Holistic Needs Assessment in Outpatient Cancer Care

Oncology [See Also, Affected System] Clinical Trial

Official title:

Evaluating the Impact of Holistic Needs Assessment in Outpatient Cancer Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02274701
• Other study ID #: 14/WS/0126
• Status: Not yet recruiting
• Phase: N/A
• First received: October 16, 2014
• Last updated: October 24, 2014
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2014
• Source: University of the West of Scotland
• Contact: Austyn Snowden
• Email: Austyn.Snowden[@]uws.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18, capable of informed consent and expresses a wish to participate.

• Diagnosed with cancer and attending a post-treatment out-patient oncology clinic.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Oncology [See Also, Affected System]

Intervention

Other:
• Holistic Needs Assessment
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of the West of Scotland	Macmillan Cancer Support

References & Publications (2)

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. — View Citation

Snowden 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This outcome measure will be collected during the patients first clinic appointment after treatment for their cancer. The consultation will last approximately 15 minutes.	No
Secondary	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.	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.	No
Secondary	Self-efficacy	Measured through self-report using The Lorig Self-Efficacy for Managing Chronic Disease 6-Item Scale.	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..	No