None listed
Conditions
Brief summary
The purpose of this study is to investigate the efficacy of a decision aid (DA) for women with asymptomatic ovarian cancer and rising CA-125 levels after successful first-line treatment. Participants will be randomised to receive either the DA or a control booklet called "Understanding Ovarian Cancer”. All participants will complete an initial questionnaire when they first make their treatment decision, and a follow-up questionnaire 4 months later. It is anticipated that the DA will improve understanding of the treatment options, reduce decisional conflict, increase satisfaction with decision-making, and not increase anxiety, compared to the control booklet.
Interventions
Women with asymptomatic ovarian cancer and rising CA-125 levels will be randomised to receive either a Decision Aid (intervention group) or a Cancer Council NSW booklet called Understanding Ovarian Cancer (control group). The Decision Aid is a booklet containing clear written and graphical information about each of the main treatment options, as well as exercises to help with the process of weighing up the pros and cons of these options. Participation in the study involves filling out two questi
Women with asymptomatic ovarian cancer and rising CA-125 levels will be randomised to receive either a Decision Aid (intervention group) or a Cancer Council NSW booklet called Understanding Ovarian Cancer (control group). The Decision Aid is a booklet containing clear written and graphical information about each of the main treatment options, as well as exercises to help with the process of weighing up the pros and cons of these options. Participation in the study involves filling out two questionnaires over a 4 month period. The study is expected to conclude in 2012.
Sponsors
Centre for Medical Psychology and Evidence-based Decision-making
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Women with a diagnosis of epithelial ovarian cancer, who have undergone tumour debulking / cyto-reductive surgery, have completed first-line chemotherapy, and are currently asymptomatic during follow-up with rising CA-125 levels.
Exclusion criteria
Women who do not understand sufficient English to read the booklet and complete the questionnaires, have a concurrent psychiatric disorder or are cognitively impaired are not eligible for the study.
Outcome results
None listed