Anatomic Stage I Breast Cancer AJCC v8NCT05049746
Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
A study testing Discussion, Interview and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study collects information and identifies decision making needs for older adult women with stage I-III breast cancer considering neoadjuvant and adjuvant chemotherapy. Using this information, a decision support tool is then developed to provide patients and physicians with tailored information regarding the risks… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Discussion, Interview and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2016to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patient Inclusion Criteria
- Women aged 65 years or older
- Must write and speak English
- Must have been diagnosed with Stage I-III breast cancer
- Must have made decision to either receive or not receive neoadjuvant or adjuvant chemotherapy
- Must be within 3 months of breast cancer neoadjuvant or adjuvant chemotherapy treatment decision
Show all 15Show fewer
- Self-reported no visual or auditory deficits
- SUBAIM 2b: Women aged 65 years or older
- SUBAIM 2b: Must write and speak English
- SUBAIM 2b: Must have been diagnosed with stage I-III breast cancer
- SUBAIM 2b: Must be a candidate for chemotherapy or targeted therapy (in the setting of HER2+ breast cancer)
- SUBAIM 2b: Must be making a decision regarding chemotherapy
- SUBAIM 2b: Self-reported no visual or auditory deficits
- PHYSICIAN INCLUSION CRITERIA
- Physician for patient recruited to participate in study (physician criteria)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Decision Making Needs for Older Adult Women With Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
This study collects information and identifies decision making needs for older adult women with stage I-III breast cancer considering neoadjuvant and adjuvant chemotherapy. Using this information, a decision support tool is then developed to provide patients and physicians with tailored information regarding the risks and benefits of chemotherapy and values clarification to support high-quality, shared decision. Subsequently, the decision support tool will be tested amongst older patients with early-stage breast cancer and health care providers navigating the decision process around chemotherapy, and further refined through an iterative process.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize and describe the informational needs and preferences in older adult women who intend on receiving neoadjuvant or adjuvant chemotherapy for stage I-III breast cancer.
Ia. Conduct semi-structured interviews with women who have completed the treatment decision process to collect informational needs and elicit decision-making needs and preferences.
Ib. Utilize validated data collection instruments to assess the shared decision-making process and health literacy needs.
II. To develop a decision support tool for use by patients and healthcare providers to guide the chemotherapy decision-making process in older women (>= 65) with early-stage breast cancer.
IIa. To conduct cognitive testing of the decision tool. IIb. To conduct a field test of the decision tool in order to demonstrate feasibility and acceptability in real-world clinical settings.
OUTLINE:
Patients undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes. Subsequently, a decision support tool will be developed consistent with standards for content development and evaluation from the International Patient Decision Aid Standards (IPDAS) Collaboration and implemented through an iterative process of design, development and evaluation to engage end users in its development. Once developed, field testing of the decision tool will be conducted to demonstrate feasibility and acceptability in real-world clinical setting, followed by pilot testing to evaluate the efficacy of the decision support tool.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Discussion, Interview, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionOther
Also called Discuss
Participate in discussion
InterviewOther
Participate in interview
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer.
These could be written information, graphics, videos, animations, or questionnaires.
This decision tool will personalize the decision to you specifically and support your decision-making process Receives: Other: Discussion; Other: Interview; Other: Questionnaire Administration |
| Non-Intervention Arm | No intervention | Participants undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision making needs assessment questionnaire
The mean score of the shared decision making questionnaire and its standard deviation along with the median and the range will be computed for both the patient and physician study population. Score Range-(0-4) 0-Not at all confident 4-very confident
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start23 Feb 2016
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan Karuturi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049746
- Sponsor's protocol ID
- 2016-0055
- Other IDs
- NCI-2021-07005, 2016-0055
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Decision Making Needs for Older Adult Women With Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05049746
- Acronym / sponsor ID
- 2016-0055
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 20 Sep 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 study collects information and identifies decision making needs for older adult women with stage I-III breast cancer considering neoadjuvant and adjuvant chemotherapy. Using this information, a decision support tool is then developed to provide patients and physicians with tailored information regarding the risks and benefits of chemotherapy and values clarification to support high-quality, shared decision. Subsequently, the decision support tool will be tested amongst older patients with early-stage breast cancer and health care providers navigating the decision process around chemotherapy, and further refined through an iterative process.
Detailed description
PRIMARY OBJECTIVES:
- To characterize and describe the informational needs and preferences in older adult women who intend on receiving neoadjuvant or adjuvant chemotherapy for stage I-III breast cancer.
Ia. Conduct semi-structured interviews with women who have completed the treatment decision process to collect informational needs and elicit decision-making needs and preferences.
Ib. Utilize validated data collection instruments to assess the shared decision-making process and health literacy needs.
II. To develop a decision support tool for use by patients and healthcare providers to guide the chemotherapy decision-making process in older women (>= 65) with early-stage breast cancer.
IIa. To conduct cognitive testing of the decision tool. IIb. To conduct a field test of the decision tool in order to demonstrate feasibility and acceptability in real-world clinical settings.
OUTLINE:
Patients undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes. Subsequently, a decision support tool will be developed consistent with standards for content development and evaluation from the International Patient Decision Aid Standards (IPDAS) Collaboration and implemented through an iterative process of design, development and evaluation to engage end users in its development. Once developed, field testing of the decision tool will be conducted to demonstrate feasibility and acceptability in real-world clinical setting, followed by pilot testing to evaluate the efficacy of the decision support tool.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Other: Discussion, Other: Interview, Other: Questionnaire AdministrationParticipants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process |
| Non-Intervention Arm | No intervention | –Participants undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Patient Inclusion Criteria
- Women aged 65 years or older
- Must write and speak English
- Must have been diagnosed with Stage I-III breast cancer
- Must have made decision to either receive or not receive neoadjuvant or adjuvant chemotherapy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| DiscussionAlso: DiscussParticipate in discussion | Other | Intervention Arm |
| InterviewParticipate in interview | Other | Intervention Arm |
| Questionnaire AdministrationComplete questionnaire | Other | Intervention Arm |
Primary outcome
Decision making needs assessment questionnaire
Time frame: through study completion, an average of 1 year
The mean score of the shared decision making questionnaire and its standard deviation along with the median and the range will be computed for both the patient and physician study population. Score Range-(0-4) 0-Not at all confident 4-very confident
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Meghan Karuturi principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Interview and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center 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 15 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Decision making needs assessment questionnaire (time frame: through study completion, an average of 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 7 Oct 2026.