Evaluation of the Palliative Care Needs Assessment Intervention
| ISRCTN | ISRCTN21699701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21699701 |
| Secondary identifying numbers | Cancer Trials NSW PC-11-01 |
- Submission date
- 13/05/2009
- Registration date
- 29/05/2009
- Last edited
- 18/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Afaf Girgis
Scientific
Scientific
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
| Phone | +61 (0)2 4913 8600 |
|---|---|
| afaf.girgis@newcastle.edu.au |
Study information
| Study design | Multicentre interventional interrupted time series design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of the Palliative Care Needs Assessment Intervention: a multicentre interrupted time series design |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 660 patients and 396 caregivers |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Aruba
- Australia
Study participating centre
Centre for Health Research and Psycho-oncology (CHeRP)
Callaghan
2308
Aruba
2308
Aruba
Sponsor information
Australian Government Department of Health and Ageing (Australia)
Government
Government
GPO Box 9848
Canberra
2601
Australia
| Phone | +61 (0)2 6289 1555 |
|---|---|
| jane.hanson@health.gov.au | |
| Website | http://www.health.gov.au/ |
"ROR" |
https://ror.org/0314h5y94 |
Funders
Funder type
Government
Australian Government Department of Health and Ageing (Australia)
No information available
National Health and Medical Research Council (NHMRC) (Australia) - PhD scholarship (ref: 455644)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 11/01/2010 | Yes | No |
Editorial Notes
18/12/20017: publication reference added.
