address
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Bedford Park
South Australia 5041
Country
Australia
Secondary sponsor category [1] 294023 0
None
Name [1] 294023 0
Address [1] 294023 0
Country [1] 294023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296545 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 296545 0
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 296545 0
Australia
Date submitted for ethics approval [1] 296545 0
10/08/2016
Approval date [1] 296545 0
17/11/2016
Ethics approval number [1] 296545 0
443.16

Summary
Brief summary
The primary purpose of this study is to determine how the diagnosis of a bowel condition at colonoscopy/upper gastrointestinal condition at endoscopy, impacts quality of life, and whether this changes between diagnosis and one year later? We would also like to investigate the differences in the quality of life for those who have experienced surgery and/or neoadjuvant therapy, for colorectal, oesophageal or gastric cancer, within 3 years of treatment.

Who is it for? Participants for this study will be people who have had a colonoscopy within the last two weeks, who have a diagnosis of one of the following at colonoscopy: (1) bowel cancer (stages I, II, III or IV), (2) advanced adenoma, (3) small non-advanced adenoma, (4) non-neoplastic findings (such as diverticular disease or haemorrhoids) or (5) no pathology detected (normal colon). People who have had an endoscopy within the last two weeks, who have a diagnosis for one of the following: (1) inflammation, (2) polyps, (3) oesophageal varices, (4) ulcers, (5) coeliac disease (6) Barrett’s oesophagus, (7) gastric cancer (stages I, II, III, IV), (8) oesophageal cancer (stages I, II, III, IV), or (9) no pathology detected, are also eligible. Also, for those who have had prior treatment for colorectal, oesophageal or gastric adenocarcinoma (stages I, II, III or IV) within the last 3 years.

Study details: All study invitees will be sent via mail a study invitation letter and a questionnaire within two weeks after their colonoscopy appointment. The questionnaire contains questions about health conditions, health-related quality of life and well-being, attitudes toward managing health and other basic demographic questions (including age, education level and country of birth). A two week period will be allowed following the mail out of letters for return of completed questionnaires. If the questionnaire has not been returned during this time, then research staff will make telephone contact with the study invitees to follow-up and confirm their willingness or otherwise to participate in the study. Those who complete the questionnaire will be invited to complete the same questionnaire 12 months later. Individuals who have had prior treatment for colorectal, oesophageal or gastric cancer, within 3 years, will be sent the same information, an invitation letter, participant information sheet and consent and a once-only questionnaire. Follow-up telephone contact will also be initiated, should there be no response after two weeks. The invitees are given the option to withdraw from the offer of participation by telephone or withdrawal form, at any time.

It is hoped that the findings of this trial will provide health related quality of life data for different bowel and upper gastrointestinal conditions and experiences in the Australian population. This can then be used in health economic modelling to assess the cost effectiveness of bowel cancer screening.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71230 0
A/Prof Erin Symonds
Address 71230 0
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country 71230 0
Australia
Phone 71230 0
+61 8 84042813
Fax 71230 0
Email 71230 0
Erin.Symonds@sa.gov.au
Contact person for public queries
Name 71231 0
A/Prof Erin Symonds
Address 71231 0
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country 71231 0
Australia
Phone 71231 0
+61 8 84042813
Fax 71231 0
Email 71231 0
Erin.Symonds@sa.gov.au
Contact person for scientific queries
Name 71232 0
A/Prof Erin Symonds
Address 71232 0
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country 71232 0
Australia
Phone 71232 0
+61 8 84042813
Fax 71232 0
Email 71232 0
Erin.Symonds@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data / or any raw data will be shared without appropriate future consent and/or ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5553Informed consent form  erin.symonds@sa.gov.au 372043-(Uploaded-21-10-2019-16-00-35)-Study-related document.docx
5554Informed consent form  erin.symonds@sa.gov.au 372043-(Uploaded-21-10-2019-16-02-01)-Study-related document.docx



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.