Study Purpose
To determine if decision-making support (called decision navigation) was feasible, acceptable, and effective among patients newly diagnosed with prostate cancer with the aim of evaluating confidence in making treatment decisions, certainty in decisions made, and changes in mood and adjustment
Intervention Characteristics/Basic Study Process
Decision navigation involved two primary components, a list of questions to support the question and answer process and audio recordings and summaries to improve information recall.
Sample Characteristics
-
N = 113
-
MEAN AGE = 67.2 years (control), 65.4 years (intervention
-
MALES: 100%
-
KEY DISEASE CHARACTERISTICS: Inclusion criteria were early-stage, newly diagnosed primary prostate cancer, pending cancer management decision, and referral to a urology specialist for consultation.
-
OTHER KEY SAMPLE CHARACTERISTICS: All participants were Caucasian males. There were no significant differences between the control and intervention group.
Setting
-
SITE: Single site
-
SETTING TYPE: Outpatient
-
LOCATION: Western General Hospital in Edinburgh, Scotland
Phase of Care and Clinical Applications
-
PHASE OF CARE: Diagnostic
-
APPLICATIONS: Elder care
Study Design
Randomized, controlled trial
Measurement Instruments/Methods
Seven instruments were used:
-
Baseline demographics survey for age, education, employment, living arrangements, and ethnicity
-
Decisional Self-Efficacy (DSE) is an 11-item scale that measures confidence in decisions. It was administered at baseline, after the consultation planning appointment, after the consultation, and after six months.
-
Decisional Conflict Scale (DCS) is a measure of certainty about decisions. It was administered after the consultation and after six months.
-
Decision regret (RS) was measured at six months.
-
Mental Adjustment to Cancer Scale (MAC) has subscales that measure fighting spirit or hopelessness-helplessness, anxiety, and fatalism. It was administered at baseline and six months after consultation.
-
Hospital Anxiety and Depression Scale (HADS) was administered at baseline and six months after the consultation.
-
Decision Preparation Measure (DPM), a five-item rating scale, was administered after the consultation planning appointment and after six months to evaluate the use of the intervention and to confirm final treatment choice.
Results
DSE scores were significantly (p = 0.011) higher for the intervention group after the consultation and at six months. Intervention group DSE scores showed significant (p = 0.008) improvement at six months postconsultation.
DCS scores were significantly (p = 0.047) lower in the intervention group after consultation, and approached significance after six months. DR scores were significantly (p = 0.36) lower in the intervention group.
DN significantly increased the confidence of the intervention group in making treatment decisions and for certainty about the right decision. When tested after six months, DN intervention patients reported continued confidence and certainty about the decisions made (approaching a significant effect), and showed significantly (p = 0.036) less regret about decisions after six months. There was no impact on anxiety, depression, or mental adjustment to cancer. Participants had low baseline scores for depression, anxiety, and mental adjustment to cancer. DN evaluation ratings indicated that consultation planning assisted \"a great deal\" or \"quite a bit.\"
Conclusions
The intervention was not shown to have an impact on anxiety or depression symptom scores.
Limitations
-
Risk of bias (no blinding)
-
Findings not generalizable
-
Intervention expensive, impractical, or training needs
-
Subject withdrawals ≥ 10%
-
Other limitations/explanation: Although the sample size was 113 participants, only 53 were in the control group and 62 were in the intervention group (less than 100 in each group), limiting this study's generalizability. There are training needs regarding the specific and individualized list of questions provided in anticipation of the consultation. It is possible that the physicians could become accustomed to the questions on the list, therefore increasing the amount of information given to the patient without interaction? Ninety-nine patients refused to participate in the study, and 10 patients withdrew.
Nursing Implications
Dedicated decision support for patients preparing for treatment consultation involves patients, increases confidence in asking questions during the consultation, and increases certainty about decisions made. Research to evaluate the effectiveness and cost reduction potential of DN for people with other cancer diagnoses is important. Although decision support interventions are essential to assist patients in decision making, these approaches alone may not be sufficient to manage symptoms of depression and anxiety.
Print