Clinical trial NCT02274701: Holistic Needs Assessment in Outpatient Cancer Care
Official title: Evaluating the Impact of Holistic Needs Assessment in Outpatient Cancer Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oncology [See Also, Affected System]
Lead sponsor: University of the West of Scotland
Sponsor class: OTHER
Collaborators: name: Macmillan Cancer Support
First posted: 2014-10-24
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

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

Primary outcomes:
measure: Patient participation
timeFrame: 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:
measure: Shared decision making
timeFrame: 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.
measure: Self-efficacy
timeFrame: 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..
Other outcomes:
Locations:
Study officials:
affiliation: University of the West of Scotland
name: Austyn Snowden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.