Holistic Needs Assessment in Outpatient Cancer Care

NCT02274701 | Unknown

• 1 other identifier: 14/WS/0126
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oncology [See Also, Affected System]

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Shared decision making

  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

  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..

Study Arms (2)

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.

Other: Holistic Needs Assessment

Control

NO INTERVENTION

The control group entails standard care - routine consultation between the patient and clinician.

Interventions

Holistic Needs Assessment OTHER

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.

Also known as: The Concerns Checklist

Holistic Needs Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18, capable of informed consent and expresses a wish to participate.
• Diagnosed with cancer and attending a post-treatment out-patient oncology clinic.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the West of Scotland: lead
• Macmillan Cancer Support: collaborator

Related Publications (4)

• 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.

  PMID: 22875264 BACKGROUND

• 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.

  PMID: 21471860 BACKGROUND

• Snowden 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.

  PMID: 37142317 DERIVED

• 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.

  PMID: 25967990 DERIVED

Study Officials

• Austyn Snowden, PhD

  University of the West of Scotland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austyn Snowden

CONTACT

Austyn.Snowden@uws.ac.uk

Jenny Young

CONTACT

01418494121; Jenny.Young@uws.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs Jenny Young

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 27, 2014

Record last verified: 2014-10