TA-DA: a patient decision tool to help with treatment choices after second-line therapy
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
This project will test a patient decision aid (TA-DA) to help adults with advanced cancer who have already received at least two lines of palliative systemic therapy talk with their clinicians about third-line or later treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07009886 on ClinicalTrials.gov |
What this trial studies
The work will use a three-part approach: qualitative interviews with patients, caregivers, and clinicians to identify decision-making needs; a user-centered design process to create and refine the TA-DA tool; and a pilot randomized trial to estimate the tool's effect on patient knowledge about treatment options. The intervention is an educational communication aid intended to promote shared decision making for third-line or beyond palliative systemic therapy. Secondary outcomes will include measures of illness understanding, preparation for decision making, decisional conflict, quality of shared decision making, decisional regret, therapeutic alliance, and anxiety. The study is conducted at The University of Texas M. D. Anderson Cancer Center and includes clinician, patient, and caregiver participants.
Who should consider this trial
Good fit: Adults (18+) with advanced (metastatic, relapsed, or incurable) cancer who have received at least two prior lines of palliative systemic therapy, are English-speaking, able to make treatment decisions, and meet the study ECOG performance status criteria.
Not a fit: Patients who are not considering further systemic therapy, who have significant cognitive impairment, are non-English speakers, or who cannot meet the ECOG/functional criteria may not benefit from this decision aid.
Why it matters
Potential benefit: If successful, the TA-DA could help patients better understand their options and make treatment choices that match their goals and values.
How similar studies have performed: Similar patient decision aids in oncology have improved patient knowledge and reduced decisional conflict, but using a decision aid specifically for third-line or beyond palliative systemic therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Clinicians (Part I/II/III):
MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer
2. 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
* 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
3. 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
Exclusion Criteria:
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
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Hui, MD — M.D. Anderson Cancer Center
- Study coordinator: David Hui, MD
- Email: dhui@mdanderson.org
- Phone: (713) 792-6258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.