The Goals of Care Initiative

Not Applicable

Terminated

• Conditions: Decision-Making Oncology; Chemotherapy Effect
• Interventions: Behavioral: Goals of Care Initiative

• Registration Number: NCT04020679
• Lead Sponsor: The Christie NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-11
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Goals of Care Initiative	Participants will receive GOCI materials and clinicians will receive training.

Primary Outcome Measures

Name	Time	Method
Decision Conflict Scale	Immediately following intervention	Patient satisfaction with decision and overall decision conflict will be measured using the Ottawa Decisional Conflict Scale. The scale consists of 16 items with patients scoring themselves on a five point scale (0, Strongly Agree - 4, Strongly Disagree). The scale includes five subscales: uncertainty, support, values, informed, effective decision.; The total score and subscale scores are calculated by dividing the sum of the items by the number of items within that subscale and multiplying by twenty five (scored range from 0 to 100; 0 score indicates no decisional conflict, 100 indicates extremely high decisional conflict). This scale evaluates the quality of decision as outlined within internationally recognised guidelines to establish the effectiveness of decision aids. Furthermore, some of the subscales address evaluating the quality of the decision process (feeling informed about the options, clarity of values).
SDM-Q-9	Immediately following intervention	Patient involvement in decision making will be measured using the SDM-Q-9 questionnaire. The questionnaire contains nine items with respondents scoring on a six point scale (0 represents completely disagree to 5 which represents completely disagree) how much they agree with the presented statement. The highest score attainable, 45, represents the highest level of perceived Shared Decision Making and 0 represents no perceived involvement in Shared Decision Making.

Secondary Outcome Measures

Name	Time	Method
Decision Self Efficacy Scale	Immediately following intervention, then at 6 weeks and 12 weeks.	A patient's ability to make a decision about treatment (or decision self-efficacy) will be measured using the Ottawa Decision Self-Efficacy scale. The scale consists of 11 items where patients score themselves on a five point scale (0, not at all confident - 4, Very confident); high score indicates greater decision self-efficacy. The total score provides a global rating of self confidence in the patient's ability to engage with decision making regarding their treatment. The total score is calculated by summing the 11 items, dividing by 11 and then multiply by 25.
EQ-5D-5L	Immediately following intervention, then at 6 weeks and 12 weeks.	EQ-5D is a standardised instrument for use as a measure of health outcome and it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. The EuroQoL 5-level version (EQ-5D-5L) will be assessed to provide a preference based measure of health-related quality-of-life which will enable us to calculate a quality adjusted life-year (QALY) for use in the cost-effectiveness analysis. The preference weights to estimate utility values and QALYs will be those recommended by NICE at the time of data analysis.; Participants are asked to choose a statement which best relates to their current experience relating to the following health domains: mobility, self-care, ability to carry out usual activities, pain/discomfort, anxiety/depression.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom