CancerNCT04592224
Cancer Information Your Way: Get What You Need to Make Your Decisions
An observational study of Cancer, run by University of Southampton at 1 site in United Kingdom.
Trial summary
People diagnosed with cancer may face many difficult decisions regarding their care and preferences. This may be particularly challenging when the cancer cannot be cured. It is therefore hugely important that patients have the information they need so that they can be involved in these decisions and in their care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2020to 30 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with incurable malignancy of any site, identified by their healthcare professionals as potentially having difficulties with health literacy
Who may be able to join
- Diagnosis of incurable malignancy of any site (as identified by their treating oncologist and may be characterised by eligibility for or receipt of treatment with palliative intent)
- Identified by a member of the healthcare team as potentially having difficulties with health literacy
- Capacity to provide informed consent
- English as the main language
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Information Your Way: Get What You Need to Make Your Decisions - a Qualitative Study of Decision Making by Patients With Lower Health Literacy Receiving Care for Incurable Cancer
People diagnosed with cancer may face many difficult decisions regarding their care and preferences. This may be particularly challenging when the cancer cannot be cured. It is therefore hugely important that patients have the information they need so that they can be involved in these decisions and in their care.
This qualitative interview study aims to hear from patients who might have found that the information they were given wasn't easy to understand, or who haven't been able to get involved in their care as much as they would have liked. We hope to learn from these experiences in order to improve the way patients are given information and supported to become involved in their care.
Read the detailed description
Participants will be identified by healthcare professionals and invited to take part in a single interview either by phone or video call, lasting around an hour.
Interviews will be semi-structured and follow a topic guide, exploring how participants have been given information, how decisions have been made, and any particular challenges they may have faced.
Consent will also be sought for collection of demographic and disease data from the participant's medical record
- Conditions
- Cancer
- Keywords
- Health literacy
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interviews
To explore how best to support decision making by patients with lower health literacy receiving care for incurable cancer, acknowledging the implications COVID-19 will have for future care delivery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Nov 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloe E Holden, MBBCh, Principal investigator, Poole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592224
- Sponsor's protocol ID
- 60486
- Status last verified
- Jul 2022
- First submitted
- 15 Oct 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Information Your Way: Get What You Need to Make Your Decisions - a Qualitative Study of Decision Making by Patients With Lower Health Literacy Receiving Care for Incurable Cancer
- ClinicalTrials.gov ID
- NCT04592224
- Acronym / sponsor ID
- 60486
- Conditions
- Cancer
- Keywords
- Health literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 19 Oct 2020 (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.
People diagnosed with cancer may face many difficult decisions regarding their care and preferences. This may be particularly challenging when the cancer cannot be cured. It is therefore hugely important that patients have the information they need so that they can be involved in these decisions and in their care.
This qualitative interview study aims to hear from patients who might have found that the information they were given wasn't easy to understand, or who haven't been able to get involved in their care as much as they would have liked. We hope to learn from these experiences in order to improve the way patients are given information and supported to become involved in their care.
Detailed description
Participants will be identified by healthcare professionals and invited to take part in a single interview either by phone or video call, lasting around an hour.
Interviews will be semi-structured and follow a topic guide, exploring how participants have been given information, how decisions have been made, and any particular challenges they may have faced.
Consent will also be sought for collection of demographic and disease data from the participant's medical record
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with incurable malignancy of any site, identified by their healthcare professionals as potentially having difficulties with health literacy
Key inclusion criteria (4 listed)
- Diagnosis of incurable malignancy of any site (as identified by their treating oncologist and may be characterised by eligibility for or receipt of treatment with palliative intent)
- Identified by a member of the healthcare team as potentially having difficulties with health literacy
- Capacity to provide informed consent
- English as the main language
Key exclusion criteria (0 listed)
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
Semi-structured interviews
Time frame: 1 year
To explore how best to support decision making by patients with lower health literacy receiving care for incurable cancer, acknowledging the implications COVID-19 will have for future care delivery.
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 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Chloe E Holden, MBBCh principal investigator
Poole Hospital
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 University of Southampton 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 4 inclusion and 0 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 20 Jul 2022. 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?
Semi-structured interviews (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.