The Anishinaabek Cervical Cancer Screening Study

ISRCTN	ISRCTN84617261
DOI	https://doi.org/10.1186/ISRCTN84617261
Protocol serial number	MOP - 119344
Sponsor	Thunder Bay Regional Research Institute (Canada)
Funder	Canadian Institutes of Health Research (Canada)

Submission date: 25/10/2013
Registration date: 03/12/2013
Last edited: 18/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Ontario First Nations women are two times as likely to be diagnosed with cervical cancer compared to the general population. Researchers think that poor participation in cervical screening or inadequate follow-up are related to the greater incidence of cervical cancer. In this study we will work with communities to learn about First Nations women's cervical screening preferences. We want to compare two types of cervical cancer screening in First Nations populations: Pap tests and at-home human papillomavirus (HPV) test kits.

Who can participate?
Women aged 25 to 69 years who are registered with or live in the participating communities listed at http://www.accssfn.com/faq.html in Northwest Ontario, Canada.

What does the study involve?
Participating communities were randomly allocated to a method of cervical screening to first offer women in their community: either Pap tests and at-home human papillomavirus (HPV) test kits. Community-based research assistants (CBRAs) help to implement the research in their respective communities, helping to recruit women and provide education. Educational events for community members are organized and facilitated by each CBRA. Eligible women will make appointments with their CBRA. At these appointments, participants learn about informed consent, complete the questionnaire, and participate in cervical screening. Culturally-mindful tools like posters, flyers and brochures provide information to community members about HPV, cervical cancer and the study.
Pap tests are scheduled with the local clinics, collaborating healthcare providers or family physicians. Collaborating healthcare providers visit communities that are more than 60 km away from a healthcare service to ensure that Pap tests can be offered to these communities. Self-sampling kits are offered at the individual appointments. Participants are encouraged to take their sample immediately and mail it for testing but they have the option of taking the kit home. Results of Pap and HPV tests will be communicated by participants' preferred healthcare providers. This communication will allow for results to be explained. Follow-up appointments can be scheduled with these healthcare providers.
After the first offer of cervical screening, the CBRAs will follow-up consenting participants to ask about their experiences. The Research Team also meets with community representatives to reflect on the first round of screening. After this turn-around period, the reverse method of screening (i.e. the method not offered in the first phase of screening) will be offered to non-responding women.

What are the possible benefits and risks of participating?
Participants will help inform culturally-sensitive and community-based cervical screening programming in Ontario. Participating in cervical screening will help women address health issues before they become serious. Cervical screening might help find cancer that has already started. Participants may worry less about their health by learning about their cervical cancer screening results. Some women may feel discomfort when attending a Pap test or collecting their own HPV sample. They also may feel embarrassed discussing sensitive topics like HPV or cervical cancer. This study promotes healthy cervical screening choices in First Nations communities. We hope to increase cervical screening participation and decrease cervical cancer incidence in First Nations women. This study will contribute to our understanding of the disease from a holistic perspective. We hope to find out why cancer rates are high in First Nations communities and what can be done to reduce them. We also hope to communicate our findings to a broad audience. We hope that we can help change cervical screening guidelines and health promotion programming.

Where is the study run from?
The study is centred at the Thunder Bay Regional Research Institute and Lakehead University in Thunder Bay, Ontario, Canada.

When is the study starting and how long is it expected to run for?
The study began in May 2013. Women will be invited to participate in cervical screening for 9-12 months.

Who is funding the study?
This study is funded by the Canadian Institute of Health Research (Canada).

Who is the main contact?
Dr Ingeborg Zehbe (principal investigator)
zehbei@tbh.net

Contact information

Dr Ingeborg Zehbe
Scientific

980 Oliver Road
Room 3118
Thunder Bay
P7B6V4
Canada

Email	zehbei@tbh.net

Study information

Primary study design	Interventional
Study design	Cluster-randomized two-armed trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Engaging First Nations women in cervical cancer screening: assessing factors related to screening and uptake of self-sampling
Study acronym	ACCSS
Study objectives	Our first hypothesis is that knowledge and attitude about cervical cancer and its prevention impact on screening behaviour. Our second hypothesis is that the option of self-collected sampling will increase participation in cervical cancer screening. On 16/03/2015 the overall trial end date was changed from 01/05/2014 to 31/08/2014.
Ethics approval(s)	Lakehead University Research Ethics Board, 01/05/2013, REB project #: 126 12-13; ROMEO 1463139
Health condition(s) or problem(s) studied	Cervical cancer
Intervention	Participating communities are randomized to a method of cervical screening to first offer women in their community who are between 25 and 69 years of age. In arm A, Pap tests are first offered (standard care in Ontario, 'control'), and in arm B women will be offered HPV self-collected tests ('intervention'). The method not offered in the first phase of screening will then be offered to non-responding women.
Intervention type	Other
Primary outcome measure(s)	1. To compare the proportions of women who participate in screening based on an offer of self-sampling versus an offer of attending for a Pap test. This will be measured after the first phase of cervical screening (approximately 4 months after baseline) and after the second phase of cervical screening (approximately 9-12 months after baseline - this is the final time point). We will use 'objective' measures, using reports from CytoBase, the provincial electronic database for Pap cytology, to capture the numerator of participants attending Pap tests, divided by the total number of participants offered to receive Pap tests. For HPV self-sampling, we'll use the number of HPV reports returned to the Research Team from the laboratory, divided by the number of participants who were offered HPV tests. We will also consider using other denominators, including the total number of women invited to participate, and estimates of the total number of women registered with the communities. 2. To compare the psychosocial impact of cervical screening based on a primary offer of self-testing with that based on a primary offer of a Pap test; psychosocial impact will be assessed by questionnaire at three time points (baseline; after the first round of screening - approximately 4 months after baseline; after the final round of screening - approximately 9-12 months after baseline). Psychosocial impact is measured using nine Likert scale questions (seven-point scale), which have been tailored from the TOMBOLA study, and one free text question that asks generally about additional comments.
Key secondary outcome measure(s)	1. To measure uptake of all types of cervical screening in 11 participating First Nations communities, represented by percentage of participants who undergo Pap tests or complete HPV self-sampling tests. This will be measured after the first phase of cervical screening (approximately 4 months after baseline) and after the second phase of cervical screening (approximately 9-12 months after baseline - this is the final time point). To evaluate the impact of screening barriers on the attendance for cervical screening, measured using questionnaire and clinical records. The numerators will be the sum of the outcome records (i.e. CytoBase records and HPV test laboratory records) divided by the total women invited, in addition to the total estimates of women in the communities. 2. To compare rates of self-reported screening attendance against objective measures of screening attendance (e.g. follow-up questionnaire will collect self-report of screening attendance). We will use self-report of screening attendance from the follow-up questionnaires at 4 months following baseline and at the final collection time point at approximately 9-12 months. The denominators will include the total number of women participating and the total number of women invited to participate, in addition to the total estimated numbers of women in the communities. 3. To measure the distribution of HPV types in the study population, measured by the number of each unique type of HPV divided by the total number of women who participated in self-sampling. We will use the genotyping data from the National Microbiology Laboratory to determine the proportions of women infected with particular strains of HPV, divided by the total samples received.
Completion date	31/08/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	400
Key inclusion criteria	Inclusion criteria (cluster level): 1. First Nations community in the Robinson Superior region in Northwest Ontario 2. Ratified research agreements signed with Thunder Bay Regional Research Institute Inclusion criteria (individual level): 1. Female participant 2. Between the ages of 25 and 69 years 3. Registered with one of the eleven participating First Nations communities (band membership as per the Indian Act) or currently living on the reserve 4. Must belong to Ontario Health Insurance Plan, a provincial insurance plan that ensures residents have universal coverage for medically necessary services
Key exclusion criteria	Exclusion criteria (individual level): 1. Currently pregnant (will be asked to provide sample after pregnancy) 2. Known total hysterectomy
Date of first enrolment	08/05/2013
Date of final enrolment	31/08/2014

Locations

Countries of recruitment

Canada

Study participating centre

Thunder Bay Regional Research Institute

Thunder Bay
P7B6V4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/10/2016		Yes	No
Protocol article	protocol	19/02/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/11/2016: Publication reference added.