CancerORCANCT05479851
ORCA: Opportunities to Raise Cancer Awareness After Referral: Survey of Patient Views
An observational study of Cancer, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate what patients think about increasing provision of advice about how to detect cancer early and how to reduce their future cancer risk after they are discharged from a two-week wait referral pathway for suspected cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 406 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults >18 years old who have been referred through the two-week wait pathway for suspected cancer, and who have received a negative diagnosis (i.e. informed of a 'ruling out of cancer' according to the new 28-day faster diagnosis standard).
Who may be able to join
- Adults >18 years old
- Referred through the two-week wait pathway for suspected cancer
- Received a negative diagnosis (i.e. informed of a 'ruling out of cancer' according to the new 28-day faster diagnosis standard) within the past 1-3 months
Who cannot join
- Adults who have been diagnosed with cancer
- Adults who have not yet been informed of their results from their urgent referral
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate what patients think about increasing provision of advice about how to detect cancer early and how to reduce their future cancer risk after they are discharged from a two-week wait referral pathway for suspected cancer. This study will send a postal survey to patients living in the UK who were recently referred onto the suspected cancer pathway and were discharged without a cancer diagnosis (i.e. a negative diagnosis). Patients will be presented with different types of support and patients' views of the burden, benefits, understanding and perceived effectiveness of each one will be measured.
Read the detailed description
In England, over 2 million patients are referred each year on urgent two-week wait (TWW) pathways to rule-out cancer of a single anatomical site. Referrals have increased by around 10% per year since 2015 (with the exception of 2020, due to the COVID-19 pandemic). The vast majority of those referred (93%) do not have cancer diagnosed. There is mounting evidence that patients who have previously experienced a symptom that after investigation turned out to be benign, often delay seeking help for subsequent symptoms. This is thought to occur because of over-reassurance from the previous 'all-clear' result leading to subsequent symptoms being interpreted as benign (extending the appraisal interval), concern about appearing hypochondriacal, not wanting to further bother the doctor or about the appropriate next actions. This is likely to be compounded by the impact of COVID-19 on help-seeking decisions and has implications for service provision. There may be scope to provide tailored support to those who are initially discharged without a cancer diagnosis to avoid missing cancers at other anatomical sites and to ensure subsequent cancers are diagnosed in a timely manner, at an early stage, or even prevented. For instance, patients could be offered information on common cancer signs, when/how to seek help for ongoing or new symptoms, facilitation to take part in cancer screening, and preventative advice. Indeed, referral for suspected cancer may be an under-utilised 'teachable moment' when people are more responsive and receptive to health information. There is currently a lack of support for those with a negative diagnosis after a TWW referral. Qualitative work indicates that there is currently no standardised approach to the information patients receive from healthcare professionals about future cancer risk or how to respond to new or recurring symptoms. It is important to assess feasibility and acceptability of interventions prior to evaluation of effectiveness. This allows implementation strategies to be incorporated into the design of interventions that will increase adoption and sustainment as well as being appropriate to the setting, providers and recipients. Yet at present it is not known what the feasibility and acceptability is of interventions linked to the TWW pathway. The objective of the proposed research is to obtain this information.
- Conditions
- Cancer
- Keywords
- Cancer early diagnosis, Cancer awareness, Cancer risk reduction behaviour, Health Behaviour
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UK National Health Service Patient Postal Survey Participants | Patients who have agreed to participate in the study after receiving a postal invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' prospective acceptability ratings of different types of cancer advice and support interventions using a thirteen-item scale
Prospective acceptability (perceived acceptability prior to intervention participation) of different cancer advice and support interventions, will be compared using scores obtained from a 13-item scale reflecting the domains of the Theoretical Framework of Acceptability (Scott et al 2021).
Measured: cross sectional questionnaire to be completed 1-3 months after urgent referral
Secondary outcomes (1)
Proportions of participants willing to receive each type of advice/ support, after discharge from a two week wait (urgent referral) pathway
Comparison of the willingness of participants from different two week wait pathways to receive different types of advice/ support. Willingness will be assessed using a one-item measure (Stevens et al 2019, Prev Med; Stevens et al, 2019, Lung Cancer).
Measured: cross sectional questionnaire to be completed 1-3 months after urgent referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start7 Oct 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479851
- Sponsor's protocol ID
- 303199
- Acronym
- ORCA
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will obtain consent for electronic copies of anonymised non-personally identifiable data (e.g. questionnaire responses) to be archived, shared and available for secondary analysis via a data sharing repository (e.g. King's College London (KCL) data repository). Data will be uploaded to the repository upon acceptance of publication or within 3 months of the end of the funding, whichever occurs earliest.
Publications
Scott SE, Rauf B, Waller J. "Whilst you are here..." Acceptability of providing advice about screening and early detection of other cancers as part of the breast cancer screening programme. Health Expect. 2021 Oct;24(5):1868-1878. doi: 10.1111/hex.13330. Epub 2021 Aug 8.
PubMed 34369071Stevens C, Vrinten C, Smith SG, Waller J, Beeken RJ. Acceptability of receiving lifestyle advice at cervical, breast and bowel cancer screening. Prev Med. 2019 Mar;120:19-25. doi: 10.1016/j.ypmed.2018.12.005. Epub 2018 Dec 19.
PubMed 30578909Stevens C, Smith SG, Quaife SL, Vrinten C, Waller J, Beeken RJ. Interest in lifestyle advice at lung cancer screening: Determinants and preferences. Lung Cancer. 2019 Feb;128:1-5. doi: 10.1016/j.lungcan.2018.11.036. Epub 2018 Nov 27.
PubMed 30642439
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORCA: Opportunities to Raise Cancer Awareness After Referral: Survey of Patient Views
- ClinicalTrials.gov ID
- NCT05479851
- Acronym / sponsor ID
- ORCA / 303199
- Conditions
- Cancer
- Keywords
- Cancer early diagnosis, Cancer awareness, Cancer risk reduction behaviour, Health Behaviour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate what patients think about increasing provision of advice about how to detect cancer early and how to reduce their future cancer risk after they are discharged from a two-week wait referral pathway for suspected cancer. This study will send a postal survey to patients living in the UK who were recently referred onto the suspected cancer pathway and were discharged without a cancer diagnosis (i.e. a negative diagnosis). Patients will be presented with different types of support and patients' views of the burden, benefits, understanding and perceived effectiveness of each one will be measured.
Detailed description
In England, over 2 million patients are referred each year on urgent two-week wait (TWW) pathways to rule-out cancer of a single anatomical site. Referrals have increased by around 10% per year since 2015 (with the exception of 2020, due to the COVID-19 pandemic). The vast majority of those referred (93%) do not have cancer diagnosed. There is mounting evidence that patients who have previously experienced a symptom that after investigation turned out to be benign, often delay seeking help for subsequent symptoms. This is thought to occur because of over-reassurance from the previous 'all-clear' result leading to subsequent symptoms being interpreted as benign (extending the appraisal interval), concern about appearing hypochondriacal, not wanting to further bother the doctor or about the appropriate next actions. This is likely to be compounded by the impact of COVID-19 on help-seeking decisions and has implications for service provision. There may be scope to provide tailored support to those who are initially discharged without a cancer diagnosis to avoid missing cancers at other anatomical sites and to ensure subsequent cancers are diagnosed in a timely manner, at an early stage, or even prevented. For instance, patients could be offered information on common cancer signs, when/how to seek help for ongoing or new symptoms, facilitation to take part in cancer screening, and preventative advice. Indeed, referral for suspected cancer may be an under-utilised 'teachable moment' when people are more responsive and receptive to health information. There is currently a lack of support for those with a negative diagnosis after a TWW referral. Qualitative work indicates that there is currently no standardised approach to the information patients receive from healthcare professionals about future cancer risk or how to respond to new or recurring symptoms. It is important to assess feasibility and acceptability of interventions prior to evaluation of effectiveness. This allows implementation strategies to be incorporated into the design of interventions that will increase adoption and sustainment as well as being appropriate to the setting, providers and recipients. Yet at present it is not known what the feasibility and acceptability is of interventions linked to the TWW pathway. The objective of the proposed research is to obtain this information.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UK National Health Service Patient Postal Survey Participants | – | –Patients who have agreed to participate in the study after receiving a postal invitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults >18 years old who have been referred through the two-week wait pathway for suspected cancer, and who have received a negative diagnosis (i.e. informed of a 'ruling out of cancer' according to the new 28-day faster diagnosis standard).
Key inclusion criteria (3 listed)
- Adults >18 years old
- Referred through the two-week wait pathway for suspected cancer
- Received a negative diagnosis (i.e. informed of a 'ruling out of cancer' according to the new 28-day faster diagnosis standard) within the past 1-3 months
Key exclusion criteria (2 listed)
- Adults who have been diagnosed with cancer
- Adults who have not yet been informed of their results from their urgent referral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants' prospective acceptability ratings of different types of cancer advice and support interventions using a thirteen-item scale
Time frame: cross sectional questionnaire to be completed 1-3 months after urgent referral
Prospective acceptability (perceived acceptability prior to intervention participation) of different cancer advice and support interventions, will be compared using scores obtained from a 13-item scale reflecting the domains of the Theoretical Framework of Acceptability (Scott et al 2021).
1 secondary outcome
Proportions of participants willing to receive each type of advice/ support, after discharge from a two week wait (urgent referral) pathway
Time frame: cross sectional questionnaire to be completed 1-3 months after urgent referral
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 34369071Scott SE, Rauf B, Waller J. "Whilst you are here..." Acceptability of providing advice about screening and early detection of other cancers as part of the breast cancer screening programme. Health Expect. 2021 Oct;24(5):1868-1878. doi: 10.1111/hex.13330. Epub 2021 Aug 8.
- Background: PubMed 30578909Stevens C, Vrinten C, Smith SG, Waller J, Beeken RJ. Acceptability of receiving lifestyle advice at cervical, breast and bowel cancer screening. Prev Med. 2019 Mar;120:19-25. doi: 10.1016/j.ypmed.2018.12.005. Epub 2018 Dec 19.
- Background: PubMed 30642439Stevens C, Smith SG, Quaife SL, Vrinten C, Waller J, Beeken RJ. Interest in lifestyle advice at lung cancer screening: Determinants and preferences. Lung Cancer. 2019 Feb;128:1-5. doi: 10.1016/j.lungcan.2018.11.036. Epub 2018 Nov 27.
- Individual participant dataSharing planned: Yes. We will obtain consent for electronic copies of anonymised non-personally identifiable data (e.g. questionnaire responses) to be archived, shared and available for secondary analysis via a data sharing repository (e.g. King's College London (KCL) data repository). Data will be uploaded to the repository upon acceptance of publication or within 3 months of the end of the funding, whichever occurs earliest.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' prospective acceptability ratings of different types of cancer advice and support interventions using a thirteen-item scale (time frame: cross sectional questionnaire to be completed 1-3 months after urgent referral). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479851, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.