Condition category
Cancer
Date applied
10/07/2018
Date assigned
19/07/2018
Last edited
09/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Colorectal cancer is one of the most common cancers worldwide, and the risk of its development increases with age. It is therefore of great importance to undertake preventive measures against colorectal cancer in order to reduce its increasing prevalence. Undergoing cancer screening is one of the most effective ways of preventing the development of colorectal cancer through early detection, leading to increased chances of successful treatment and survival. Despite the proven benefits of cancer screening, studies showed that South Asian ethnic minorities, both in Hong Kong and worldwide, do not tend to use the publicly available cancer screening services, resulting in a higher chance of these individuals developing colorectal cancer, particularly among older adults. It was shown that their reduced tendency to undergo cancer screening is partly contributed by their low level of health knowledge and barriers to accessing health and cancer preventive services. In view of this, educational programmes are required to educate older South Asians ethnic minorities on the importance of cancer screening. With studies showing that younger family members educated on the importance of cancer screening are more able to recommend their older family members to undergo cancer screening, such an education programme should be targeted for families rather than older adults alone. This study aims to develop a multimedia health promotion programme for families of South Asian ethnic minorities in Hong Kong, to increase their awareness of the importance of undergoing cancer screening in colorectal cancer prevention.

Who can participate?
Pairs of healthy South Asian (Indian, Pakistani and Nepali) adults living in Hong Kong, comprising a younger family member aged between 18 and 61 and an older family member aged between 62 and 71

What does the study involve?
Each pair of participants is randomly allocated into either group A or group B. Participants in group A receive the educational programme. It is delivered in one session using multiple means including a health talk on colorectal cancer and cancer screening, presentation of a video clip depicting the benefits of family support in motivating an older family member to undergo cancer screening, and a health information booklet. Participants in group B receive this programme after those in group A have completed the programme. For participants in both groups, before and after group A participants have received the programme, the researchers assess the following: whether the younger family members of each participant pair are willing to encourage their older family members to consult a family doctor for undertaking colorectal cancer screening, and are prepared to assist older family members in collecting samples for colorectal cancer screening; whether the older family members of each participant pair have seen a family doctor for an appointment in colorectal cancer screening. The researchers also assess whether participants in both groups are satisfied with the programme after they have attended it.

What are the possible benefits and risks of participating?
The immediate benefit for the participants receiving the educational programme will be their increased awareness of the importance of undertaking cancer screening. They will be empowered to use cancer screening more regularly, enabling them to prevent colorectal cancer more effectively. No risks of physical or mental harm are expected.

Where is the study run from?
The programme will be run at South Asian community centres, ethnic minority associations and non-governmental organisations that provide support services for local South Asians, in various districts of Hong Kong

When is the study starting and how long is it expected to run for?
September 2018 to August 2020

Who is funding the study?
Food and Health Bureau, The Government of the Hong Kong Special Administrative Region

Who is the main contact?
Prof. Winnie K.W. So

Trial website

Contact information

Type

Scientific

Primary contact

Prof Winnie KW So

ORCID ID

Contact details

Room 731
Esther Lee Building
The Chinese University of Hong Kong
Shatin
Hong Kong SAR
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of a family-based multimedia intervention on the uptake of colorectal cancer screening among South Asian older adults in Hong Kong: a randomised control trial

Acronym

Study hypothesis

The intervention will be effective in enhancing the utilisation rate of colorectal cancer screening among South Asians in Hong Kong.

Ethics approval

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee, 02/02/2018, CREC Ref no: 2017.536-T

Study design

Prospective randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Colorectal cancer

Intervention

Each pair of participants will be assigned into either group A or group B. Participants in group A will receive the educational programme. It is delivered in one session, using multiple means including a health talk on colorectal cancer and cancer screening, presentation of a video clip depicting the benefits of family support in motivating an older family member to undergo cancer screening and a health information booklet. Participants in group B (wait-list control group) will receive this programme after those in group A have completed the post-intervention follow-up data collection. For participants in both groups, the following parameters will be assessed before and after group A participants have received the programme: 1) Whether the younger family members of each participant pair are willing to encourage their older family members to consult a family doctor for undertaking colorectal cancer screening, and are prepared to assist older family members in collecting samples for colorectal cancer screening; 2) Whether the older family members of each participant pair have seen a family doctor for an appointment in colorectal cancer screening. The study will also assess whether participants in both groups are satisfied with the programme after they have attended it.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Uptake of fecal occult blood test (FOBT), measured by ‘number of South Asians aged 62-71 who go to see a family doctor with a stool sample’ / ‘total number of participants in each group’. Number of participants who provided a stool sample for FOBT will be determined from the record on whether a stool sample is delivered to the family doctor by the participants for the FOBT. This record will be taken about two months after the intervention is delivered.

Secondary outcome measures

1. Number of participants who consulted a family doctor for FOBT, determined from the participants’ record of attendance to the participants’ family doctors for consultation on FOBT. This record will be taken about one month after the intervention is delivered
2. Number of younger adults who express their willingness in encouraging their older family members or relatives aged between 62 and 71 to consult a family doctor for a FOBT, measured both at baseline (before the intervention) and immediately after the intervention is delivered
3. Number of younger adults who express their readiness to assist their older family members or relatives aged between 62 and 71 to collect a stool sample for FOBT, measured both at baseline (before the intervention) and immediately after the intervention is delivered

Overall trial start date

01/09/2018

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

South Asians (Indian, Pakistani or Nepalese) including younger family members/relatives aged 18 to 61, and older adults aged 62 to 71, living in Hong Kong

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

320 dyads

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2019

Recruitment end date

31/01/2020

Locations

Countries of recruitment

Hong Kong

Trial participating centre

South Asian community centres and non-governmental organizations in six districts (Wanchai, Sham Shui Po, Islands District, Yuen Long, Yau Tsim Mong, Tusen Wan) will be approached to ask for their support in subject recruitment
Hong Kong
-
Hong Kong

Sponsor information

Organisation

Food and Health Bureau, The Government of Hong Kong SAR

Sponsor details

Research Office
Food and Health Bureau
9/F
Rumsey Street Multi-storey Carpark Building
2 Rumsey Street
Sheung Wan
Hong Kong SAR
-
Hong Kong

Sponsor type

Government

Website

https://rfs1.fhb.gov.hk/english/funds/funds_hcpf/funds_hcpf_abt/funds_hcpf_abt.html

Funders

Funder type

Government

Funder name

Food and Health Bureau

Alternative name(s)

FHB

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Hong Kong

Results and Publications

Publication and dissemination plan

Documents including study protocol, statistical analysis plans and informed consent form will not be made publicly available, but they will be available upon request. Findings of the study will be disseminated through publications in internationally-refereed journals and presentations at local or international conferences, after the analysis of data has been performed.

Updated 09/04/2019:
The researchers plan to publish the study protocol associated with this study, and the results obtained from this study, in a peer-reviewed journal. They also plan to disseminate the study findings through presentations at local or international conferences.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/04/2019: Publication and dissemination plan and IPD sharing statement updated.