Cancer Pain Self-management Clinical Trial
Official title:
Evaluation of the Project "Improvement of Nurse-led Self-management Support for Patients With Cancer-related Pain": An Accompanying Cluster Randomized Study With a Stepped Wedge Design
Background: Significant barriers to cancer pain management are patient-related. So far,
cancer pain self-management support interventions have only been tested in strictly
controlled settings of randomized controlled trials (RCT) and thus evidence for comparative
effectiveness is lacking.
Methods: This study includes a multicenter cluster RCT with a stepped wedge design and a
qualitative substudy. The aim of the study is to evaluate the implementation of ANtiPain in
clinical practice. The primary patient-related aim is to improve pain interference with daily
activities. Secondary patient-related aims are pain intensity, barriers to pain management,
self-efficacy, and quality of life. Secondary organization-related aims are nurse proficiency
and satisfaction with cancer pain self-management support, participation rates, and
implementation fidelity.
Inclusion and exclusion criteria: On 17 wards in 3 hospitals in Vienna adult oncology
patients will be included (n=150 pre-, n=150 post-implementation) if they are admitted to one
of the participating wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular
pain medication, able to understand German, discharged with pain self-management, and give
informed consent. Patients with signs of disorientation that may severely limit pain
self-management will be excluded.
Interventions: Pre-implementation, patients receive standard care. Post-implementation,
patients receive ANtiPain which is based on 3 key strategies: information, skills building
and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone
calls after discharge. The implementation process will include training of the designated
staff nurses, case discussions, as well as measures to ensure sustainability of the
implementation (e.g., training of clinical nurse specialists).
Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete
questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be
collected before implementation and 1 and 3 months after implementation. Data on ward and
hospital level will be collected at the beginning of the study.
Statistical analysis: The statistical analysis will be conducted based on mixed models, with
a random intercept for the respective ward and time as a covariate.
Qualitative substudy: The qualitative substudy will comprise interviews with head and
intervention nurses about their views of the implementation.
Background Despite highly effective treatment options, adequate pain control is a persistent
problem in oncology patients. As cancer treatment is shifted increasingly towards the
outpatient setting, patients' self-management is vital for successful pain treatment.
ANtiPain (Advanced Nursing Practice cancer pain self-management support) is a cancer pain
self-management support intervention for patients with cancer that is already available and
tested in a German speaking setting. So far, cancer pain self-management support
interventions have only been tested in the rigorously controlled setting of a randomized
controlled trial (RCT) and thus evidence for its comparative effectiveness is lacking.
Objective This study is unique in that it aims to evaluate the implementation of the ANtiPain
intervention in routine clinical practice in view of its effectiveness for patients and
nurses in realistic clinical settings.
Methods Design, setting and sample In the context of routine quality improvement, AntiPain
will be implemented on designated wards at three hospitals in Vienna. To evaluate the
implementation, an accompanying multicenter cluster randomized trial with a stepped wedge
design will be supplemented with embedded qualitative evaluations. The stepped wedge design
will involve the sequential rollout of the intervention. The order in which ANtiPain will be
implemented on the wards will be determined at random. By the end of the study, all wards
will have implemented the intervention.
Patients will be recruited on 17 wards. With an effect size of d=.77 and an expected drop-out
rate of 20%, a sample size of 150 patients will be needed before and after implementation to
demonstrate a difference at the 5% level with 90% power. With 17 wards and a study duration
of 15 months, approximately 1.3 patients will be recruited per month on each of the
participating wards.
Objective and specific aims In congruence with the Reach Efficacy Adoption Implementation and
Maintenance (RE-AIM) framework, the implementation of ANtiPain will be evaluated on two
levels: (i) patient-related outcomes (e.g., pain interference with daily activities, pain
intensity, patient related barriers to cancer pain management), and (ii) organization-related
outcomes (e.g., nurses' self-rated perceived proficiency with pain management, application
fidelity).
The primary aim of this implementation project is to improve patient-related outcomes. The
primary patient-related outcome will be pain interference with daily activities. Secondary
patient-related outcomes will be pain intensity, patient-related barriers to cancer pain
management, pain-related self-efficacy, and quality of life. The secondary aim is to explore
the participation rate [Reach], to improve nurse-related outcomes [e.g. proficiency and
satisfaction concerning pain self-management support (Adoption and Implementation)], to
achieve high implementation fidelity in the clinical setting [Implementation], to evaluate
the nursing managers' view on the implementation [Adoption], a crude cost and resource
estimation of the implementation [Adoption], to explore how implementation fidelity will
develop over time [Maintenance], and to explore the nursing managers views on maintaining the
intervention in their organization [Maintenance]).
Implementation of cancer pain self-management support Before the implementation, patients
receive standard care without structured cancer pain self-management support. After
implementation, patients will receive cancer pain self-management support by trained staff
nurses who follow the ANtiPain protocol. ANtiPain is based on three key strategies: Provision
of information, skills building and nurse coaching. It consists of an in-hospital baseline
one-to-one session before discharge and a telephone follow up according to a structured
clinical algorithm that is based on pain intensity, patient satisfaction with pain management
and patient adherence. The implementation process will include training of the designated
staff nurses, coaching activities based on case discussions on the ward, as well as measures
to ensure sustainability of the implementation (e.g., training of ward managers and clinical
nurse specialists).
Variables and Measurement Data collection on patient level will include pain interference
with daily activities, pain intensity, and analgesic intake from the Brief Pain Inventory. In
addition, the self-developed item from a previous study will be used to measure pain-related
activity hindrance, by asking patients to rate "The pain hindered me to do things that I
wanted to do today" on a 0 (not at all) to 10 (completely) numeric rating scale.
Patient-related barriers to cancer pain management will be measured with the German short
version of the Barriers Questionnaire II (BQII-G-S); pain-related self-efficacy with the
German version of the Pain Self-efficacy Questionnaire (FESS); HRQoL with two items from the
EORTC-Quality of Life Questionnaire C30, functional status with the German version of the
Eastern Cooperative Oncology Group Performance Status (ECOG-PS); Depression with the Patient
Health Questionnaire (PHQ-2); demographic and clinical data will include age, gender, time
since first cancer diagnosis, time since first pain onset, circadian rhythm of pain, and
analgesic medication, reason for and day of hospitalization as well as the day of discharge.
Full patient self-report data collection will include ~80 items. Because patient burden was a
substantial issue in our last studies, patients who say that they cannot complete all
questionnaires will be offered to complete a short version of the study questionnaires (49
items).
Data collection on nurse level will include 4 questions regarding self-rated proficiency with
cancer pain self-management support and satisfaction with pain management on the ward. In
addition, demographic data will be obtained (e.g., age, time on ward). Data collection on
ward and hospital level will include the medical field, length of stay, and the number of
patients (with cancer-related pain). Standard care will be explored by asking nurses about
their role in cancer pain self-management support before the implementation.
Qualitative substudy: The qualitative substudy will comprise interviews with head nurses and
intervention nurses about their views of the implementation.
Procedures Wards will be randomized according to the stepped wedge plan. Data collection will
start January 2016. Eligible patients will be recruited by staff nurses who will be supported
by a study assistant. After informed consent patients will be asked to complete
questionnaires at admission (TP0), as well as 2 (TP1), 4 (TP2) and 8 weeks (TP3) after
discharge. Nurse-level data will be collected one week before implementation (TN0) and 1
(TN1) and 3 months after implementation (TN2). Data on ward and hospital level will be
collected by a study assistant at the beginning of the study.
The statistical analysis of the primary outcome (i.e., pain interference with daily
activities) will be conducted based on mixed models, with a random intercept for the
respective ward and time as a covariate to take potential time trends into account.
Ethical considerations The study will be conducted in accordance with the Declaration of
Helsinki. Within the clusters (wards), patients will be provided with tailored oral and
written informed consent (i.e., pre- and post-implementation). During the informed consent
procedure patients will be informed about the quality improvement project in general. As soon
as the intervention has been implemented in routine clinical practice on the respective ward,
patients will be offered the intervention. Consequently, the informed consent procedure will
not involve consent for the intervention but only for the completion of questionnaires.
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