Dataset Information

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials.

ABSTRACT:

Objective

The participation of patients with advanced cancer(s) in clinical trials is vital for new drug development. We aimed to investigate patients' decision-making processes and satisfaction with their decision (SWD) to participate; the study's purpose was to provide results that can help support high-quality research in clinical trials. In addition, we explored how shared decision-making (SDM) mediates the relationship between understanding informed consent forms and SWD to participate in a clinical trial.

Methods

A cross-sectional study was conducted. A purposive sample of 111 cancer patients was recruited, and they completed a questionnaire on demographic characteristics, SDM, and decision-making satisfaction to participate in a clinical trial. Correlation and mediation analyses were used.

Results

Participants aged under 65 years and with higher education reported high SWDs, and SDM significantly mediated the relationship between self-assessed understanding of informed consent forms and SWDs related to clinical trials.

Conclusions

SDM in patients with lung or liver cancer was a significant mediator between understanding the informed consent form and the patient's SWD. The higher the SWD level of participating in clinical trials, the better study team members' SDM involvement and the better the comprehension of informed consent forms. In addition, patients' age and education level should also be considered as influencing factors in SWD. This survey is the first in Taiwan to examine SDM in drug-related clinical trials. The study results provide evidence to support SDM in a clinical trial model and develop informed consent process policies in research facilities.

SUBMITTER: Chang WW

PROVIDER: S-EPMC10372169 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials.

Chang Wen-Wen WW Wu Ming-Tzu MT Chang Yun-Chen YC Hu Wen-Yu WY

Asia-Pacific journal of oncology nursing 20230623 8

<h4>Objective</h4>The participation of patients with advanced cancer(s) in clinical trials is vital for new drug development. We aimed to investigate patients' decision-making processes and satisfaction with their decision (SWD) to participate; the study's purpose was to provide results that can help support high-quality research in clinical trials. In addition, we explored how shared decision-making (SDM) mediates the relationship between understanding informed consent forms and SWD to particip ...[more]

PMID: 37519403

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Project description:BackgroundStrabismus is a complex disease that has various treatment approaches each with its own advantages and drawbacks. In this context, shared decisions making (SDM) is a communication process with the provider sharing all the relevant treatment alternatives, all the benefits, and risks of each procedure, while the patient shares all the preferences and values regarding his/her choices. In that way, SDM is a bidirectional process that goes beyond the typical informed consent. Therefore, it is known a little of the extent to which SDM influences the satisfaction with the treatment outcome along with strabismus patients. To study this correlation, an SDM-Q-9 questionnaire was provided within surgical consultations where treatment decisions were made; the SDM-Q-9 aims to assess the relationship between the post-operative patient's satisfaction and their SMD score.MethodsThe study is considered a prospective observational pilot study. Eligible patients were adult patients diagnosed with strabismus, who had multiple treatment options, were given at the right of choice without being driven into a physician's preference. Ninety-three strabismus patients were asked to fill out the SDM-Q-9 questionnaire related to their perception of SDM during the entire period of strabismus treatment. After the treatment, patients were asked to rate their satisfaction level with the surgical outcome as excellent, good, fair, and poor. Descriptive statistics and the linear regression statistical tests (Spearman, Mann Whitney U, and Kriskal-Wallis) were used as analysis tools.ResultsThe average age of the participants was 24, where 50.6% were women. The mean SDM-Q-9 score among patients was 32 (IQR = 3). The postoperative patient satisfaction was rated as being excellent by 16 (17.2%) patients, good by 38 (40.9%), fair by 32 (34.4%), and poor by 7 patients (7.5%). Data analysis by linear regression statistical tests showed a positive correlation between the SDM-Q-9 score and the patient satisfaction related to the surgery outcome (B = 0.005, p < 0.001). Criteria in assessing patients' satisfaction were age, gender, and strabismus type. A positive correlation between SDM and real satisfaction (r = 0.834, p < 0.01) was found with age, and no significant relationship was found while taking into consideration the responder's gender and the strabismus type.ConclusionsAssessing patient satisfaction after choosing a treatment for strabismus method helped us evaluate the gaps in constructive dialogue that would lead to a positive outcome for both patient and clinician. The correlation between the SDM process and the patients' satisfaction with surgery outcome, adjusted by age, has been established. These findings can serve as a springboard to further communicative improvements related to the SDM process and between patients and physicians, thereby consequently leading to patients' satisfaction raise in strabismus care. The study underlines the importance of further analysis and validation of on-ground interactions among the adolescent and adult patients and the clinicians across the strabismus management trajectory. A multicentral study and its validation will follow.

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Dataset Information

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials.

Objective

Methods

Results

Conclusions

Publications

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials.

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