Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Informed Consent for Palliative Chemotherapy: Development of a Regimen-Specific Multi-Media Informed Consent Library To Promote Patient-Centered Decision-Making About Treatment of Advanced Gastrointestinal Cancers
Brief Summary: Patients are routinely asked to sign an "informed consent" document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many patients and caregivers note that these conversations are less useful than they could be. The informed consent process and its associated documents suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials focus on individual drugs instead of regimens; 3) information is presented in written instead of alternative written/audiovisual format; and 4) the patient perspective is lacking.

The overarching objective of this project is to develop a library of communication tools for the most common chemotherapy regimens used to treat advanced gastrointestinal cancers. Tools will include video clips and written documents that can be readily distributed, modified, and customized. This toolkit will be crafted in collaboration with oncologists and patients living with gastrointestinal cancer and improves upon existing resources in several ways: 1) balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3) use of both written and video format, and 4) inclusion of the patient perspective (e.g. video clips of patients describing their experience). A panel of oncologist and patient stakeholders will evaluate the acceptability of the tools. The investigators will then conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves the quality of informed consent for palliative chemotherapy. If effective, the tools will be amenable to broad dissemination via patient accessible cancer education websites and oncology clinics.


Options:
A: Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention Group; Type: OTHER; Interventions: Other: Transition program | Intervention Type: OTHER; Name: Transition program; Assigned to Arm(s): Intervention Group
B: Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Care | Arm Label: Assigned to palliative care team; Type: EXPERIMENTAL; Interventions: Behavioral: Assigned to palliative care team | Intervention Type: BEHAVIORAL; Name: Assigned to palliative care team; Assigned to Arm(s): Assigned to palliative care team | Intervention Type: BEHAVIORAL; Name: Usual Care; Assigned to Arm(s): Usual care
C: Arm Label: Usual informed consent; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual, standard-of-care informed consent for chemotherapy | Arm Label: Investigational informed consent; Type: EXPERIMENTAL; Interventions: Other: Investigational informed consent for chemotherapy | Intervention Type: OTHER; Name: Investigational informed consent for chemotherapy; Assigned to Arm(s): Investigational informed consent | Intervention Type: OTHER; Name: Usual, standard-of-care informed consent for chemotherapy; Assigned to Arm(s): Usual informed consent
D: Arm Label: Supportive Information Team Group; Type: EXPERIMENTAL; Interventions: Behavioral: Supportive Information Team Group | Arm Label: Usual Care Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Supportive Information Team Group; Assigned to Arm(s): Supportive Information Team Group

Answer: C