Breast CarcinomaNCT05021172
Incorporating ePrognosis for the Encouragement of Smarter Screening for Breast and Colorectal Cancer in Older Adults
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Breast Carcinoma and Colorectal Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This clinical trial assesses the feasibility and acceptability of a smarter screening intervention for breast and colorectal cancer in older adults. This study aims to learn more about how to support patients and physicians in making cancer screening decisions for older adults. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Colorectal Carcinoma
- What is being tested?
- Best Practice, Informational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2021to 30 Jun 2022
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 70 years and above
- Ability to understand study procedures and to comply with them for the entire length of the study
- Ability of individual to understand a written informed consent document, and the willingness to sign it
- Have no prior history of cancer
- Scheduled for an upcoming appointment in University of California, San Francisco (UCSF) General Internal Medicine or Women's Health Primary Care clinics
- English-speaking
Who cannot join
- Contraindication to any study-related procedure or assessment
- Non-English speaking
- Are under the current medical care of either the study primary investigator (PI) or co-investigator (Co-I)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Incorporating ePrognosis to Encourage "Smarter Screening" for Breast and Colorectal Cancer in Older Adults
This clinical trial assesses the feasibility and acceptability of a smarter screening intervention for breast and colorectal cancer in older adults. This study aims to learn more about how to support patients and physicians in making cancer screening decisions for older adults.
Read the detailed description
PRIMARY OBJECTIVES:
- Complete development of and refine "Smarter Screening", a multi-component, patient-centered intervention centered around ePrognosis: Cancer Screening to facilitate shared decision-making screening discussions for breast and colorectal cancer in older adults.
II. Assess feasibility and acceptability of the "Smarter Screening" intervention and assess its impact versus usual care on shared decision-making about whether or not to continue breast and colorectal cancer (CRC) screening among multi-ethnic and socioeconomically diverse primary care patients.
EXPLORATORY OBJECTIVES:
- Impact on breast and CRC screening versus usual care.
II. Risk perception, worry, and a patient-reported measure of decision quality.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.
ARM II: Participants receive usual care before scheduled primary care visit.
After completion of study, participants are followed up at 1 week post primary care visit.
- Conditions
- Breast Carcinoma, Colorectal Carcinoma
- Being tested
- Best Practice, Informational Intervention, Questionnaire Administration, Survey Administration
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Informational InterventionOther
Receive Passport to Health booklet
Questionnaire AdministrationOther
Complete ePrognosis
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Passport to Health booklet, ePrognosis) | Experimental | Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Participants receive usual care before scheduled primary care visit. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants enrolled
Ability to successfully recruit the target of approximately 40 patients will be determined by the overall number of participants who were screened for enrollment compared to the overall number of participants who were randomized to one of the groups.
Measured: 6 months
Proportion of primary care physicians (PCPs) enrolled
Ability to successfully recruit PCPs will be determined by the overall number of physicians who were contacted compared to the overall number of physicians who actively participated over the course of the study.
Measured: 6 months
Percentage of participants enrolled at 6 months
The investigators aim to attain at least 75% of recruited patients in each arm at the 6 month follow-up.
Measured: 6 months
Proportion of participants who received an ePrognosis report
The proportion of participants who received an ePrognosis report will be reported
Measured: 6 months
Proportion of physicians who utilized the ePrognosis clinician report
All enrolled intervention PCPs will receive a web-based survey after each patient visit to record whether the physicians used and/or discussed ePrognosis in that visit. The proportion of physicians who use the ePrognosis clinician report in their cancer screening counseling with participants/patients will be reported
Measured: 6 months
Responses to Qualitative Acceptability survey
A survey will be provided to PCPs and used to measure acceptability of the ePrognosis report by asking patients and providers to provide feedback about the intervention, including likes and dislikes, and future recommendation of using the report provided.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start24 Aug 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Zion Health Fund
- Responsible party
- Sponsor
- Investigators
- Judith M Walsh-Cassidy, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021172
- Sponsor's protocol ID
- 21051
- Other IDs
- NCI-2021-08493
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2021
- Last updated
- 11 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating ePrognosis to Encourage "Smarter Screening" for Breast and Colorectal Cancer in Older Adults
- ClinicalTrials.gov ID
- NCT05021172
- Acronym / sponsor ID
- 21051
- Conditions
- Breast Carcinoma, Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mount Zion Health Fund
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Aug 2021 (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.
This clinical trial assesses the feasibility and acceptability of a smarter screening intervention for breast and colorectal cancer in older adults. This study aims to learn more about how to support patients and physicians in making cancer screening decisions for older adults.
Detailed description
PRIMARY OBJECTIVES:
- Complete development of and refine "Smarter Screening", a multi-component, patient-centered intervention centered around ePrognosis: Cancer Screening to facilitate shared decision-making screening discussions for breast and colorectal cancer in older adults.
II. Assess feasibility and acceptability of the "Smarter Screening" intervention and assess its impact versus usual care on shared decision-making about whether or not to continue breast and colorectal cancer (CRC) screening among multi-ethnic and socioeconomically diverse primary care patients.
EXPLORATORY OBJECTIVES:
- Impact on breast and CRC screening versus usual care.
II. Risk perception, worry, and a patient-reported measure of decision quality.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.
ARM II: Participants receive usual care before scheduled primary care visit.
After completion of study, participants are followed up at 1 week post primary care visit.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Passport to Health booklet, ePrognosis) | Experimental | Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit. |
| Arm II (usual care) | Active comparator | Other: Best Practice, Other: Survey AdministrationParticipants receive usual care before scheduled primary care visit. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 70 years and above
- Ability to understand study procedures and to comply with them for the entire length of the study
- Ability of individual to understand a written informed consent document, and the willingness to sign it
- Have no prior history of cancer
- Scheduled for an upcoming appointment in University of California, San Francisco (UCSF) General Internal Medicine or Women's Health Primary Care clinics
Key exclusion criteria (3 listed)
- Contraindication to any study-related procedure or assessment
- Non-English speaking
- Are under the current medical care of either the study primary investigator (PI) or co-investigator (Co-I)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm II (usual care) |
| Informational InterventionReceive Passport to Health booklet | Other | Arm I (Passport to Health booklet, ePrognosis) |
| Questionnaire AdministrationComplete ePrognosis | Other | Arm I (Passport to Health booklet, ePrognosis) |
| Survey AdministrationAncillary studies | Other | Arm II (usual care) |
Primary outcome
Proportion of participants enrolled
Time frame: 6 months
Ability to successfully recruit the target of approximately 40 patients will be determined by the overall number of participants who were screened for enrollment compared to the overall number of participants who were randomized to one of the groups.
Proportion of primary care physicians (PCPs) enrolled
Time frame: 6 months
Ability to successfully recruit PCPs will be determined by the overall number of physicians who were contacted compared to the overall number of physicians who actively participated over the course of the study.
Percentage of participants enrolled at 6 months
Time frame: 6 months
The investigators aim to attain at least 75% of recruited patients in each arm at the 6 month follow-up.
Proportion of participants who received an ePrognosis report
Time frame: 6 months
The proportion of participants who received an ePrognosis report will be reported
Proportion of physicians who utilized the ePrognosis clinician report
Time frame: 6 months
All enrolled intervention PCPs will receive a web-based survey after each patient visit to record whether the physicians used and/or discussed ePrognosis in that visit. The proportion of physicians who use the ePrognosis clinician report in their cancer screening counseling with participants/patients will be reported
Responses to Qualitative Acceptability survey
Time frame: 6 months
A survey will be provided to PCPs and used to measure acceptability of the ePrognosis report by asking patients and providers to provide feedback about the intervention, including likes and dislikes, and future recommendation of using the report provided.
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 11 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.
Judith M Walsh-Cassidy, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Breast Carcinoma and Colorectal Carcinoma, run by University of California, San Francisco at 1 site in United States.
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 6 inclusion and 3 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 11 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 States. 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?
Proportion of participants enrolled (time frame: 6 months). The study lists 6 primary outcomes in all. 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 11 Jul 2022.