Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial

Abstract Background Head and neck cancer (HNC) patients are at high risk for developing lymphedema and fibrosis (LEF) following cancer treatment. Once HNC patients develop LEF, they need to conduct life-long self-care to slow LEF progression and reduce associated symptom burden and functional deficits. Data demonstrate that inadequate LEF self-care may be a potentially remediable issue. The objective of this study is to explore the feasibility and preliminary efficacy of an Information-Motivation-Behavioral (IMB) Skills model-driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments. Methods/design This is a three-arm, prospective, randomized controlled clinical trial to compare: Group 1 – Usual Care, Group 2 – Usual Care Plus LEF-SCP, and Group 3 – Usual Care Plus LEF-SCP Plus Follow-Up. Participants will be HNC survivors aged > 18 years of age, who meet predefined inclusion and exclusion criteria. A sample size of 75 participants is targeted. Interventions will be provided by trained staff. The study assessments for all groups will take place at five points: study entry then 3, 6, 9, and 12 months post enrollment. Outcome measures include: (1) feasibility (barriers to implementation, safety, and satisfaction) of the proposed intervention; (2) self-efficacy and adherence to self-care; and (3) preliminary efficacy (LEF progression, symptom burden, and functional status) of the proposed intervention. Discussion This will be the first study to evaluate the feasibility of a LEF-SCP in the HNC population and its impact on self-efficacy and adherence. Furthermore, it will evaluate the potential benefit of routine follow-up on adherence and fidelity to the self-care protocol. We expect that the trial will provide evidence supporting the feasibility of a LEF self-care program. In addition, we anticipate that preliminary data will support improved outcomes including increased adherence and fidelity, and decreased LEF-associated symptoms. Trial registration ClinicalTrials.gov, a service of the US National Institute of Health (NCT 03030859). Registered on 22 January 2017.

Tags
Data and Resources
To access the resources you must log in

This item has no data

Identity

Description: The Identity category includes attributes that support the identification of the resource.

Field Value
PID https://www.doi.org/10.6084/m9.figshare.c.4799424
PID https://www.doi.org/10.6084/m9.figshare.c.4799424.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4799424.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4799424
Access Modality

Description: The Access Modality category includes attributes that report the modality of exploitation of the resource.

Field Value
Access Right not available
Attribution

Description: Authorships and contributors

Field Value
Author Deng, Jie
Author Dietrich, Mary
Author Murphy, Barbara
Publishing

Description: Attributes about the publishing venue (e.g. journal) and deposit location (e.g. repository)

Field Value
Collected From Datacite
Hosted By figshare
Publication Date 2019-01-01
Publisher figshare
Additional Info
Field Value
Language UNKNOWN
Resource Type Collection
keyword FOS: Sociology
keyword FOS: Biological sciences
keyword FOS: Health sciences
system:type other
Management Info
Field Value
Source https://science-innovation-policy.openaire.eu/search/other?orpId=dedup_wf_001::2e8d45e32a3857eecf86ece9bcc055d2
Author jsonws_user
Last Updated 20 December 2020, 03:34 (CET)
Created 20 December 2020, 03:34 (CET)