Journal Article

The effects of an integrated supportive care intervention on quality of life outcomes in outpatients with breast and gynecologic cancer undergoing chemotherapy: Results from a randomized controlled trial

Klafke, Nadja, Schneeweiss, Andreas, Mueller, Andreas, Szecsenyi, Joachim, Mahler, Cornelia, Bentner, Martina, Hagens, Cornelia, Uhlmann, Lorenz, Joos, Stefanie

2019

Overview

The aim of the Complementary Nursing in Gynecologic Oncology study was to investigate the effects of a complex, nurse‐led, supportive care intervention using Complementary and Integrative Medicine (CIM) on patients’ quality of life (QoL) and associated patient‐reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynecologic cancer undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of CIM applications and counseling for symptom management, as well as CIM information material. The primary endpoint was global QoL measured with the EORTC‐QLQ‐C30 before and after CHT. Mixed linear models considering fixed and random factors were used to analyze the data. In total, 126 patients were randomly assigned into the IG and 125 patients into the CG (median age 51 years). The patients’ medical and socio‐demographic characteristics were homogenous at baseline and at follow‐up. No group effects on QoL were found upon completion of CHT (estimate −1.04 [−4.89; 2.81]; P = 0.596), but there was a significant group difference in favor of the IG 6 months later (estimate 6.643 [1.65; 11.64]; P = 0.010). IG patients did also experience significant better emotional functioning (P = 0.007) and less fatigue (P = 0.027). The tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self‐management competencies. During and after chemotherapy (CHT), patients report high levels of symptoms, in particular fatigue, pain, nausea/vomiting, or distress, strongly affecting their quality of life (QoL). To cope with such burden, patients report high usage of complementary therapies (CIM), however, the evidence of CIM supportive programs is scarce. The results of the Complementary Nursing in Gynecologic Oncology‐study indicate that CIM interventions administered regularly from the beginning of CHT treatment, have potential to improve patients’ QoL, but the effects need time to develop, and can only be clearly demonstrated 6 months after completion of CHT.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: Abdomen / Aged / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Breast / Breast cancer / Breast Neoplasms - diagnosis / Breast Neoplasms - epidemiology / Breast Neoplasms - therapy / Cancer therapies / Chemotherapy / Clinical Cancer Research / Clinical trials / Complementary Therapies / Counseling / Data analysis / Data collection / Delivery of Health Care / Fatigue / Female / Genital Neoplasms, Female - diagnosis / Genital Neoplasms, Female - epidemiology / Genital Neoplasms, Female - therapy / Germany - epidemiology / gynecologic cancer / health services research / Humans / Immunoglobulins / Integrative Oncology - methods / Intervention / Middle Aged / Nurses / Nursing / nursing intervention / Oncology / Original Research / Outpatients / Patient Reported Outcome Measures / Patients / patient‐reported outcomes / Quality of Life / Randomized Controlled Trials as Topic / self‐care / Studies / supportive care / Surveys and Questionnaires / Symptom management