Stage II Breast CancerNCT05025748
Ask Questions (ASQ):Implementation of a Communication Intervention
A study testing Behavioral Intervention in people with Stage II Breast Cancer and Stage III Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 8 sites in United States.
Trial summary
This clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Breast Cancer, Stage III Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Aug 2021to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older
- Have a first appointment to see a medical oncologist at a Karmanos Cancer Institute (KCC) site for medical/systemic treatment for a new, confirmed diagnosis of stages I-IV cancer
- Speak and read English well enough to be able to understand consent documents
- Given the diverse population seen at KCI, we will make attempts to recruit a representative sample. Our strategy will be simply to ask recruiters to make special attempts to recruit a representative sample. If that strategy fails after the first 10 patients we will build in requirements that at least 25% of the patients self-identify as non-White
Who cannot join
- Not specified
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, 48706
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
Karmanos Cancer Institute
Detroit, Michigan, 48201
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
Karmanos Cancer Institute at McLaren Macomb
Mount Clemens, Michigan, 48043
Karmanos Cancer Institute at McLaren Central Michigan
Mount Pleasant, Michigan, 48858
Karmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan, 49770
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
About this study
Official title: Ask Questions (ASQ): Implementation of a Communication Intervention to Improve Patient-Oncologist Communication in the Outpatient Medical Oncology Setting
This clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.
Read the detailed description
Patient-centered communication is critical to providing high-quality care. In patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. However, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. Question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in Detroit, and have been shown to contribute to improved outcomes related to better communication quality. Using a RE-AIM framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "ASQ brochure". The ASQ brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. Investigators will recruit 225 patients and implement the ASQ brochure at seven Karmanos Cancer Center network sites. Participants are newly diagnosed patients with (Stages I-IV) cancer for which systemic therapy is likely a recommended treatment.
- Conditions
- Stage II Breast Cancer, Stage III Breast Cancer, Stage IV Breast Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer, Stage IV Colorectal Cancer
- Being tested
- Behavioral Intervention
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Questionnaire Administration
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Health services research (ASQ brochure) | Experimental | Patients receive ASQ brochure and complete questionnaires over 30 minutes at baseline, over 10 minutes pre-clinic visit, and over 30 minutes post-clinic visit. Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy in managing patient-physician interactions
20 items, 5-point Likert scale
Measured: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Secondary outcomes (4)
Change in knowledge related to the patient's cancer and treatment
6 investigator-developed questions; 5-point Likert scale (strongly disagree - strongly agree)
Measured: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Change in trust in physicians
generally (before) and in a specific physician (after): (5 items20 Likert scale)
Measured: Baseline (Time 1) to post-clinic visit (Time 3)
Change in distress
Distress thermometer (one item, Likert scale (no distress - extreme distress)
Measured: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Perceptions of the Question Prompt List
10 items, 5-point Likert scale
Measured: Post-meeting (Time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start25 Aug 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Eggly, Barbara Ann Karmanos Cancer Institute
- Investigators
- Susan Eggly, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025748
- Sponsor's protocol ID
- 2021-025
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ask Questions (ASQ): Implementation of a Communication Intervention to Improve Patient-Oncologist Communication in the Outpatient Medical Oncology Setting
- ClinicalTrials.gov ID
- NCT05025748
- Acronym / sponsor ID
- 2021-025
- Conditions
- Stage II Breast Cancer, Stage III Breast Cancer, Stage IV Breast Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer, Stage IV Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 27 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 implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.
Detailed description
Patient-centered communication is critical to providing high-quality care. In patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. However, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. Question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in Detroit, and have been shown to contribute to improved outcomes related to better communication quality. Using a RE-AIM framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "ASQ brochure". The ASQ brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. Investigators will recruit 225 patients and implement the ASQ brochure at seven Karmanos Cancer Center network sites. Participants are newly diagnosed patients with (Stages I-IV) cancer for which systemic therapy is likely a recommended treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (ASQ brochure) | Experimental | Behavioral: Behavioral InterventionPatients receive ASQ brochure and complete questionnaires over 30 minutes at baseline, over 10 minutes pre-clinic visit, and over 30 minutes post-clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years of age or older
- Have a first appointment to see a medical oncologist at a Karmanos Cancer Institute (KCC) site for medical/systemic treatment for a new, confirmed diagnosis of stages I-IV cancer
- Speak and read English well enough to be able to understand consent documents
- Given the diverse population seen at KCI, we will make attempts to recruit a representative sample. Our strategy will be simply to ask recruiters to make special attempts to recruit a representative sample. If that strategy fails after the first 10 patients we will build in requirements that at least 25% of the patients self-identify as non-White
Key exclusion criteria (1 listed)
- Not specified
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 |
|---|---|---|
| Behavioral InterventionAlso: Questionnaire AdministrationComplete questionnaires | Behavioural | Health services research (ASQ brochure) |
Primary outcome
Self-efficacy in managing patient-physician interactions
Time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
20 items, 5-point Likert scale
4 secondary outcomes
Change in knowledge related to the patient's cancer and treatment
Time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Change in trust in physicians
Time frame: Baseline (Time 1) to post-clinic visit (Time 3)
Change in distress
Time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Perceptions of the Question Prompt List
Time frame: Post-meeting (Time 3)
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 16 Aug 2023.
- 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.
Susan Eggly, PhD principal investigator
Wayne State University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in people with Stage II Breast Cancer and Stage III Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 8 sites 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 4 inclusion and 1 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Self-efficacy in managing patient-physician interactions (time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)). 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 16 Aug 2023.