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Holistic Needs Assessment in Outpatient Cancer Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274701
Recruitment Status : Unknown
Verified October 2014 by Jenny Young, University of the West of Scotland.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2014
Last Update Posted : October 27, 2014
Sponsor:
Collaborator:
Macmillan Cancer Support
Information provided by (Responsible Party):
Jenny Young, University of the West of Scotland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oncology [See Also, Affected System] Other: Holistic Needs Assessment Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Official Title: Evaluating the Impact of Holistic Needs Assessment in Outpatient Cancer Care
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
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.
 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
No Intervention: Control
The control group entails standard care - routine consultation between the patient and clinician.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274701


Contacts
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Contact: Austyn Snowden Austyn.Snowden@uws.ac.uk
Contact: Jenny Young 01418494121 Jenny.Young@uws.ac.uk

Sponsors and Collaborators
University of the West of Scotland
Macmillan Cancer Support
Investigators
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Principal Investigator: Austyn Snowden, PhD University of the West of Scotland
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jenny Young, Mrs Jenny Young, University of the West of Scotland
ClinicalTrials.gov Identifier: NCT02274701    
Other Study ID Numbers: 14/WS/0126
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Neoplasms