Evaluating the feasibility, acceptability and potential effectiveness of complex nursing intervention focused on quality of life assessment on advanced cancer patients with palliative care needs

A phase II quasi-experimental trial evaluating the feasibility, acceptability and potential effectiveness of complex nursing intervention focused on quality of life assessment on advanced cancer patients with palliative care needs

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41201864

Enrollment

Registered

2016-09-26

Start date

2015-12-07

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Palliative care (advanced stage cancer patients) Cancer

Interventions

This is a multicentre two-stage study. The study will be conducted on a convenience sample of two hospice units of the urban district of Genoa in the North of Italy: the Gigi Ghirotti Bolzaneto Hospic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All the PC team members within the two hospices during the modeling and feasibility phase 2. Adult patients (aged >=18 years) newly admitted to hospice units during the 6-month period of the feasibility phase (pre-test= 3 months; post-test= 3 months)

Exclusion criteria

Exclusion criteria: 1. Patients too ill to receive the intervention 2. Unable to give informed consent either due to cognitive impairment or because they are unable to understand Italian

Design outcomes

Primary

Measure	Time frame
Patient QoL (potential effectiveness) assessed using the Italian version of the Palliative Outcome Scale (POS) before (period I: 3 months) and after (period II: 3 months) the intervention	—

Secondary

Measure	Time frame
1. Patient management, evaluated using an adapted version of the composite patient management score by Detmar et al. (2002). All QoL-related management actions taken by staff for patients are calculated by summarizing all the actions taken. Data is collected from medical and nursing charts and ad hoc documentation, which comprises the terminology included in the QoL tool (i.e., the POS) to collect actions delivered to patients for each of impaired QoL dimensions resulting from the POS score. 2. Acceptability of the study, evaluated in terms of number of patients accepting to participate in this study. 2.1. Acceptability of the intervention from the patients’ perspective. Once the delivery of the intervention is completed, acceptability is examined using an ad hoc semi-structured questionnaire. Patients are asked to appraise the intervention in terms of appropriateness and usefulness in collecting their own needs using a QoL tool and to suggest ways to enhance its acceptability and to identify any missing elements (Sidani & Braden, 2011). 2.2. Acceptability of the intervention from the staff’s perspective. Acceptability is assessed using an ad hoc semi-structured interview including five open questions. After implementing the intervention – at the end of a 3-month period – staff members’ acceptability is explored in terms of relevance, appropriateness and usefulness in addressing QoL of palliative care patients. To enhance the completeness and acceptability of the intervention, staff members are asked to suggest ways to modify any aspects of the intervention and their professional views on maintaining the INFO-QoL as a standard for the unit. Preliminary to staff interviews, a fundamental overview of QoL as main focus of palliative care, the intervention (i.e. the INFO-QoL) is provided, and then staff are asked to answer the following questions: 1. How would you comment on the relevance of the intervention in addressing palliative care patients’ QoL? 2. How would y	—

Measure

Time frame

1. Patient management, evaluated using an adapted version of the composite patient management score by Detmar et al. (2002). All QoL-related management actions taken by staff for patients are calculated by summarizing all the actions taken. Data is collected from medical and nursing charts and ad hoc documentation, which comprises the terminology included in the QoL tool (i.e., the POS) to collect actions delivered to patients for each of impaired QoL dimensions resulting from the POS score. 2. Acceptability of the study, evaluated in terms of number of patients accepting to participate in this study. 2.1. Acceptability of the intervention from the patients’ perspective. Once the delivery of the intervention is completed, acceptability is examined using an ad hoc semi-structured questionnaire. Patients are asked to appraise the intervention in terms of appropriateness and usefulness in collecting their own needs using a QoL tool and to suggest ways to enhance its acceptability and to identify any missing elements (Sidani & Braden, 2011). 2.2. Acceptability of the intervention from the staff’s perspective. Acceptability is assessed using an ad hoc semi-structured interview including five open questions. After implementing the intervention – at the end of a 3-month period – staff members’ acceptability is explored in terms of relevance, appropriateness and usefulness in addressing QoL of palliative care patients. To enhance the completeness and acceptability of the intervention, staff members are asked to suggest ways to modify any aspects of the intervention and their professional views on maintaining the INFO-QoL as a standard for the unit. Preliminary to staff interviews, a fundamental overview of QoL as main focus of palliative care, the intervention (i.e. the INFO-QoL) is provided, and then staff are asked to answer the following questions: 1. How would you comment on the relevance of the intervention in addressing palliative care patients’ QoL? 2. How would y

—

Countries

Italy

Contacts

Public ContactGianluca Catania

gianluca.catania@edu.unige.it+39 (0)10 353 8589

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026