Clinical trial NCT04260737: Interactive Decision Aid for Men Diagnosed With Prostate Cancer
Official title: Developing and Testing an Interactive Decision Aid for Newly Diagnosed Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Localized Prostate Cancer
Decision Aid
Medical Decision Making
Lead sponsor: Reykjavik University
Sponsor class: OTHER
Collaborators: name: The Icelandic Research Fund
name: The Icelandic Cancer Society
First posted: 2020-02-07
Enrollment: 163
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with localized prostate cancer.

Exclusion Criteria:

* Reads and understands Icelandic
* Can give informed consent

Primary outcomes:
measure: Change in decisional conflict over time
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
measure: Change in decisional regret over time
timeFrame: 2 weeks, 1 month, 3 months and 6 months.
measure: Change in satisfaction with decision over time
timeFrame: 2 weeks, 1 month, 3 months and 6 months.
measure: Change in anxiety over time
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
measure: Change in depression over time
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
measure: Change in Stress over time
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
measure: Change in Stress over time
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
measure: Change in Cancer related Stress over time
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Secondary outcomes:
measure: Control preference
timeFrame: Baseline
measure: Localized Prostate cancer knowledge
timeFrame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
measure: Health Information Orientation
timeFrame: Baseline
measure: Intolerance of uncertainty
timeFrame: Baseline
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Reykjavik University
Study officials:
affiliation: Reykjavik University
name: Heiddis B Valdimarsdottir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Reykjavik University
name: Birna Baldursdottir, PhD
role: STUDY_DIRECTOR
References:
citation: Roesch SC, Adams L, Hines A, Palmores A, Vyas P, Tran C, Pekin S, Vaughn AA. Coping with prostate cancer: a meta-analytic review. J Behav Med. 2005 Jun;28(3):281-93. doi: 10.1007/s10865-005-4664-z.
citation: Hervouet S, Savard J, Simard S, Ivers H, Laverdiere J, Vigneault E, Fradet Y, Lacombe L. Psychological functioning associated with prostate cancer: cross-sectional comparison of patients treated with radiotherapy, brachytherapy, or surgery. J Pain Symptom Manage. 2005 Nov;30(5):474-84. doi: 10.1016/j.jpainsymman.2005.05.011.
citation: Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
citation: Berger O, Gronberg BH, Loge JH, Kaasa S, Sand K. Cancer patients' knowledge about their disease and treatment before, during and after treatment: a prospective, longitudinal study. BMC Cancer. 2018 Apr 3;18(1):381. doi: 10.1186/s12885-018-4164-5.