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
Identifieur interne : 001148 ( Main/Exploration ); précédent : 001147; suivant : 001149Effectiveness 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
Auteurs : Kaina Zhou ; Duolao Wang ; Xiaole He ; Lanting Huo ; Jinghua An ; Minjie Li ; Wen Wang ; Xiaomei LiSource :
- BMC Cancer [ 1471-2407 ] ; 2016.
Abstract
Breast 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.
This 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.
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.
Chictr.org.cn
Url:
DOI: 10.1186/s12885-016-2726-y
PubMed: 27576298
PubMed Central: 5006518
Affiliations:
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Kaina" uniqKey="Zhou K" first="Kaina" last="Zhou">Kaina Zhou</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author><author><name sortKey="Wang, Duolao" sort="Wang, Duolao" uniqKey="Wang D" first="Duolao" last="Wang">Duolao Wang</name><affiliation><nlm:aff id="Aff2">Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA UK</nlm:aff><wicri:noCountry code="subfield">L3 5QA UK</wicri:noCountry></affiliation></author><author><name sortKey="He, Xiaole" sort="He, Xiaole" uniqKey="He X" first="Xiaole" last="He">Xiaole He</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author><author><name sortKey="Huo, Lanting" sort="Huo, Lanting" uniqKey="Huo L" first="Lanting" last="Huo">Lanting Huo</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author><author><name sortKey="An, Jinghua" sort="An, Jinghua" uniqKey="An J" first="Jinghua" last="An">Jinghua An</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author><author><name sortKey="Li, Minjie" sort="Li, Minjie" uniqKey="Li M" first="Minjie" last="Li">Minjie Li</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author><author><name sortKey="Wang, Wen" sort="Wang, Wen" uniqKey="Wang W" first="Wen" last="Wang">Wen Wang</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author><author><name sortKey="Li, Xiaomei" sort="Li, Xiaomei" uniqKey="Li X" first="Xiaomei" last="Li">Xiaomei Li</name><affiliation><nlm:aff id="Aff1">Xi’an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi’an, Shaanxi 710061 China</nlm:aff><wicri:noCountry code="subfield">Shaanxi 710061 China</wicri:noCountry></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Breast 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.</p></sec><sec><title>Methods</title><p>This 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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>Chictr.org.cn <ext-link ext-link-type="uri" xlink:href="http://www.chictr.org.cn/showprojen.aspx?proj=13952">ChiCTR-IOR-16008253</ext-link> (April 9, 2016)</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Torre, La" uniqKey="Torre L">LA Torre</name></author><author><name sortKey="Bray, F" uniqKey="Bray F">F Bray</name></author><author><name sortKey="Siegel, Rl" uniqKey="Siegel R">RL Siegel</name></author><author><name sortKey="Ferlay, J" uniqKey="Ferlay J">J Ferlay</name></author><author><name sortKey="Lortet Tieulent, J" uniqKey="Lortet Tieulent J">J Lortet-Tieulent</name></author><author><name sortKey="Jemal, A" uniqKey="Jemal A">A 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uniqKey="Wang W" first="Wen" last="Wang">Wen Wang</name><name sortKey="Zhou, Kaina" sort="Zhou, Kaina" uniqKey="Zhou K" first="Kaina" last="Zhou">Kaina Zhou</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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