The Goals of Care Initiative

NCT ID: NCT04020679

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2021-01-11

Brief Summary

A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI & sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice.

Conditions

Decision-Making Oncology; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control arm

Participants will not receive GOCI materials

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants will receive GOCI materials and clinicians will receive training.

Group Type: EXPERIMENTAL

Goals of Care Initiative

Intervention Type: BEHAVIORAL

Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process. Furthermore, there will be instructional videos on how to complete the Goal conversations sheet. Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams. The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams. The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet. The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care.

Interventions

Goals of Care Initiative

Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process. Furthermore, there will be instructional videos on how to complete the Goal conversations sheet. Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams. The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams. The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet. The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care.

Intervention Type: BEHAVIORAL

Other Intervention Names

Can-GUIDE

Eligibility Criteria

Inclusion Criteria

• Undergoing, or being considered for, systemic treatment from one of the cluster teams.
• 18+ years.
• Able to give written consent.
• Able to understand verbal and written English.

Exclusion Criteria

• Patient is not being considered for Systemic Anti-Cancer Treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janelle Yorke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

18_CPCR_17

Identifier Type: -

Identifier Source: org_study_id