Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Afaf Girgis
ORCID ID
Contact details
Centre for Health Research and Psycho-oncology (CHeRP)
Cancer Council NSW and University of Newcastle
Room 230A
Level 2
David Maddison Building
Callaghan
2308
Aruba
+61 (0)2 4913 8600
afaf.girgis@newcastle.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Cancer Trials NSW PC-11-01
Study information
Scientific title
Evaluation of the Palliative Care Needs Assessment Intervention: a multicentre interrupted time series design
Acronym
Study hypothesis
The systematic use of the Palliative Care Needs Assessment Guidelines and Needs Assessment Tool: Progressive Disease-Cancer (NAT: PD-C) will result in a better match between unmet needs and service utilisation of people with advanced cancer and their caregivers.
Ethics approval
1. University of Newcastle Human Research Ethics Committee approved on the 13th December 2006 (ref: H-355-1206)
2. Hunter New England Area Health Service Human Research Ethics Committee approved on the 19th October 2006 (ref: 06/09/27/4.01)
3. Sydney South West Area Health Service Human Research Ethics Committee approved on the 13th March 2007 (ref: 2007/05)
4. South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee (Central Network) approved on the 13th December 2006 (ref: 06/113 Girgis)
Study design
Multicentre interventional interrupted time series design
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced cancer
Intervention
Patient and caregiver participants will complete computer assisted telephone interviews (CATIs) every two months for a period of up to two years. Interviews will include questions about unmet needs, anxiety and depression, quality of life, satisfaction with care and service utilisation. The introduction of the intervention will begin approximately six months after the commencement of recruitment. The intervention will involve the introduction of the Guidelines and NAT: PD-C to medical, nursing and allied health professionals at each of the recruitment sites. Health professionals will be trained in the use of the Guidelines and NAT: PD-C and will be asked to complete the tool on each patient during their usual appointments (approximately monthly). Participants will continue completing CATIs every two months during the post-intervention phase of the study. Changes in outcomes will be compared pre- and post-intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Each patient's unmet need as measured by the Supportive Care Needs Survey Short Form (SCNS-SF34). Each of the 34 items are mapped to five different domains: physical and daily living, psychological, patient care and support, health system and information and sexuality. Each domain is standardised to a score out of 100. Changes in domain scores will be measured at 2-monthly intervals from baseline for up to 15 months. Six spirituality items from the Needs Assessment for Advanced Cancer Patients (NA-ACP) will also be included to assess changes in spirituality needs. The sample size will give the study the power to detect a difference of between 4.2 and 6.7 units in each of the domains.
2. Each caregiver's unmet need as measured by the Supportive Care Needs Survey Partners and Caregivers (SCNS-PC). Changes in domain scores will be measured at 2-monthly intervals from baseline for up to 15 months. The study will be able to detect a difference of between 5.3 and 8.6 units in each of the SCNS domains for caregivers.
3. Patient self-report service utilisation, in particular the number of health professionals seen in the month preceding the patient's interview. Changes will be measured at 2-monthly intervals from baseline for up to 15 months.
Secondary outcome measures
1. Patient anxiety and depression as measured by the Hospital and Anxiety Depression Scale (HADS). A score out of 21 is obtained for each subscale, classifying people as normal (score 0 - 7), borderline (score 8 - 10) or clinically anxious or depressed (score 11 - 21). Changes in subscale scores will be measured at 2-monthly intervals from baseline for up to 15 months. The study will be able to detect a difference of between 1 and 0.7 units in anxiety and depression scores.
2. Caregiver anxiety and depression as measured by the HADS. A score out of 21 is obtained for each subscale, classifying people as normal (score 0 - 7), borderline (score 8 - 10) or clinically anxious or depressed (score 11 - 21). Changes in subscale scores will be measured at 2-monthly intervals from baseline for up to 15 months. The study will be able to detect a difference between 1.2 and 1.5 in anxiety and depression scores.
3. Patient quality of life as measured by the two global questions from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30). The scores for the two items will be added together and averaged and then scaled out of 100, with a higher score indicating a greater quality of life. Changes in score will be measured at 2-monthly intervals from baseline for up to 15 months. The study will be able to detect a difference of 4.7 units.
4. Caregiver quality of life as measured by the two global questions from the EORTC QLQ C30. The scores for the two items will be added together and averaged and then scaled out of 100, with a higher score indicating a greater quality of life. Changes in score will be measured at 2-monthly intervals from baseline for up to 15 months. The study will be able to detect a difference of 4.7 units.
5. Caregiver satisfaction with care as measured by the Family Satisfaction with Advanced Cancer Care Scale (FAMCARE). Changes in score will be measured at 2-monthly intervals from baseline for up to 15 months. The study will be able to detect a difference of 3.4 units.
Overall trial start date
01/11/2006
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patient criteria:
1. Person with a diagnosis of advanced cancer, i.e., no longer amenable to cure, with either extensive local or regional spread or metastatic disease
2. Aged 18 years or older, either sex
3. Able to understand English sufficiently to complete questionnaires and telephone interviews
Caregiver criteria:
1. The primary carer or the family member who provided, or may provide when needed, the most help to the patient, as nominated by the patient
2. Able to understand English sufficiently to complete questionnaires and telephone interviews
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
660 patients and 396 caregivers
Participant exclusion criteria
Patients criteria:
1. Cognitively unable to give consent or unable to understand and respond to questions in English
2. Younger than 18 years of age
Caregiver criteria:
1. Cognitively unable to give consent or unable to understand and respond to questions in English
Recruitment start date
01/11/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Health Research and Psycho-oncology (CHeRP)
Callaghan
2308
Aruba
Sponsor information
Organisation
Australian Government Department of Health and Ageing (Australia)
Sponsor details
GPO Box 9848
Canberra
2601
Australia
+61 (0)2 6289 1555
jane.hanson@health.gov.au
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Australian Government Department of Health and Ageing (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Health and Medical Research Council (NHMRC) (Australia) - PhD scholarship (ref: 455644)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Protocol on: https://www.ncbi.nlm.nih.gov/pubmed/20150987