Background: Most individuals affected by cancer who are treated with certain chemotherapies suffer of CIPN. Therefore, there is a high patient and provider interest in complementary non-pharmacological therapies, but its evidence base has not yet been clearly pointed out in the context of CIPN. Methods: The results of a scoping review overviewing the published clinical evidence on the application of complementary therapies for improving the complex CIPN symptomatology are synthesized with the recommendations of an expert consensus process aiming to draw attention to supportive strategies for CIPN. The scoping review, registered at PROSPERO 2020 (CRD 42020165851), followed the PRISMA-ScR and JBI guidelines. Relevant studies published in Pubmed/MEDLINE, PsycINFO, PEDro, Cochrane CENTRAL, and CINAHL between 2000 and 2021 were included. CASP was used to evaluate the methodologic quality of the studies. Results: Seventy-five studies with mixed study quality met the inclusion criteria. Manipulative therapies (including massage, reflexology, therapeutic touch), rhythmical embrocations, movement and mind–body therapies, acupuncture/acupressure, and TENS/Scrambler therapy were the most frequently analyzed in research and may be effective treatment options for CIPN. The expert panel approved 17 supportive interventions, most of them were phytotherapeutic interventions including external applications and cryotherapy, hydrotherapy, and tactile stimulation. More than two-thirds of the consented interventions were rated with moderate to high perceived clinical effectiveness in therapeutic use. Conclusions: The evidence of both the review and the expert panel supports a variety of complementary procedures regarding the supportive treatment of CIPN; however, the application on patients should be individually weighed in each case. Based on this meta-synthesis, interprofessional healthcare teams may open up a dialogue with patients interested in non-pharmacological treatment options to tailor complementary counselling and treatments to their needs.
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.
Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy. CONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants’ HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients. Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes. German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).
1 December 2016 in Complementary Therapies in Medicine