Decision-Making OncologyGOCINCT04020679
The Goals of Care Initiative
A study testing Goals of Care Initiative in people with Decision-Making Oncology and Chemotherapy Effect, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision-Making Oncology, Chemotherapy Effect
- What is being tested?
- Goals of Care Initiative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2019to 11 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient is not being considered for Systemic Anti-Cancer Treatment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative
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
- Being tested
- Goals of Care Initiative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goals of Care InitiativeBehavioural
Also called Can-GUIDE
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Participants will not receive GOCI materials |
| Intervention | Experimental | Participants will receive GOCI materials and clinicians will receive training. Receives: Behavioral: Goals of Care Initiative |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDM-Q-9
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.
Measured: Immediately following intervention
Decision Conflict Scale
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).
Measured: Immediately following intervention
Secondary outcomes (2)
Decision Self Efficacy Scale
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.
Measured: Immediately following intervention, then at 6 weeks and 12 weeks.
EQ-5D-5L
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.
Measured: Immediately following intervention, then at 6 weeks and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start11 Jun 2019
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision-Making OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Cluster Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Janelle Yorke, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020679
- Sponsor's protocol ID
- 18_CPCR_17
- Acronym
- GOCI
- Status last verified
- Jun 2021
- First submitted
- 10 Jul 2019
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative
- ClinicalTrials.gov ID
- NCT04020679
- Acronym / sponsor ID
- GOCI / 18_CPCR_17
- Conditions
- Decision-Making Oncology, Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 220 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Participants will not receive GOCI materials |
| Intervention | Experimental | Behavioral: Goals of Care InitiativeParticipants will receive GOCI materials and clinicians will receive training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient is not being considered for Systemic Anti-Cancer Treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goals of Care InitiativeAlso: Can-GUIDECan-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. | Behavioural | Intervention |
Primary outcome
SDM-Q-9
Time frame: 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.
Decision Conflict Scale
Time frame: 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).
2 secondary outcomes
Decision Self Efficacy Scale
Time frame: Immediately following intervention, then at 6 weeks and 12 weeks.
EQ-5D-5L
Time frame: Immediately following intervention, then at 6 weeks and 12 weeks.
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janelle Yorke, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goals of Care Initiative in people with Decision-Making Oncology and Chemotherapy Effect, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDM-Q-9 (time frame: Immediately following intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.