Skip to content

Evaluation of the usefulness of a decision aid in patients with advanced colorectal or breast cancer

When the treatment goal is not cure: A randomised controlled trial of enhanced patient achievement of information and involvement preferences and more active involvement in treatment decision-making following the use of decision aids in patients with advanced colorectal or breast cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000084482
Enrollment
210
Registered
2007-01-24
Start date
2003-03-18
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

We have developed two user-friendly decision aids (DAs) for patients with incurable breast or bowel cancer. These include an instrument used by doctor and patient in the consultation, and a take-home booklet and audiotape for patients. The DAs outline treatment options, benefits and likely side effects. Information is presented in different visual formats. This should help patients participate in their cancer treatment decisions. Patients and doctors have reviewed the DAs, and their usefulness will now be tested in a randomised trial. Hypotheses being examined in this study (in the randomised trial): Patients receiving DAs at the time of making a treatment decision about management of advanced cancer compared to patients not receiving DAs at this time will have enhanced achievement of their involvement preference, participate in decision-making more actively and have improved understanding of their prognosis, treatment goals and side effects, as well as be more satisfied with their care. Doctors using the DAs in consultations will have enhanced satisfaction with treatment decision-making. This project is also being run in Toronto, Canada. The recruitment target of 210 includes 105 from Canada. Recruitment is complete in all sites and analysis is underway.

Interventions

Use of a decision aid during the consultation by the medical oncologist and provision of the decision aid and audiotape for patient to take home. The decision aid contains information on potential managment decisions, risks and benefits of treatment options, side effects, treatment regimes, survival statistics, pros and cons of choices. The duration of use of the DA in the consultation is not set, it may be used as long as is required. The audiotapes is a recording of the content of the booklet.

Use of a decision aid during the consultation by the medical oncologist and provision of the decision aid and audiotape for patient to take home. The decision aid contains information on potential managment decisions, risks and benefits of treatment options, side effects, treatment regimes, survival statistics, pros and cons of choices. The duration of use of the DA in the consultation is not set, it may be used as long as is required. The audiotapes is a recording of the content of the booklet. Participants may listen or read the decision aid as often as they wish and the DA and audiotape are theirs to keep. Consultation length is as long as required.

Sponsors

Medical Psychology Research Unit, University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Inclusion: patients newly diagnosed with metastatic colorectal or breast cancer.

Exclusion criteria

Exclusion: insufficient English, spoken and comprehension, current psychiatric diagnosis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026