Interactive Decision Aid for Men Diagnosed With Prostate Cancer

Reykjavik University

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Decision Aid for Men with Localized Prostate Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04260737

141490-052 (Other Grant/Funding Number)

VSN-18-127

Details and patient eligibility

About

Prostate cancer is the second leading cause of cancer related deaths in the western world (National Cancer Institute, 2011). Prostate cancer diagnosis relates to significant psychological distress (Roesch et al, 2005; Hervouet et al, 2005). The management options available for men with localized prostate cancer typically offer similar survival rate and one treatment has not been determined more effective than other. Variance in severity, duration and frequency of side effects between treatments is considerable (National Cancer Institute, 2011). This can make the choice between management options challenging and distressing. Researches show that patients that are actively involved and provided with sufficient information have better health outcomes (Stewart, 1995).

The study involves implementing interactive, web-based decision-aid to assist men with localized prostate cancer with their decision regarding their prostate cancer management options. Participants will be randomized to standard-care (SC) and SC + interactive decision-aid (IDA). The SC group will meet with their urologist and receive and information brochure. In addition the IDA group will receive a website that includes a wealth of information (e.g., overview about prostate cancer, overview of different treatment options, pros and cons of different treatment options and a value clarification exercise that is designed to assist participants to weigh the risks and benefits of each prostate cancer management option).

The effectiveness of the intervention will be evaluated with questionnaires administered prior to randomization (baseline) and then again two weeks, one, three and six months after the randomization.

Aim 1. Evaluate the relative impact of SC versus SC + IDA on medical decision making. It is hypothesized that participants randomized to the SC + IDA arms will have improved decision making (e.g., reduced decisional conflict) and psychosocial outcomes (e.g., distress), compared to those randomized to SC only.

Aim 2. Identify mechanisms by which the interventions impact patient outcomes. It is hypothesized that: 1) improved decision making and psychosocial outcomes for the IDA arms will be mediated by increased knowledge; 2) participants who are undecided about the treatment decision and those that have information-seeking decision styles will benefit most from the decision-aid interventions.

Enrollment: 163 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed with localized prostate cancer.

Exclusion criteria

• Reads and understands Icelandic
• Can give informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Standard Care

No Intervention group

Description:

The control group will receive standard care for localized prostate cancer, i.e., information from their doctor and an information brochure.

Decision Aid + Standard Care

Experimental group

Description:

The intervention group will receive standard care and intervention that includes a website with the Decision Aid which covers the following: 1. An overview about prostate cancer; 2. An overview of different treatment options (e.g. surgery and active surveillance) 3. The pros and cons of different treatment options (e.g., physical, emotional, social). 4. A value clarification exercise that is designed to assist participants to weigh the pros and cons of each prostate cancer management option.

Treatment:

Other: Decision Aid for Men with Localized Prostate Cancer