NCT Number: NCT07498829
PROTECT-C is a research study offering genetic testing to people to see whether they have a genetic change that increases their risk of breast, ovary, bowel, and/or womb cancer. This is regardless of whether they or their families have had cancer.
Breast, ovary, bowel, and womb cancers make up half of all cancers in women. Around 15-20% (15 to 20 in 100 cases) of ovary and 3-4% (3 to 4 in 100 cases) of breast, womb, and bowel cancers are linked to cancer genes and may be prevented. People with a genetic change that puts them at increased risk of any of these cancers have ways to help them manage their risk through the NHS. This may include screening to find cancers earlier when they are easier to treat, and surgery or medication to prevent cancers from developing. This can save lives.
Currently, genetic testing is only available on the NHS to people who meet certain criteria. For example, those who have had certain cancers, have a strong family history of cancer, or those with Jewish ancestry. But many people may not have a strong family history or meet NHS testing criteria. This means that this system of testing misses 50% to 80% of people (50 to 80 in 100 people) who have a genetic change. It is thought that only around 3 in 100 people overall who have a genetic change that increases their risk of cancer know about it. Given the effective screening and preventive options that are available, this represents a huge, missed opportunity to prevent cancers or find them earlier.
The PROTECT-C study aims to evaluate the option of offering genetic testing to everyone who may want it. This is regardless of whether they or their families have had cancer. We will offer genetic testing to 5000 people. People may take part if they:
* Are over the age of 18 years and * Are a woman, trans man, or non-binary person with female reproductive organs (ovaries, fallopian tubes, and/or a uterus) and * Have never had genetic testing for the cancer genes tested for in the study and * Do not have first-degree family members (e.g.: parent, sibling, child) or second-degree family members (e.g.: aunt, uncle, niece, nephew, grandchild, grandparent, half-sibling) with genetic changes in the cancer genes tested for in the study
PROTECT-C is a completely digital study. The study team will give participants access to an app developed specifically for this study. They can download this app using a smartphone or tablet or access it on any internet browser using a computer or laptop. Before they can access the app, participants will need to complete a consent form. They will also be asked to fill in a short questionnaire about themselves and their health. The PROTECT-C app contains information to help participants decide if they would like to have genetic testing. If they decide to have genetic testing, they will complete a consent form for genetic testing on the app. The study team will send them a saliva based test kit in the post.
The study will look at how many people decide to have genetic testing and how many of them are found to have a genetic change. It will evaluate their experience with using the app and how this approach to genetic testing affects their quality-of-life, satisfaction, and mental well-being. This will give us a better understanding of how well the app works as a way of offering genetic testing to people. The study is interested to see how people found to be at increased risk decide to manage their risk. We will assess the uptake of screening and prevention options. Few participants will be invited to have 1:1 interviews by the study team. This will evaluate their experience of making a decision about genetic testing and taking part in the study. Taking part in these interviews is optional. The study will also assess if this way of offering genetic testing to people is affordable for the NHS.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
London, EC1M 6BQ, United Kingdom
Location status: Recruiting
Caitlin Fierheller, PhD
CONTACT
Ranjit Manchanda, PhD
CONTACT
Ranjit Manchanda, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk for all women (including trans-men, and non-binary individuals with female reproductive organs) over the age of 18 years independent of any family or personal history of cancer.
Time frame: 1 year after completing recruitment
The primary outcome measure is the proportion of women with one or more CSGs who have undergone genetic testing and received a valid result.
PV prevalence will be estimated by the number of observed PVs divided by the total number of individuals tested. An overall rate and CSG specific rates will be calculated. Standard NHS criteria at time of the study (i.e. Amsterdam-2 Criteria for Lynch Syndrome and 10% BRCA probability threshold for HBOC) will be used to evaluate family history criteria for genetic testing. The proportion of PVs fulfilling NHS testing criteria (FH positive) will be estimated. 95% Confidence Intervals for these outcomes will be calculated as per methods specified in the SAP (statistical analysis plan).
Time frame: measured at acceptance, 21 days, 6 months and 12 months
Satisfaction is measured as the proportion of positive responses to the statement "I am satisfied with the decision I have made"
Time frame: measured at acceptance, 21 days, 6 months and 12 months
Regret is measured as the proportion who score 10 or less using the Decision Regret Scale questionnaire (scale 5-25 where 5 indicates completely dissatisfied and 25 indicates completely satisfied).
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Quality of Life is measured using the EORTC Questionnaire EQ5D- 5L. Mean score (range 0-1) with higher scores indicating higher quality of life.
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
a. Cancer worry score is measured using the Cancer Worry Scale questionnaire (4-item Cancer Worry Scale questionnaire on a 4-point Likert scale). Mean Cancer Worry Scale score (range 4-16) and self-reported VAS score (range 0-100); with higher score indicates greater concern
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Risk perception is measured as the proportion responding as at "high or much higher" chance of cancer to the statement "compared with other people of your age, do you think your chances of getting cancer at some point in your life are…"
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire- Anxiety score (7-item questionnaire on a 4-point Likert scale).
Depression is measured using the HADS depression questionnaire -(7-item questionnaire on a 4-point Likert scale).
Scores range from 0-21 with higher scores indicating higher levels of anxiety/depression.
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Distress is measured using the Impact of Events (IES) questionnaire (22-item IES questionnaire on a 5-point Likert scale). Mean score IES Intrusive scale (range 0-35) and IES Avoidance scale (range 0-38); where higher scores indicate greater distress.
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Impact is measured using the Multidimensional Impact of Cancer (MICRA) questionnaire. Mean score overall (range 0 -105) with separate scores for distress, positive experiences and uncertainty. MICRA distress scale (range 0-30), MICRA positive experiences scale (range 0-20) and MICRA uncertainty scale (range 0-45); where higher scores indicates higher impact.
Time frame: collected annually over 8 years
Uptake of risk management options (for breast, ovarian, endometrial and bowel cancers) are measured using self-reported, clinical and/or registry data
Time frame: 2 years post return of last result in those recruited
Uptake of cascade testing is measured as the total number of people who undergo cascade testing per family in an individual with a PV in a CSG at 2 years after the return of the last test result
Time frame: 6 months after return of the last test result
measured as the proportion of VUS carriers in women who have undergone testing at 6 months after return of the last test result
Time frame: 12 months after return of last test result - initial analysis
Is measured by incremental cost-effectiveness ratio (ICER) comparing population testing strategy with a family history based testing strategy. ICER per QALY is compared to the NICE willingness to pay threshold in the UK (£30,000/QALY). Incremental costs, incremental QALYs and number of cancers/deaths prevented will be calculated and one-way and probabilistic sensitivity analysis undertaken.
Time frame: 6 months after return of the last test result
Proportion of women with who consent to undergo genetic testing (amongst those consenting to the study) 6 months after return of the last test result.
Time frame: 6 months after return of the last test resut.
Number of women categorised as moderate or high risk for BC or moderate or high risk for OC using the CAN-RISK model Number of women categorised as moderate or high risk for BC using the Tyrer-Cuzick model Number of women categorised as moderate or high risk of BC using the Tyrer-Cuzick model, and difference compared with use of the CAN-RISK model
Time frame: 6 months after return of the last test result.
PV prevalence for "individual" CSG : BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6 calculated by Proportion of women who have undergone genetic testing and found to have a "specific" CSG Proportion of women identified as FH positive in women who test positive with PVs in "individual" CSGs
Time frame: Years 2, 3 post-test result
Satisfaction: 1-item ("I am satisfied with the decision I have made") on a 5-point Likert scale Regret: Score as calculated from the 5-item Decision Regret Scale on a 5-point Likert scale. Measured as the proportion who score 10 or less using the Decision Regret Scale questionnaire (scale 5-25 where 5 indicates completely dissatisfied and 25 indicates completely satisfied).
Time frame: 6-month post-test result (or decision not to test in decliners)
9-questions from App Evaluation Questionnaire. Evaluated separately for women who accept and decline genetic testing using. Accept/decline and 6-month post-test questionnaire.
Time frame: Accept/decline, 21-days and 6-month post-test questionnaire
Helpline evaluation questionnaire and telephone or booking system record database.
b. Reasons for helpline use- Proportion of consented women who called by reason c. Mode of helpline use - Proportion of calls by mode of use d. Ease of access - Proportion who found the helpline "very easy or easy" to use in those who used the helpline e. Satisfaction- Proportion who were "very satisfied or satisfied" with the helpline in those who used the helpline
Time frame: Accept/decline, 21-days and 6-month post-test questionnaire
Helpline evaluation questionnaire and telephone or booking system record database.
a. Frequency of use of helpline- Total number of calls and proportion of consented women who contacted the helpline f. Frequency of use of booking system- Total number of people who used the online booking system
Time frame: baseline questionnaire and 6-month post-test questionnaire, as well as 1-3 year questionnaire
specific measures on Lifestyle and Behaviours using a customised questionnaire. Measuring average change in proportions between the baseline questionnaire and 6-month post-test questionnaire, as well as 1-3 year questionnaire in women who consent to genetic testing.
Time frame: baseline questionnaire and 6-month post-test questionnaire, as well as 1-3 year questionnaire
specific measures on Lifestyle and Behaviours using a customised questionnaire. Measuring average change in proportions between the baseline questionnaire and 6-month post-test questionnaire, as well as 1-3 year questionnaire in women who consent to genetic testing.
Time frame: baseline questionnaire and 6-month post-test questionnaire, as well as 1-3 year questionnaire
specific measures on Lifestyle and Behaviours using a customised questionnaire. Measuring average change in proportions between the baseline questionnaire and 6-month post-test questionnaire, as well as 1-3 year questionnaire in women who consent to genetic testing.
Time frame: For decliners - Baseline (post decision) For those with a PV or moderate or high risk result - Baseline (post decision), 9-12 months post decision For VUS: Baseline (post decision), 12-18 months post decision
Qualitative interview transcripts. Nvivo will be used to identify themes, index, chart, map, synthesize and interpret data, including comparison between relevant groups.
Time frame: End of study (end of year 8)
VUS reclassification recorded on the study database (updated every 6-months) and returned to participant.
Time frame: End of study (end of year 8)
VUS reclassification recorded on the study database (updated every 6-months) and returned to participant.
Time frame: 6 months post last recruit.
Performance uptake report. Proportion of individuals who registered on the website and indicated they received a letter, who could be linked to which type (one of two) of letter. To be reported at 6 months.
Time frame: Reported at 6 months after recruitment completed.
Self-reported letter type within the registration questionnaire. Difference in proportions of those who received each letter and registered from those invited, by letter type. To be reported at 6 months
Time frame: 6 months post last test result.
Measures on the first questionnaire including:
Time frame: baseline, 6 months, 1 year, 2 year, 3 years
Quality of life measured using EORTC EQ5D-5L score (5 domains each with 5 levels). Mean EQ5D score (range 0-1) with higher score indicating higher quality of life.
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing
Time frame: baseline, 6 months, 1 year, 2 year, 3 years
Quality of life measured using self-reported Visual Analogue Scale (VAS) score (range 0-100) with higher score indicating higher quality of life.
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing
Time frame: Pre-genetic testing, 6months, 1 year, 2 years, 3 years
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing.
Mean cancer Worry Scale score (4-item Cancer Worry Scale questionnaire on a 4-point Likert scale) (range 4-16) with higher score indicates greater concern.
Time frame: Pre-genetic testing, 6months, 1 year, 2 years, 3 years
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing.
Risk perception is measured as the proportion responding as at "high or much higher" chance of cancer to the statement "compared with other people of your age, do you think your chances of getting cancer at some point in your life are…"
Time frame: Pre-genetic testing, 6months, 1 year, 2 years, 3 years
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing.
Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire- Anxiety score (7-item questionnaire on a 4-point Likert scale). Depression is measured using the HADS depression questionnaire -(7-item questionnaire on a 4-point Likert scale). Scores range from 0-21 with higher scores indicating higher levels of anxiety/depression.
Time frame: Pre-genetic testing, 6months, 1 year, 2 years, 3 years
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing.
Distress is measured using the Impact of Events (IES) questionnaire (22-item IES questionnaire on a 5-point Likert scale). Mean score IES Intrusive scale (range 0-35) and IES Avoidance scale (range 0-38); where higher scores indicate greater distress.
Time frame: Pre-genetic testing, 6months, 1 year, 2 years, 3 years
Evaluation of change in proportions/average scores between pre-genetic testing questionnaires, 6-months and 1-3 years post-test questionnaires in women who consent to genetic testing.
Impact is measured using the Multidimensional Impact of Cancer (MICRA) questionnaire. Mean score overall (range 0 -105) with separate scores for distress, positive experiences and uncertainty. MICRA distress scale (range 0-30), MICRA positive experiences scale (range 0-20) and MICRA uncertainty scale (range 0-45); where higher scores indicates higher impact.
Contact information is provided by the study sponsor or research team.
Caitlin Fierheller, PhD
CONTACT
Ranjit Manchanda, PhD
CONTACT
Queen Mary University of London
Other
Acronym: PROTECT-C
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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