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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

(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 design

Design model

Single group

Treatments tested in this trial

  • Communication

    Other intervention

    Participants meet with clinician

Treatment groups

155 Participants
are divided into 2 treatment groups
Group A: TA-DAExperimental treatment 1 intervention
Group B: EUCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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