Patient Empowerment Improved Perioperative Quality of Care in Cancer Patients Aged ≥ 65 Years - A Randomized Controlled Trial

Abstract

Purpose: This randomized controlled, clinical prospective interventional trial was aimed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients.

Methods: This trial was performed from February 2011 to January 2014 at two tertiary medical centers in Germany. The study included patients aged 65 years and older undergoing elective surgery for gastro-intestinal, genitourinary, and thoracic cancer. The patients were randomly assigned to the intervention group, i.e. patient empowerment through information booklet and diary keeping, or to the control group, which received standard care. Randomization was done by block randomization in blocks of four in order of enrollment. The primary outcome were 1,postoperative length of hospital stay (LOS) and 2. long-term global health-related quality of life (HRQoL) one year postoperatively. HRQoL was assessed using the EORTC QLQ C30 questionnaire. Secondary outcomes encompassed postoperative stress and complications. Further objectives were the identification of predictors of LOS, and HRQoL at 12 months.

Results: Overall 652 patients were included. The mean age was 72 ± 4.9 years, and the majority of patients were male (68.6%, n = 447). The ^median of postoperative length of stay was 9 days (IQR 7-14 day). There were no significant differences between the intervention and the control groups in postoperative LOS (p = 0.99) or global HRQoL after one year (women: p = 0.54, men: p = 0.94). While overall complications and major complications occurred in 74% and 24% of the cases, respectively, frequency and severity of complications did not differ significantly between the groups. Patients in the intervention group reported significantly less postoperative pain (p = 0.03) than the control group. Independent predictors for LOS were identified as severity of surgery, length of anesthesia, major postoperative complications, nutritional state, and pre-operative physical functional capacity measured by the Timed Up and Go-test by multiple robust regressions.

Conclusion: Patient empowerment through information booklet and diary keeping did not shorten the postoperative LOS in elderly onco-surgical patients, but improved quality of care regarding postoperative pain. Postoperative length of stay is influenced by pre-operative nutritional state, pre-operative functional impairment, severity of surgery, and length of anesthesia.

Trial registration: Clinicaltrials.gov. Identifier NCT01278537.

Conflict of interest statement

Competing Interests: The authors have the following interests: SoStAna GmbH is owned by Prof. Dr KD Wernecke. The authors charged the external statistician Prof. Dr. KD Wernecke with the sample size calculation for the study protocol. MS, VvD received parts of their salary from the Deutsche Krebshilfe (grant DKH- 108474). MS received payment for lecture from Dahlhausen in 2014. RE, KS, BN, JS, CST and KDW have declared that no competing interests exist. CDS applied and received fundings from the Deutsche Krebshilfe (German Cancer Aid; DKH-108474) for outside payments please see the attached icjme form for disclosure of potential conflicts of interest. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Fig 1. Study flow diagram.

Fig 2. Median postoperative length of in-hospital stay.

(A) The median length of postoperative in-hospital stay was 9 (IQR 7) days in the intervention group and 9 (IQR 9) days in the control group (p = 0.99).

Fig 3. Health-related global quality of life after 12 months for intervention and control groups.

HRQoL 12 months after surgery was comparable in intervention and control groups (all patients p = 0.74).

Fig 4. Course of HRQoL.

Comparing the baseline and follow-up values for health-related quality of life only for patients who survived and answered the 12 months questionnaire (n = 418), there were neither clinical relevant nor statistical significant differences between baseline and 12 months for HRQoL (intervention women: p = 0.58; men: p = 0.49; control women: p = 0.16; men = 0.29). Compared to age and gender-adjusted reference values for the German population [18], men showed better global health-related quality of life than the reference population with clinical relevance. In contrast, women quoted a lower score of global HRQoL but without clinical relevance.

Fig 5. Perioperative complications.

Overall complications occurred in 74% of the patients. There was no difference between intervention and control group (p = 0.79). Major (Clavien Grade III and higher) perioperative complications occurred in 24% of the patients. There was no difference between the groups (p = 0.41).

Fig 6. Mortality within 30 days and within one year after surgery for intervention and control groups (p = 0.75 and p = 0.19 respectively).

Within 30 days after surgery, 4 patients in the intervention and 3 patients in the control group had died (p = 0.75). One year after surgery, 45 patients in the intervention group compared to 58 patients in the control group had died (p = 0.19).

Fig 7. Kaplan Meier Estimation of Survival in intervention and control groups.

Patients were followed up to one year after surgery. After 12 months 103 (15.8%) patients had died. Mortality did not differ between intervention and control groups (log rank p = 0.197).