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Advance care planning (ACP) in incurable cancer patients with disease progression on first line chemotherapy: a randomised trial

A randomised control trial to evaluate the effect of a formal advance care planning (ACP) intervention compared to standard practice on the documentation of patient wishes, compliance with known end of life (EOL) wishes and the quality of death of patients with progressive incurable cancer on first line chemotherapy.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001288718
Enrollment
668
Registered
2013-11-21
Start date
2014-02-19
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This project aims to evaluate the effect of a formal advance care planning intervention (ACP) on the documentation of patient wishes, compliance with known end of life (EOL) wishes and the quality of death of patients with progressive incurable cancer on first line chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with an incurable cancer with disease progression on first line chemotherapy. Eligible patients must be able to nominate a family member or friend who is willing to participate in the study who is 18 years of age or over. Study details Patients and their family/friend/carer will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard end of life care. Participants in the other group will receive standard care plus a formal advance care planning intervention. All patients and family who request information on life expectancy will be provided with typical, best case and worst case scenarios for survival time. The intervention aims to promote discussion between patient and family and the health care team and to promote documentation of the patient’s preferences for continuing and EOL care. The intervention involves the patient plus a family member or friend meeting with a specially trained nurse to have conversations about their goals, wishes and needs for care now and in the future, as well as how these matters will be shared with their doctor and health care team. For those patients allocated to the group who receive the intervention, this program will take between half an hour to 3 hours over 1 to 3 visits to complete, depending on patient preference. Patients will be asked to complete some questionnaires at baseline, 6 weeks, and every 3 months thereafter to evaluate quality of life and satisfaction with care. The patient’s family/friend/carer will also be asked to complete some questionnaires at baseline, 6 weeks, every 3 months until the patient’s death, and then at 3 months after bereavement to evaluate their perceived quality of death and the impact of death on surviving family. The costs of care will also be assessed.

Interventions

Advance Care Planning (ACP) refers to the process by which patients, families and health professionals (HPs) discuss and establish future goals of care in accordance with the patient’s values and preferences. ACP provides a formal means of informing health professionals and family of the patient’s wishes. If patients become too ill to make decisions, documentation of their preferences regarding End of Life (EOL) care will enable patients to receive the care they would have chosen. Moreover, A

Advance Care Planning (ACP) refers to the process by which patients, families and health professionals (HPs) discuss and establish future goals of care in accordance with the patient’s values and preferences. ACP provides a formal means of informing health professionals and family of the patient’s wishes. If patients become too ill to make decisions, documentation of their preferences regarding End of Life (EOL) care will enable patients to receive the care they would have chosen. Moreover, ACP can relieve the burden of decision-making for family members. ACP is patient-centred in that it promotes shared-decision-making, supports substitute decision-making where appropriate and aims to achieve good EOL care. For this trial ACP will be administered in a face to face meeting by a specially trained nurse. The session will take between half an hour to 3 hours over 1 to 3 visits to complete, depending on patient preferences.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of an incurable cancer with disease progression on first line chemotherapy and an expected median survival of less than 12 months. Able to nominate one (only) family member or friend who is willing to participate in the study 18 years of age or over Able to read and write English Able and well enough to read a booklet and complete some questionnaires (e.g. can’t be confused)

Exclusion criteria

Previous formal advance care planning

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026