ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

gastrointestinal diseases

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Public Health

Health service research

Cancer

Oesophageal (gullet)

Cancer

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]

Not applicable

Intervention code [2]

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]

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]

This will be assessed via questionnaire within two weeks and 12 months after colonoscopy.

Secondary outcome [1]

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]

This will be assessed via questionnaire within two weeks and at 12 months after colonoscopy.

Secondary outcome [2]

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]

This will be assessed via questionnaire within two weeks and at 12 months after colonoscopy.

Secondary outcome [3]

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]

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

Noarlunga Health Service - Noarlunga Centre

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5168 - Noarlunga Centre

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1, 16 Marcus Clarke Street Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/08/2016

Approval date [1]

17/11/2016

Ethics approval number [1]

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

A/Prof Erin Symonds

Address

Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042

Country

Australia

Phone

+61 8 84042813

Fax

Erin.Symonds@sa.gov.au

Contact person for public queries

Name

Erin Symonds

Address

Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042

Country

Australia

Phone

+61 8 84042813

Fax

Erin.Symonds@sa.gov.au

Contact person for scientific queries

Name

Erin Symonds

Address

Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042

Country

Australia

Phone

+61 8 84042813

Fax

Erin.Symonds@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
5553	Informed consent form			erin.symonds@sa.gov.au		372043-(Uploaded-21-10-2019-16-00-35)-Study-related document.docx
5554	Informed 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.

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