Interactive Decision Aid for Men Diagnosed With Prostate Cancer

NCT04260737 | Completed

• 2 other identifiers: VSN-18-127141490-052
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Localized Prostate Cancer; Decision Aid; Medical Decision Making

Outcome Measures

Primary Outcomes (8)

• Change in decisional conflict over time

  The Decisional Conflict Scale (DCS) is a measure that was designed to evaluate health-care-consumer decisions. It is a 16-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on DCS range from 0 to 100, were higher score indicate greater decisional conflict. It has test-retest reliability of 0.81 and internal consistency ranges from α=.0.78 to 0.92.

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

• Change in decisional regret over time

  The Decision Regret Scale (DRS) measures regret after health care decision. It is a 5-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on DRS range from 0 to 100, were higher score indicate more regret after health care decision. It has good internal consistency that ranges from α=.0.81 to 0.92.

  2 weeks, 1 month, 3 months and 6 months.

• Change in satisfaction with decision over time

  The Satisfaction with Decision Scale (SWDS) measures satisfaction with health care decision. It is a 5-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on SWDS range from 5 to 25, were higher score indicate more satisfaction with a decision.The scale has good internal consistency (α=.0.86).

  2 weeks, 1 month, 3 months and 6 months.

• Change in anxiety over time

  The Generalized Anxiety Disorder - 7 (GAD-7) is a 7-item measure used to screen for general anxiety disorder and to measure its severity. It is also a good screening tool for social anxiety disorder, panic disorder and post traumatic stress disorder. Response options range from "not at all" to "several days" on a 4-point Likert scale. GAD-7 total score ranges from 0 to 21, were higher score indicates more severe anxiety. It has excellent internal consistency (α = 0.92).

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

• Change in depression over time

  The Patient Health Questionnaire (PHQ-9) is a widely used and well validated measure used to screen for depression and assess severity of it. It is a 9-item scale and answers are on 4-point Likert scale ranging from "not at all" to "nearly every day". PHQ-9 total score ranges from 0 to 27, were higher score indicates more severe depression. PHQ-9 has been shown to be a reliable and valid measure.

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

• Change in Stress over time

  The Perceived Stress Scale (PSS-10) is a 10-item scale used to measure stress. Each item on the list is rated on a five point Likert scale ranging from "never" to "very often". PSS-10 total score ranges from 0 to 40, were higher score indicates higher perceived stress. The PSS has adequate reliability and validity.

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

• Change in Stress over time

  The NCCN Distress Thermometer and checklist is a widely used screening measure for distress in cancer patients. It consists of a distress thermometer where participants assess their distress on a scale from 0 to 10, were 0 indicates no distress and 10 extreme distress. Additionally participants answer a problem checklist with several domains to identify what area of life distresses the participant.

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

• Change in Cancer related Stress over time

  The Impact of events scale-revised (IES-R) is a widely used questionnaire that measures trauma related stress, that is cancer specific distress. It is a 22-item measure that includes three factors; avoidance, hyper arousal and intrusion. Those factors together form a cancer-specific distress measure and the higher the score on the scale suggest more distress. Total score range from 0 to 88. The IES-R has high internal consistency and test-retest reliability ranges from 0.51-0.94.

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

Secondary Outcomes (4)

• Control preference

  Baseline

• Localized Prostate cancer knowledge

  Baseline, 2 weeks, 1 month, 3 months and 6 months.

• Health Information Orientation

  Baseline

• Intolerance of uncertainty

  Baseline

Study Arms (2)

Standard Care

NO INTERVENTION

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

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.

Other: Decision Aid for Men with Localized Prostate Cancer

Interventions

Decision Aid for Men with Localized Prostate Cancer OTHER

The intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options.

Decision Aid + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only those that have been assigned the biological sex of male at birth are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with localized prostate cancer.

You may not qualify if:

• Reads and understands Icelandic
• Can give informed consent

Sponsors & Collaborators

• Reykjavik University: lead
• The Icelandic Research Fund: collaborator
• The Icelandic Cancer Society: collaborator

Study Sites (1)

Reykjavik University

Reykjavik, 102, Iceland

Location

Related Publications (4)

• 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.

  PMID: 16015462 BACKGROUND

• 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.

  PMID: 16310621 BACKGROUND

• Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.

  PMID: 7728691 BACKGROUND

• 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.

  PMID: 29614997 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Decision Support Techniques; Menogaril

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Heiddis B Valdimarsdottir, PhD

  Reykjavik University

  PRINCIPAL INVESTIGATOR

• Birna Baldursdottir, PhD

  Reykjavik University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: February 7, 2020
• Study Start: February 26, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)