Assessing the Feasibility of a Self-Management Intervention for Individuals With Advanced Prostate Cancer and Comorbid Type II Diabetes Mellitus.
This pilot study suggests that a self-management intervention for prostate cancer patients with diabetes is feasible and may improve diabetes management, but further research is needed.
Where it sits
this study against the rest of the goserelin corpusSummary and findings
This pilot study evaluated a self-management intervention for men with advanced prostate cancer and type II diabetes mellitus. Participants were randomized to receive individualized pharmacy and nutrition education or to a non-interventional group. The intervention was feasible with over 75% engagement and resulted in improved diabetes knowledge and decreased HbA1c levels.
Abstract
<h4>Background</h4>Many older adults with cancer have at least one comorbidity. Type II diabetes mellitus (T2DM) is a common comorbidity among patients with prostate cancer (PC) and represents an important consideration in this population. Comorbid T2DM can negatively impact cancer-specific outcomes for patients, suggesting the need for better glycemic management, especially for patients on active cancer treatment. The goal of this modified Diabetes Self-Management Education Services (mDSMES) pilot study was to provide patients with the opportunity to learn methods of diabetes self-management, including how to manage their glucose levels, improve their understanding and utilization of medication to promote improvements in health, and optimize PC treatment outcomes.<h4>Methods</h4>Men with comorbid T2DM and advanced-stage PC receiving androgen deprivation therapy were recruited from the cancer center and randomized to an individualized pharmacy and nutrition education and counseling intervention or a non-interventional observational group. Diabetes knowledge was assessed with a validated tool. Feasibility and acceptability were assessed through adherence and questionnaire. Laboratory assessments included serum HbA1c measurement.<h4>Results</h4>Among the 803 screened, 177 had T2DM, 50 were eligible, and 28 were consented and randomized. 22 men completed the study. Results show feasibility with > 75% engagement and an average acceptability questionnaire score of 37.3/56. Knowledge test scores increased among mDSMES intervention participants, and HbA1c decreased in all participants, with a continuing trend in mDSMES intervention participants not seen in SOC participants.<h4>Conclusion</h4>The pilot clinical trial was feasible and acceptable, and participants gained insight and were effectively educated about T2DM self-care. A positive residual effect on HbA1c was indicated. Next steps involve refining the intervention based on provider and participant feedback and expanding it to a larger segment of the comorbid T2DM-PC population.
Background
Prostate cancer patients often have comorbid conditions like type II diabetes mellitus, which can negatively impact cancer-specific outcomes. Effective glycemic management is crucial for these patients, especially those undergoing cancer treatment. This study addresses the need for improved diabetes self-management to potentially enhance treatment outcomes for prostate cancer patients with diabetes.
Methods
The study was a pilot randomized controlled trial involving men with advanced prostate cancer and type II diabetes mellitus. Participants were recruited from a cancer center and randomized to either an individualized pharmacy and nutrition education intervention or a non-interventional observational group. The primary outcomes were feasibility and acceptability, assessed through engagement and questionnaire scores, while secondary outcomes included diabetes knowledge and HbA1c levels.
Results
Out of 803 screened, 177 had type II diabetes, 50 were eligible, and 28 were randomized. The intervention demonstrated feasibility with over 75% engagement and an average acceptability score of 37.3 out of 56. Participants in the intervention group showed increased diabetes knowledge and a reduction in HbA1c levels, with a continuing trend not observed in the standard of care group.
Interpretation
The intervention appears to be feasible and acceptable, with potential benefits in diabetes management for prostate cancer patients. However, the small sample size and pilot nature limit the ability to draw definitive conclusions about clinical efficacy. Further research with larger samples is needed to confirm these findings and assess long-term clinical outcomes.
Key findings
- 803 screened, 177 had T2DM, 50 eligible, 28 consented and randomized.
- 22 men completed the study.
- > 75% engagement in the intervention.
- Average acceptability questionnaire score of 37.3/56.
- HbA1c decreased in all participants, with a trend continuing in mDSMES group.
Limitations
- small n=28 pilot
- short follow-up
- single-site study
- pilot nature limits generalizability