Oncology [See Also, Affected System]NCT02274701
Holistic Needs Assessment in Outpatient Cancer Care
A study testing Holistic Needs Assessment in people with Oncology [See Also, Affected System], run by University of the West of Scotland.
Trial summary
This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician communication in outpatient cancer care. Half of the participants will complete a HNA prior to their clinical consultation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology [See Also, Affected System]
- What is being tested?
- Holistic Needs Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Feb 2016
- 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
- Over 18, capable of informed consent and expresses a wish to participate.
- Diagnosed with cancer and attending a post-treatment out-patient oncology clinic.
Who cannot join
- Individuals not diagnosed with cancer.
- Non English speaker
- Person deemed incapable of consenting to participate as defined by the Adults with Incapacity Act (2000)
- Any reason which in the opinion of the clinician/investigator interferes with the ability of the patient to participate in the study
Trial locations and contacts
No sites are listed yet.
Austyn Snowden contact
About this study
Official title: Evaluating the Impact of Holistic Needs Assessment in Outpatient Cancer Care
This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician communication in outpatient cancer care. Half of the participants will complete a HNA prior to their clinical consultation. They will then take it into the consultation and it will inform a discussion around any identified areas of need. Half of the participants will be in the control group meaning there will be no additional intervention they will receive care as normal. The consultations will be audio-recorded. The patient will complete two outcome measures following the consultation.
Read the detailed description
Holistic needs assessment is a checklist completed by the patient prior to consultation. It signposts issues of emotional, practical, financial and clinical concern. The purpose of a HNA is to identify patient's individual needs in order to facilitate better collaboration. During consultation the HNA facilitates a dialogue that will have the patient's concerns at the centre. In conjunction with a subsequent care plan the process supports timely intervention based on a collaborative, person centred discussion. However, there is little evidence on how HNA impacts upon the dynamics of the clinical consultation. This study aims to establish a) how HNA affects the type of conversation that goes on during a clinical consultation and b) how these putative changes impact on shared decision-making and self-efficacy.
- Conditions
- Oncology [See Also, Affected System]
- Being tested
- Holistic Needs Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic Needs AssessmentOther
Also called The Concerns Checklist
An assessment completed by the patient in cancer care. It is recommended that this assessment is completed at key points in the care pathway, such as at diagnosis, post treatment and beginning of end of life care. The aim of this assessment is to allow the patient to discuss their most important needs as identified by them. The clinician will take any appropriate action. This may range from listening to the patient to referring to another member of the multi-disciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| Holistic Needs Assessment | Experimental | Participants (patients) complete a self-reported paper assessment that asks them to indicate whether they have any emotional, practical, financial and/or clinical concerns. The patient then takes this completed assessment into their consultation. It is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. A care plan is then written based on this assessment. Receives: Other: Holistic Needs Assessment |
| Control | No intervention | The control group entails standard care - routine consultation between the patient and clinician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient participation
Measured through analysis of the audio-recordings from each recorded consultation between a clinician and patient. Specifically, through measuring dialogue ratio and preponderance of initiative. These two measures indicate who is speaking, when and for how long.
Measured: This outcome measure will be collected during the patients first clinic appointment after treatment for their cancer. The consultation will last approximately 15 minutes.
Secondary outcomes (2)
Shared decision making
Measured through patient self-report using the measure CollaboRATE. CollaboRATE is a survey-based validated tool designed to create a fast way to measure how much effort clinicians make to explain their patients' health issues; how much effort they make to listen to the issues that matter most to their patients and how much effort they make to integrate the patients' views and health beliefs.
Measured: This outcome measure will be collected following the patients first clinic appointment after treatment. The patient will return to the researcher and complete this measure. It is expected to take no more than 1 minute to complete.
Self-efficacy
Measured through self-report using The Lorig Self-Efficacy for Managing Chronic Disease 6-Item Scale.
Measured: This outcome measure will be collected following the patients first clinic appointment after treatment. The patient will return to the researcher and complete this measure. It is expected to take no more than 5 minutes..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oncology [See Also, Affected System]Studies 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
- Parallel groups
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of Scotland
- Sponsor type
- University, hospital or other
- Collaborators
- Macmillan Cancer Support
- Responsible party
- Principal investigator, Jenny Young, University of the West of Scotland
- Investigators
- Austyn Snowden, PhD, Principal investigator, University of the West of Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274701
- Sponsor's protocol ID
- 14/WS/0126
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Snowden A, White CA, Christie Z, Murray E, McGowan C, Scott R. Helping the clinician help me: towards listening in cancer care. Br J Nurs. 2012 May 24-Jun 13;21(10):S18, S20-6. doi: 10.12968/bjon.2012.21.Sup10.S18.
PubMed 22875264Snowden A, White CA, Christie Z, Murray E, McGowan C, Scott R. The clinical utility of the distress thermometer: a review. Br J Nurs. 2011 Feb 24-Mar 9;20(4):220-7. doi: 10.12968/bjon.2011.20.4.220.
PubMed 21471860Snowden A, Young J, Roberge D, Schipani S, Murray E, Richard C, Lussier MT, White C. Holistic needs assessment in outpatient cancer care: a randomised controlled trial. BMJ Open. 2023 May 4;13(5):e066829. doi: 10.1136/bmjopen-2022-066829.
PubMed 37142317Snowden A, Young J, White C, Murray E, Richard C, Lussier MT, MacArthur E, Storey D, Schipani S, Wheatley D, McMahon J, Ross E. Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol. BMJ Open. 2015 May 11;5(5):e006840. doi: 10.1136/bmjopen-2014-006840.
PubMed 25967990
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Holistic Needs Assessment in Outpatient Cancer Care
- ClinicalTrials.gov ID
- NCT02274701
- Acronym / sponsor ID
- 14/WS/0126
- Conditions
- Oncology [See Also, Affected System]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- University of the West of ScotlandUniversity, hospital or other
- Collaborators
- Macmillan Cancer Support
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 24 Oct 2014 (estimated)
- 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.
This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician communication in outpatient cancer care. Half of the participants will complete a HNA prior to their clinical consultation. They will then take it into the consultation and it will inform a discussion around any identified areas of need. Half of the participants will be in the control group meaning there will be no additional intervention they will receive care as normal. The consultations will be audio-recorded. The patient will complete two outcome measures following the consultation.
Detailed description
Holistic needs assessment is a checklist completed by the patient prior to consultation. It signposts issues of emotional, practical, financial and clinical concern. The purpose of a HNA is to identify patient's individual needs in order to facilitate better collaboration. During consultation the HNA facilitates a dialogue that will have the patient's concerns at the centre. In conjunction with a subsequent care plan the process supports timely intervention based on a collaborative, person centred discussion. However, there is little evidence on how HNA impacts upon the dynamics of the clinical consultation. This study aims to establish a) how HNA affects the type of conversation that goes on during a clinical consultation and b) how these putative changes impact on shared decision-making and self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holistic Needs Assessment | Experimental | Other: Holistic Needs AssessmentParticipants (patients) complete a self-reported paper assessment that asks them to indicate whether they have any emotional, practical, financial and/or clinical concerns. The patient then takes this completed assessment into their consultation. It is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. A care plan is then written based on this assessment. |
| Control | No intervention | –The control group entails standard care - routine consultation between the patient and clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18, capable of informed consent and expresses a wish to participate.
- Diagnosed with cancer and attending a post-treatment out-patient oncology clinic.
Key exclusion criteria (4 listed)
- Individuals not diagnosed with cancer.
- Non English speaker
- Person deemed incapable of consenting to participate as defined by the Adults with Incapacity Act (2000)
- Any reason which in the opinion of the clinician/investigator interferes with the ability of the patient to participate in the study
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 |
|---|---|---|
| Holistic Needs AssessmentAlso: The Concerns ChecklistAn assessment completed by the patient in cancer care. It is recommended that this assessment is completed at key points in the care pathway, such as at diagnosis, post treatment and beginning of end of life care. The aim of this assessment is to allow the patient to discuss their most important needs as identified by them. The clinician will take any appropriate action. This may range from listening to the patient to referring to another member of the multi-disciplinary team. | Other | Holistic Needs Assessment |
Primary outcome
Patient participation
Time frame: This outcome measure will be collected during the patients first clinic appointment after treatment for their cancer. The consultation will last approximately 15 minutes.
Measured through analysis of the audio-recordings from each recorded consultation between a clinician and patient. Specifically, through measuring dialogue ratio and preponderance of initiative. These two measures indicate who is speaking, when and for how long.
2 secondary outcomes
Shared decision making
Time frame: This outcome measure will be collected following the patients first clinic appointment after treatment. The patient will return to the researcher and complete this measure. It is expected to take no more than 1 minute to complete.
Self-efficacy
Time frame: This outcome measure will be collected following the patients first clinic appointment after treatment. The patient will return to the researcher and complete this measure. It is expected to take no more than 5 minutes..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Background: PubMed 22875264Snowden A, White CA, Christie Z, Murray E, McGowan C, Scott R. Helping the clinician help me: towards listening in cancer care. Br J Nurs. 2012 May 24-Jun 13;21(10):S18, S20-6. doi: 10.12968/bjon.2012.21.Sup10.S18.
- Background: PubMed 21471860Snowden A, White CA, Christie Z, Murray E, McGowan C, Scott R. The clinical utility of the distress thermometer: a review. Br J Nurs. 2011 Feb 24-Mar 9;20(4):220-7. doi: 10.12968/bjon.2011.20.4.220.
- Derived from this study: PubMed 37142317Snowden A, Young J, Roberge D, Schipani S, Murray E, Richard C, Lussier MT, White C. Holistic needs assessment in outpatient cancer care: a randomised controlled trial. BMJ Open. 2023 May 4;13(5):e066829. doi: 10.1136/bmjopen-2022-066829.
- Derived from this study: PubMed 25967990Snowden A, Young J, White C, Murray E, Richard C, Lussier MT, MacArthur E, Storey D, Schipani S, Wheatley D, McMahon J, Ross E. Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol. BMJ Open. 2015 May 11;5(5):e006840. doi: 10.1136/bmjopen-2014-006840.
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.
Austyn Snowden contact
Austyn Snowden, PhD principal investigator
University of the West of Scotland
Questions about this trial
What is this clinical trial studying?
A study testing Holistic Needs Assessment in people with Oncology [See Also, Affected System], run by University of the West of Scotland.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Austyn Snowden (Austyn.Snowden@uws.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient participation (time frame: This outcome measure will be collected during the patients first clinic appointment after treatment for their cancer. The consultation will last approximately 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02274701, which also lists 4 linked publications.
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 27 Oct 2014.