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Cancer Information Your Way: Get What You Need to Make Your Decisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592224
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
University of Southampton

Study Description
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Brief 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.

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.


Condition or disease
Cancer

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
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with incurable malignancy of any site, identified by their healthcare professionals as potentially having difficulties with health literacy
Criteria

Inclusion criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592224


Locations
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United Kingdom
Poole Hospital
Poole, Dorset, United Kingdom
Sponsors and Collaborators
University of Southampton
Investigators
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Principal Investigator: Chloe E Holden, MBBCh Poole Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT04592224    
Other Study ID Numbers: 60486
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southampton:
Health literacy