Holistic Needs Assessment in Outpatient Cancer Care

October 24, 2014 updated by: Jenny Young, University of the West of Scotland

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / 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 Names:
  • The Concerns Checklist
No Intervention: Control
The control group entails standard care - routine consultation between the patient and clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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..
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..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the West of Scotland

Collaborators

Macmillan Cancer Support

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 24, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/WS/0126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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