Implementation of a nurse-led self-management support intervention for patients with cancer-related pain: a cluster randomized phase-IV study with a stepped wedge design (EvANtiPain).

BACKGROUND: Pain self-management support interventions were effective in controlled clinical trials and meta analyses. However, implementation of these complex interventions may not translate into identical effects. This paper evaluates the implementation of ANtiPain, a cancer pain self-management support intervention in routine clinical practice according to the Reach Efficacy-Adoption Implementation Maintenance framework. METHODS: In this cluster randomized study with a stepped wedge design, N = 153 adult patients with cancer-related pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria. ANtiPain entailed a face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies, information on pain self-management, and skills building. After discharge, cancer-pain self-management was coached via phone calls. Patient-level data were collected at recruitment, and 2, 4 and 8 weeks after discharge via postal or online questionnaire. Primary outcome was pain interference with daily activities. Secondary outcomes included pain intensity, self-efficacy, and patient satisfaction. Organizational-level data (e.g., on implementation procedures) were collected by study or intervention nurses. The mixed model to analyze patient-level data included a random intercept and a random slope for individual and a random intercept for ward. RESULTS: Recruitment was slower than expected and unevenly distributed over wards and hospitals. The face-to-face session was clinically feasible (mean duration = 33 min) as well as the mean amount (n = 2) and duration of phone calls (mean = 17 min). Only 16 (46%) of 35 trained nurses performed the intervention on nine wards. To deal with the loss of power, analyses were adapted. Overall effects on pain interference were not significant. However, effects were significant in sub analyses of the nine wards that recruited patients in the intervention period (p = .009). Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy (p = .033), and patient satisfaction with information on pain-self-management (p = .002) and in-hospital pain management (p = .018). CONCLUSIONS: The implementation of ANtiPain improved meaningful patient outcomes on wards that applied the intervention routinely. Our analyses showed that the implementation benefited from being embedded in larger scale projects to improve cancer pain management and that the selection of wards with a high percentage of oncology patients may be crucial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02891785 Date of registration: September 8, 2016.

Effects of Written Information and Counseling on Illness-Related Uncertainty in Women With Vulvar Neoplasia.

OBJECTIVES: To determine whether written information and/or counseling decreases illness-related uncertainty in women with vulvar neoplasia. SAMPLE & SETTING: 49 women with vulvar neoplasia from four Swiss hospitals and one Austrian hospital. METHODS & VARIABLES: A longitudinal, multicenter, randomized phase 2 study was performed. The written information group received a set of leaflets. The counseling group received five consultations with an advanced practice nurse (APN) from diagnosis to six months postsurgery that focused on symptom self-management, healthcare services, and decision making. Uncertainty was measured as a secondary outcome five times by the Mishel Uncertainty in Illness Scale. RESULTS: Total uncertainty and the subscales of ambiguity, inconsistency, and unpredictability improved significantly over time within the counseling group but not within the written information group. In addition, counseling improved inconsistency over time, and total uncertainty, inconsistency, and unpredictability at distinct time points more efficiently than written information. IMPLICATIONS FOR NURSING: Counseling can reduce illness-related uncertainty. APNs are valuable healthcare providers who promote women's self-management and may support them in becoming more familiar with illness-related events and common symptoms during this rare disease.

Effectiveness, structure, and content of nurse counseling in gynecologic oncology: a systematic review.

BACKGROUND: Gynecological pre-cancer and gynecological cancers are considerable diseases in women throughout the world. The disease and treatment lead to numerous biopsychosocial issues. To improve the outcomes of affected women, several counseling interventions have been tested thus far in nursing research. These interventions target different endpoints and are composed of various structural and content components. The purpose of this research was to systematically review the effectiveness of nurse counseling on any patient outcomes tested so far in gynecologic oncology before, during and after treatment and to explore structure and content components. METHODS: Experimental, quasi-experimental, and pre-experimental studies assessing the effectiveness of nurse counseling in women with gynecological neoplasia were searched for in PubMed®, CINAHL®, PsychINFO®, Cochrane®, and EMBASE®. Reference lists were hand-searched and relevant authors were contacted. Moreover, the evidence level and methodological quality of the included studies were assessed. Afterwards, the effect of nurse counseling on each identified patient outcome was narratively analyzed. To identify the structural and content components of the included interventions, a structured content analysis was performed. Finally, it was determined which components were associated with favorable outcomes within the included studies. RESULTS: Seven experimental and three pre-experimental studies, reporting the effects of 11 interventions on a total of 588 participants, were eligible. No study investigated women with pre-cancer. Three studies had a high, five a moderate, and two a low methodological quality. Positive effects were found on quality of life, symptoms, and healthcare utilization. Eight structural components and four content components composed of various sub-components were identified and linked to specific effects. CONCLUSIONS: The current evidence base is fragmented and inconsistent. More well-designed, large-scale studies including women with pre-cancer are warranted. Most convincing evidence indicates that nurse counseling can improve symptom distress. Components associated with the most trustworthy effects include nurses with an academic education; repeated and individual consultations during and after active treatment; structured, tailored, interdisciplinary orientated, and theoretically based counseling concepts; specific materials; comprehensive symptom management; and utilization of healthcare services. Healthcare providers and researchers can use the findings of this review for the systematic development of nurse counseling in gynecologic oncology.

The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study.

OBJECTIVE: To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. METHODS: A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written information received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. RESULTS: A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporadically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. CONCLUSIONS: The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial.

Recommendations for symptom management in women with vulvar neoplasms after surgical treatment: An evidence-based guideline.

PURPOSE: To develop an evidence-based guideline for nurses and other health care professionals involved in pre- and postsurgical care of women with vulvar cancer (VC) or vulvar intraepithelial neoplasia (VIN). METHODS: This evidence-based guideline was developed according to six domains of the methodological framework AGREE II. Literature research with focus on cancer care, symptom management and self-management/counselling was conducted from April to August 2013 in the databases CINAHL, Cochrane Library, PsycINFO, PubMed as well as in 14 international guideline databases. Interdisciplinary experts (n = 14) were involved in the development of the guideline from December 2013 to January 2014. This guideline is currently tested in the WOMAN-PRO II RCT (Clinical Trial No: NCT01986725). RESULTS: For the definition of recommendations, five guidelines, one meta-analysis, two systematic reviews and two randomized controlled trials were included. In total, 24 recommendations were formulated to answer 22 clinical questions based on patients' perspective and experts' opinion. Evidence ranged from 3.5 to 5 (3.5 = weak evidence and/or clinical relevance, 5 = best evidence and/or clinical relevance). The recommendations were subsumed under different themes regarding physical, psychological and psychosocial aspects. CONCLUSIONS: The clinical practice guideline developed in this study firstly provides recommendations for symptom management issues focusing on self-management interventions for women with VC or VIN. As an interdisciplinary guideline it should be used in addition to the existing medical guideline in the German speaking context.