Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them
Abstract
:1. Introduction
2. Methods
2.1. Reporting and Ethics
2.2. Survey Development
2.3. Survey Content
2.4. Recruitment and Sample Frame
2.5. Survey Administration
2.6. Data Cleaning
2.7. Analysis
3. Results
4. Discussion
Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
TDF | Theoretical Domains Framework |
CBCN | Canadian Breast Cancer Network |
CTO | Clinical Trials Ontario |
QuIC | Quality of Informed Consent |
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N | Percent | ||
---|---|---|---|
Gender | Male | 2 | 0.8% |
Female | 238 | 97.5% | |
Transgender/non-binary | 0 | 0% | |
Prefer not to answer | 0 | 0% | |
Missing | 4 | 1.6% | |
Age | Range (31–84) | Mean (SD) 57.0 (11.5) | |
Geographic location | Ontario | 100 | 41.0% |
Western Canada | 68 | 27.9% | |
Eastern Canada | 41 | 16.8% | |
Quebec/Northern Canada | 33 | 13.5% | |
Missing | 2 | 0.8% | |
Education | Some high school | 4 | 1.6% |
High school diploma | 13 | 5.3% | |
Some university/college | 42 | 17.2% | |
College diploma/BA degree | 122 | 50.0% | |
Graduate degree | 30 | 12.3% | |
Doctoral degree | 8 | 3.3% | |
Professional degree | 12 | 4.8% | |
Other | 2 | 0.8% | |
Prefer not to answer | 2 | 0.8% | |
Missing | 9 | 3.7% | |
Household income | Less than $50,000 | 40 | 16.4% |
$50,000 or more but less than $100,000 | 81 | 33.2% | |
$100,000 or more but less than $150,000 | 26 | 10.7% | |
$150,000 or more | 30 | 12.3% | |
Prefer not to answer | 52 | 21.3% | |
Missing | 15 | 6.1% | |
Ethnicity | White/Caucasian | 223 | 91.4% |
Asian | 3 | 1.2% | |
South Asian | 3 | 1.2% | |
Black | 2 | 0.8% | |
Arab/West Asian | 0 | 0% | |
First Nations/Indigenous | 4 | 1.6% | |
Filipino | 0 | 0% | |
Latin American | 1 | 0.4% | |
Other (e.g., participant reported) | 5 | 2.0% | |
Prefer not to answer | 3 | 1.2% | |
Months in Canada previous year | 9 Plus months | 233 | 95.5% |
6–9 months | 3 | 1.2% | |
Less than 3 months | 2 | 0.8% | |
Prefer not to answer | 3 | 1.2% | |
Missing | 3 | 1.2% | |
Language spoken at home | English | 179 | 73.4% |
French | 41 | 16.8% | |
Other | 19 | 7.8% | |
Missing | 5 | 2.0% | |
Employment | Retired | 94 | 38.5% |
Full-time employment | 66 | 27.0% | |
Long-term disability | 37 | 15.2% | |
Self employed | 20 | 8.2% | |
Part-time employment | 19 | 7.8% | |
Other | 24 | 9.8% | |
Prefer not to answer | 6 | 2.5% | |
Respondents with breast cancer | 225 | 92.2% | |
Early stage | 104 | 46.2% | |
Late stage | 91 | 40.4% | |
Don’t know | 22 | 9.8% | |
Missing/no response | 8 | 3.6% | |
Respondents were family member with breast cancer | 14 | 5.7% |
Question | N (% Total) |
---|---|
Responded ‘no’ to being approached for research | 129 (54.0%) |
Responded ‘yes’ to being approached for research | 97 (40.6%) |
Responded ‘no’ to ever participating in research | 134 (56.1%) |
Responded ‘yes’ to ever participating in research | 91 (38.1%) |
What did participation involve? | |
Clinical trial | 43 (47.3%) |
Survey | 52 (57.1%) |
Interview | 20 (22.0%) |
Database study | 40 (44.0%) |
Don’t know | 0 (0.0%) |
Other | 12 (13.2%) |
Confidence in clinical trial knowledge? | |
Not at all confident | 13 (5.4%) |
Not very confident | 24 (10.0%) |
Somewhat confident | 115 (48.1%) |
Completely confident | 83 (34.7%) |
Missing | 4 (1.7%) |
Responded ‘yes’ to having actively looked for a clinical trial | 65 (27.2%) |
Searched online | 57 (87.7%) |
Asked a health care provider | 37(56.9%) |
Spoke to other patients | 16 (24.6%) |
Other | 5 (7.7%) |
Responded ‘yes’ to having help in search | 16 (24.6%) |
Help from doctor | 6 (37.5%) |
Help from other patients | 2 (12.5%) |
Other help | 7 (43.8%) |
Missing | 1 (6.3%) |
Responded ‘yes’ to finding a study to participate in | 13 (20.0%) |
Responded ‘yes’ to desire for search navigator | 53 (81.5%) |
Statement | Perceived as Barrier | Perceived as Enabler | |||
---|---|---|---|---|---|
A Lot | A Little | No Effect | A Little | A Lot | |
Social Influences | |||||
If the investigators provided regular study updates | 1 (0.5%) | 0 (0%) | 10 (4.9%) | 89 (43.2%) | 106 (51.5%) |
If my physician (s) thought I should participate | 0 (0%) | 0 (0%) | 13 (6.3%) | 76 (37.1%) | 116 (56.6%) |
If there were helpful people on hand to help you make your participation decision | 0 (0%) | 2 (1.0%) | 17 (8.2%) | 96 (46.4%) | 92 (44.4%) |
If my family thought I should participate | 0 (0%) | 1 (0.5%) | 39 (19.1) | 100 (49.0%) | 64 (31.4%) |
If my physician was paid to recruit patients into the study | 122 (59.5%) | 41 (20.0%) | 38 (18.5%) | 3 (1.5%) | 1 (0.5%) |
My feelings about whether the trial funders can be trusted | 23 (11.3%) | 31 (15.2%) | 46 (22.5%) | 46 (22.5%) | 58 (28.4%) |
My worry that participation would mean that others would find out about my condition | 8 (3.9%) | 9 (4.4%) | 175 (85.4%) | 9 (4.4%) | 4 (2.0%) |
Belief about Consequences | |||||
My hope that participation will help me with my condition | 0 (0%) | 0 (0%) | 3 (1.5%) | 33 (16.1%) | 169 (82.4%) |
My belief that participating would help others | 0 (0%) | 0 (0%) | 5 (2.5%) | 85 (41.9%) | 113 (55.7%) |
My belief that participating would contribute to science | 0 (0%) | 0 (0%) | 13 (6.3%) | 104 (50.0%) | 91 (43.8%) |
My belief that I would receive better care if I participated | 1 (0.5%) | 0 (0%) | 31 (14.9%) | 101 (48.6%) | 75 (36.1%) |
If I had to stay longer in hospital | 40 (19.5%) | 78 (38.0%) | 78 (38.0%) | 5 (2.4%) | 4 (2.0%) |
If I had to have more biopsies | 28 (13.8%) | 63 (31.0%) | 99 (48.8%) | 5 (2.5%) | 8 (3.9%) |
If I had to have more blood tests | 9 (4.4%) | 32 (15.7%) | 147 (72.1%) | 9 (4.4%) | 7 (3.4%) |
Belief about Capabilities | |||||
If I think my cancer prognosis is poor | 13 (6.2%) | 6 (2.9%) | 17 (8.1%) | 52 (24.9%) | 121 (57.9%) |
My belief that participating would give me a sense of control over what is happening to me | 0 (0%) | 4 (2.0%) | 28 (13.7%) | 86 (42.0%) | 87 (42.4%) |
If I think my health is good (other than my cancer) | 15 (7.2%) | 16 (7.7%) | 55 (26.3%) | 74 (35.4%) | 49 (23.4%) |
My feelings about the quality of my drug plan | 12 (5.9%) | 29 (14.1%) | 112 (54.6%) | 30 (14.6%) | 21 (10.2%) |
Reinforcement | |||||
If I received the results of the study once it was complete | 1 (0.5%) | 3 (1.5%) | 14 (6.9%) | 84 (41.4%) | 101 (49.8%) |
If I would gain access to new study drugs | 1 (0.5%) | 4 (1.9%) | 17 (8.3%) | 77 (37.7%) | 105 (51.5%) |
If the study reimbursed expenses | 1 (0.5%) | 0 (0%) | 38 (18.2%) | 94 (45.0%) | 76 (36.4%) |
My experience with previous trials | 2 (1.0%) | 9 (4.4%) | 138 (67.3%) | 27 (13.2%) | 29 (14.1%) |
Goals | |||||
If I think participation would affect my social life/family commitments | 37 (18.0%) | 106 (51.7%) | 58 (28.3%) | 2 (1.0%) | 2 (1.0%) |
My belief that participation would prevent me from my other activities | 39 (18.7%) | 98 (46.9%) | 65 (31.1%) | 4 (1.9%) | 3 (1.4%) |
My belief that participation would interfere with other goals of mine | 36 (17.6%) | 102 (49.0%) | 64 (31.4%) | 2 (1.0%) | 2 (1.0%) |
If I think participation would interfere with my childcare responsibilities | 33 (16.1%) | 42 (20.5%) | 129 (62.9%) | 1 (0.5%) | 0 (0%) |
Environmental Context and Resources | |||||
If there were patient-friendly decision-making tools to help you make your participation decision | 0 (0%) | 1 (0.5%) | 28 (13.4%) | 107 (51.2%) | 73 (34.9%) |
If the study provided transportation to/from study appointments | 0 (0%) | 1 (0.5%) | 75 (35.9%) | 63 (30.1%) | 70 (33.5%) |
If I think there is a substantial time commitment | 31 (14.9%) | 79 (38.0%) | 80 (38.5%) | 11 (5.3%) | 7 (3.4%) |
My feelings about the quality of the health care system | 11 (5.4%) | 30 (14.7%) | 103 (50.5%) | 43 (21.1%) | 17 (8.3%) |
Skills | |||||
If I find the trial documents hard to understand | 64 (30.8%) | 87 (41.8%) | 48 (23.1%) | 6 (2.9%) | 3 (1.4%) |
If the consent documents describe probabilities of side effects and numbers of patients affected by them | 17 (8.1%) | 76 (36.4) | 62 (29.7%) | 36 (17.2%) | 18 (8.6%) |
Social/Professional Role and Identity | |||||
My belief that participating would give me a sense of purpose | 1 (0.5%) | 1 (0.5%) | 48 (23.1%) | 96 (46.2%) | 62 (29.8%) |
My belief that participation is part of my role as a good citizen | 8 (3.9%) | 4 (1.9%) | 68 (32.9%) | 77 (37.2%) | 50 (24.2%) |
Knowledge | |||||
My belief that I’d learn more about my condition if I participated | 0 (0%) | 1 (0.5%) | 24 (11.5%) | 104 (50.0%) | 79 (38.0%) |
Optimism | |||||
My hope that participation would help find a cure | 0 (0.0%) | 1 (0.5%) | 4 (2.0%) | 54 (26.3%) | 146 (71.2%) |
Memory, Attention and Decision Processes | |||||
If the investigators provided telephone reminders about study appointments | 1 (0.5%) | 3 (1.4%) | 100 (48.1%) | 71 (34.1%) | 33 (15.9%) |
Emotion | |||||
My worry about unknown side effects | 50 (24.0%) | 119 (57.2%) | 30 (14.4%) | 7 (3.4%) | 2 (1.0%) |
Reported Research Experience | Comparison (p Value) | ||
---|---|---|---|
Yes | No | ||
Confidence in clinical trial knowledge, N = 234 | 91 | 143 | χ2 (1) = 6.77 (p = 0.009) |
Yes | 84 (92.3%) | 114 (79.7%) | |
No | 7 (7.7%) | 29 (20.3%) | |
Knowledge about clinical trials score, M (SD) | 9.8 (1.5) | 8.8 (2.0) | t (223) = −3.90 (p = 0.000) |
My belief that participation is part of my role as a good citizen, N = 205 | 81 | 124 | χ2 (2) = 7.81 (p = 0.02) |
Enabler to trial participation | 59 (72.8%) | 68 (54.8%) | |
Barrier to trial participation | 5 (6.2%) | 7 (5.6%) | |
No effect | 17 (21.0%) | 49 (39.5%) | |
If there was patient-friendly decision-making tools to help you make your participation decision, N = 207 | 82 | 125 | χ2 (2) = 11.32 (p = 0.003) |
Enabler to trial participation | 63 (76.8%) | 115 (92.0%) | |
Barrier to trial participation | 0 (0%) | 1 (0.8%) | |
No effect | 19 (23.2%) | 9 (7.2%) | |
My experience with previous trials, N = 203 | 80 | 123 | χ2 (2) = 23.27 (p = 0.000) |
Enabler to trial participation | 37 (46.3%) | 19 (15.4%) | |
Barrier to trial participation | 4 (5.0%) | 7 (5.7%) | |
No effect | 39 (48.8%) | 97 (78.9%) |
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Share and Cite
Brehaut, J.C.; Carroll, K.; Gordon, J.; Presseau, J.; Richards, D.P.; Fergusson, D.A.; Graham, I.D.; Marlin, S. Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them. Curr. Oncol. 2021, 28, 2014-2028. https://doi.org/10.3390/curroncol28030187
Brehaut JC, Carroll K, Gordon J, Presseau J, Richards DP, Fergusson DA, Graham ID, Marlin S. Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them. Current Oncology. 2021; 28(3):2014-2028. https://doi.org/10.3390/curroncol28030187
Chicago/Turabian StyleBrehaut, Jamie C., Kelly Carroll, Jenn Gordon, Justin Presseau, Dawn P. Richards, Dean A. Fergusson, Ian D. Graham, and Susan Marlin. 2021. "Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them" Current Oncology 28, no. 3: 2014-2028. https://doi.org/10.3390/curroncol28030187