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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the West of Scotland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Macmillan Cancer Support

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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