Advanced CancerNCT07009886
Development of an Educational Patient Decision Aid (Treatments in Advanced Cancer - Decision Aid, TA-DA) to Promote Shared Decision Making for Third-line or Beyond Palliative Systemic Therapy
A study testing Communication in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2025to 31 Jul 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicians (Part I/II/III):
- MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer
- Patients (Part I/II/III):
- Age 18 or over
- Diagnosis of advanced cancer (i.e., metastatic, relapsed, and/or incurable disease as defined by the treating oncologist) who has received at least 2 lines of palliative systemic therapy*
- Patient-rated ECOG performance status of 1-3 for Part I/II and 2-3 for Part III
Show all 18Show fewer
- Able to make treatment decisions based on the clinical judgement of the oncology team
- English speaking
- patient has started, is receiving, and/or has completed second-line palliative systemic therapy or beyond
- Caregivers (Part I/II/III):
- Age 18 or older
- Currently a primary caregiver to a patient who satisfies the patient eligibility criteria listed above
- For the study purposes, a primary caregiver is defined as:
- someone who provides physical, emotional, decisional and/or logistical assistance to the patient regularly (e.g. daily, weekly);
- can be a family member, friend, or other individual in a close relationship with the patient;
- must be identified by the patient and self-identify as the primary person providing caregiving support to the patient
- Able to provide informed consent and participate in the study
- English speaking
Who cannot join
- Any patient who meets any of the following criteria will be excluded from participation in this study:
- (Part I/II/III): Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker as determined by the clinical team
- (Part III only): Participants in Part I and II
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
David Hui, MD, 713-792-6258, dhui@mdanderson.org
David Hui, MD
About this study
To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA).
Read the detailed description
Primary Objectives:
The study objective is to develop an educational patient DA (Treatments in Advanced cancer - Decision Aid, TA-DA) to assist patients, their caregivers, and clinicians to make an informed decision about third-line or beyond palliative systemic therapy for advanced cancer. To fulfill the study's objectives, we will complete 3 study parts:
Using qualitative methods, explore the decision-making needs of patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy; identify initial preferences and recommendations to inform the design of the educational patient DA in Part II.
Following a user-centered design approach, develop and measure the acceptability of an educational patient DA to promote shared decision making among patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy.
Conduct a pilot RCT to estimate the effect of the educational patient DA (TA-DA) on patient's knowledge of their treatment options.
Secondary Objectives:
Examine the impact of the educational patient DA (TA-DA) on patients' illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (Decisional Conflict Scale [DCS]), quality of the shared decision-making process (SDM Process Scale), decisional regret (decisional regret scale), therapeutic alliance (The Human Connection Scale [THC]), anxiety (Generalized Anxiety Disorder 7 [GAD-7]), final treatment choice, and end-of-life care outcomes (e.g., systemic therapy use in last month of life).
Examine the impact of the educational patient DA (TA-DA) on caregivers' knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision- making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).
Examine the acceptability (Ottawa Acceptability Scale) of the educational patient DA (TA-DA) among patients, caregivers, and oncologists in the educational patient DA group. Examine the acceptability (modified Acceptability of Intervention Measure [AIM]), appropriateness (Intervention Appropriateness Measure [IAM]), and feasibility (Feasibility of Intervention Measure [FIM]) of the educational patient DA (TA-DA) among clinicians in the educational patient DA group.
Exploratory Objective:
2.3.1. (Part III) Examine the impact of the educational patient DA (TA-DA) on the concordance between patient-caregiver dyads for knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision-making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).
- Conditions
- Advanced Cancer
- Being tested
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunicationOther
Participants meet with clinician
| Study group | Role | What they receive |
|---|---|---|
| TA-DA | Experimental | Patient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool. Receives: Other: Communication |
| EUC | Experimental | Patient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool. Receives: Other: Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 posted8 Jun 2025
- Study start10 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009886
- Sponsor's protocol ID
- 2025-0480
- Other IDs
- NCI-2025-03797
- Status last verified
- Aug 2026
- First submitted
- 30 May 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Educational Patient Decision Aid (Treatments in Advanced Cancer - Decision Aid, TA-DA) to Promote Shared Decision Making for Third-line or Beyond Palliative Systemic Therapy
- ClinicalTrials.gov ID
- NCT07009886
- Acronym / sponsor ID
- 2025-0480
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 8 Jun 2025 (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.
To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA).
Detailed description
Primary Objectives:
The study objective is to develop an educational patient DA (Treatments in Advanced cancer - Decision Aid, TA-DA) to assist patients, their caregivers, and clinicians to make an informed decision about third-line or beyond palliative systemic therapy for advanced cancer. To fulfill the study's objectives, we will complete 3 study parts:
Using qualitative methods, explore the decision-making needs of patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy; identify initial preferences and recommendations to inform the design of the educational patient DA in Part II.
Following a user-centered design approach, develop and measure the acceptability of an educational patient DA to promote shared decision making among patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy.
Conduct a pilot RCT to estimate the effect of the educational patient DA (TA-DA) on patient's knowledge of their treatment options.
Secondary Objectives:
Examine the impact of the educational patient DA (TA-DA) on patients' illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (Decisional Conflict Scale [DCS]), quality of the shared decision-making process (SDM Process Scale), decisional regret (decisional regret scale), therapeutic alliance (The Human Connection Scale [THC]), anxiety (Generalized Anxiety Disorder 7 [GAD-7]), final treatment choice, and end-of-life care outcomes (e.g., systemic therapy use in last month of life).
Examine the impact of the educational patient DA (TA-DA) on caregivers' knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision- making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).
Examine the acceptability (Ottawa Acceptability Scale) of the educational patient DA (TA-DA) among patients, caregivers, and oncologists in the educational patient DA group. Examine the acceptability (modified Acceptability of Intervention Measure [AIM]), appropriateness (Intervention Appropriateness Measure [IAM]), and feasibility (Feasibility of Intervention Measure [FIM]) of the educational patient DA (TA-DA) among clinicians in the educational patient DA group.
Exploratory Objective:
2.3.1. (Part III) Examine the impact of the educational patient DA (TA-DA) on the concordance between patient-caregiver dyads for knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision-making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA-DA | Experimental | Other: CommunicationPatient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool. |
| EUC | Experimental | Other: CommunicationPatient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Clinicians (Part I/II/III):
- MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer
- Patients (Part I/II/III):
- Age 18 or over
- Caregivers (Part I/II/III):
Key exclusion criteria (3 listed)
- Any patient who meets any of the following criteria will be excluded from participation in this study:
- (Part I/II/III): Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker as determined by the clinical team
- (Part III only): Participants in Part I and II
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 |
|---|---|---|
| CommunicationParticipants meet with clinician | Other | EUC, TA-DA |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 12 Aug 2026.
- MD Anderson Cancer Center WebsiteLink 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.
David Hui, MD 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 Communication in people with Advanced Cancer, 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 18 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: looking for participants now, as of the sponsor's last update on 12 Aug 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?
Contact David Hui, MD ((713) 792-6258, dhui@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (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 12 Aug 2026.