Evaluation of the Palliative Care Needs Assessment Intervention

Evaluation of the Palliative Care Needs Assessment Intervention: a multicentre interrupted time series design

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21699701

Enrollment

660

Registered

2009-05-29

Start date

2006-11-01

Completion date

Unknown

Last updated

2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced cancer Cancer Advanced cancer

Interventions

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, a

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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 base	—

Measure

Time frame

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 base

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Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026