Evidence map›Paper›PMID 27576298›Full record

Trial reportBMC cancer2016

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

Kaina Zhou, Duolao Wang, Xiaole He, Lanting Huo, Jinghua An, Minjie Li, Wen Wang, Xiaomei Li

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Kaina ZhouXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
Duolao WangLiverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK.
Xiaole HeXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
Lanting HuoXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
Jinghua AnXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
Minjie LiXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
Wen WangXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
Xiaomei LiXi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China. roselee@mail.xjtu.edu.cn.
Xi'an Jiaotong University · CNLiverpool School of Tropical Medicine · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBreast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer.

methodsThis is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. DISCUSSION: This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer.

trial registrationChictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

Indexed as

Quality of LifeAsian PeopleBreast NeoplasmsFemaleHealth Knowledge, Attitudes, PracticeHumansResearch DesignSingle-Blind MethodBreast cancerCluster randomized controlled trialHealth belief modelHealth-related quality of lifeMultimodal standard nursing programStudy protocol

Identifiers

PMID27576298
PMCPMC5006518
OpenAlexW2513495339

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.