A pilot study to determine the feasibility and acceptability of a non-pharmacological intervention to prevent delirium for people with advanced cancer in hospital.

Not Applicable

Completed

• Conditions: Delirium; Advanced cancer; Neurological - Other neurological disorders; Cancer - Any cancer

• Registration Number: ACTRN12617001070325
• Lead Sponsor: The Palliative Care Clinical Studies Collaborative (PaCCSC)

Brief Summary

We developed a non-pharmacological delirium prevention intervention and pilot tested it with 65 patients with advanced cancer in four palliative care units. Two palliative care units immediately delivered the intervention, two units delivered it after a ‘control’ period, and all units regularly assessed patients for delirium. The main measure was how often patients received its six domains (eating and drinking, sleep, exercise, reorientation, vision and hearing, and family partnership). We decided that if at least 60% patients fully received the intervention that it would not need to be changed in a larger trial. We also measured how often delirium occurred; how severe it was; whether the intervention caused any harm; and asked 39 people what they thought about it in brief interviews. The two units that first delivered the intervention did so fully for 5% patients (partially for 25%). The units that delivered it later did so fully for 25% patients (partially for 45%). Delirium occurred within one week of admission for 32% of patients in control units and 20% of intervention unit patients. There was no difference in delirium severity. The intervention did not cause harm. The interviews informed how to simplify the intervention and involve family caregivers and volunteers. The main conclusion was that a larger trial will be feasible and acceptable with a modified intervention.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Study Completion: 2018-09-28
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Sites will be Australian oncology or palliative care inpatient units that provide inpatient care for people with advanced cancer. Data will be collected for all admitted patients aged 18 years or older with a diagnosis of advanced cancer.

2. Patients who received the intervention, speak English or have availability of a health care interpreter, able to give fully informed written consent and participate in a brief semi-structured interview, will be eligible to participate in a qualitative sub-study.

3. Family caregivers of patients who received the intervention, aged 18 years or older, able to speak English or have a health care interpreter available, able to give fully informed written consent and participate in a brief semi-structured interview will be eligible to participate in a qualitative sub-study.

4. Any clinician or manager employed at an intervention site and involved in implementing the intervention and/or delirium measures will be eligible to participate in a survey.

5. Site volunteers aged 18 years or older, enrolled in a formal volunteer program at an intervention site and involved in implementing the intervention will be eligible to participate in a survey.

Exclusion Criteria

1. Data will not be collected for patients under 18 years of age or without a diagnosis of advanced cancer.

2. Patients who do not receive the intervention, or with an Australian Karnofsky Performance Status (AKPS) score less than 30 and/or are in the terminal phase will be excluded from the qualitative sub-study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to the intervention, measured as completed domains according to data collected from patient medical records via case report form.[During the first seven days of admission.]