Holistic Needs Assessment in Outpatient Cancer Care

• ClinicalTrials.gov Identifier: NCT02274701
• Recruitment Status: Unknown
• First Posted: October 24, 2014
• Last Update Posted: October 27, 2014
• Sponsor: University of the West of Scotland
• Collaborator: Macmillan Cancer Support
• Information provided by (Responsible Party): Jenny Young, University of the West of Scotland

Tracking Information

• First Submitted Date: October 16, 2014
• First Posted Date: October 24, 2014
• Last Update Posted Date: October 27, 2014
• Study Start Date: October 2014
• Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 21, 2014)

• 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. ]
  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.
• 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.. ]
  Measured through self-report using The Lorig Self-Efficacy for Managing Chronic Disease 6-Item Scale.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Holistic Needs Assessment in Outpatient Cancer Care
• Official Title: Evaluating the Impact of Holistic Needs Assessment in Outpatient Cancer Care
• Brief 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Supportive Care
• Condition: 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.

Other Name: The Concerns Checklist

Study Arms

• Experimental: Holistic Needs Assessment
  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.
  Intervention: Other: Holistic Needs Assessment
• No Intervention: Control
  The control group entails standard care - routine consultation between the patient and clinician.

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.
• 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. doi: 10.12968/bjon.2011.20.4.220.
• Snowden 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 21, 2014): 156
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2016
• Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02274701
• Other Study ID Numbers: 14/WS/0126
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jenny Young, University of the West of Scotland
• Original Responsible Party: Same as current
• Current Study Sponsor: University of the West of Scotland
• Original Study Sponsor: Same as current
• Collaborators: Macmillan Cancer Support

Investigators

• Principal Investigator: Austyn Snowden, PhD; University of the West of Scotland

• PRS Account: University of the West of Scotland
• Verification Date: October 2014