Evaluating the usefulness of a decision aid in cancer care

This is a randomised controlled study looking at the benefits of the use of a decision aid with metastatic colorectal or breast cancer patients in terms of enhanced achievement of their involvement preference in treatment decision-making and their cancer care, as well as enhanced understanding of treatment options, goals, benefits and side effects.  A systematic review of decision aids has recently shown that decision aids increase understanding, reduce decisional conflict and do not increase anxiety.  However, few decision aids have been evaluated in the cancer context, and none with patients with metastatic disease.  This is the first study in this patient population.  Recruitment to this study is complete, with 209 newly diagnosed advanced colorectal cancer patients at 5 cancer centres in Australia and Canada randomized to receive either a standard medical oncology consultation, or the same plus the DA, (take-home booklet with audio-recording, selected review by oncologist).  Final analysis of the data is underway and results are to be presented at two conferences in 2007; the American Society of Clinical Oncology (ASCO), Chicago, USA, and the International Shared Decision Making Conference, Freiburg, Germany.

Funding: The Cancer Council, NSW


Improving informed consent: A randomised controlled trial of a decision aid for women invited to participate in IBIS-II

This study aims to evaluate the effectiveness of a novel intervention within a clinical trial setting, a decision aid (DA), to assist women in reaching an informed decision about participation in a breast cancer prevention trial (IBIS-II). The IBIS-II clinical trial evaluates the role of anastrozole (hormonal treatment) in the management of post-menopausal women who are at increased risk of breast cancer. Women receiving the DA are expected to have a better understanding of treatment options and clinical trials, reduced decisional conflict, enhanced achievement of information needs, greater satisfaction with care and no greater anxiety. The decision aid may also improve recruiter satisfaction with the consent process; and prove a successful strategy for reducing drop-out from clinical trials. The current study has the potential to transform the process of gaining informed consent in large multi-centre trials.

Funding: The Susan G KOMEN Breast Cancer Foundation (USA)


A decision aid for patients with locally advanced rectal cancer deciding on adjuvant therapy

This study aims to pilot a decision aid for patients with locally advanced rectal cancer and is being carried out in collaboration with the Surgical Outcomes Research Centre, Central Sydney Area Health Service and the University of Sydney . There is controversy amongst the medical community regarding the benefits and costs of adjuvant therapy, and this is a difficult decision for patients and clinicians to make. This computerized decision aid is designed for use in the surgical consultation and is supplemented by a booklet for patients to take home. Preliminary pilot data in a community sample of people participating in the Rotary Bowel Screening program indicated that the decision aid was acceptable and valued. It is currently being piloted in a clinical sample with eight participating surgeons.

Funding: EHA


Decision aid for women with ovarian cancer deciding on treatment options after they have elevated Ca-125 levels

This is a colloborative study being conducted in the Department of Gynae-Oncology at the Royal Prince Alfred Hospital. Following a complete clinical response to initial therapy, a rise of CA-125 is thought to be the first sign of cancer relapse in about 70% of women. Many patients remain asymptomatic for extended periods of time despite exhibiting very high CA-125 levels. The knowledge that someone has rising CA-125 levels, yet remains clinically asymptomatic presents a major management dilemma for doctors and patients, as there is no clear evidence that beginning a second-line treatment (of either chemotherapy or Tamoxifen) on the basis on raising CA-125 levels alone is of any survival or quality of life benefit. This is further compounded by the possible toxicity from such a treatment when patients would otherwise be asymptomatic. For the woman, the news of rising CA-125 levels is known to trigger feelings of panic, profound fear and devastation that the cancer has reoccurred. It is at this time that a woman is asked to make a decision concerning her second-line treatment. This project aims to develop and evaluate the usefulness of, a decision aid (DA) in reducing decisional conflict and psychological distress whilst increasing knowledge about treatment options and satisfaction with the decision-making process in ovarian cancer patients considering second-line treatment following an asymptomatic increase of their CA-125 tumour marker. The DA may also improve clinicians’ satisfaction with the decision-making process.

Funding: Sydney Cancer Centre Foundation Research Grant