Evidence map›Paper›PMID 31882012›Full record

ArticleTrials2019

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

Jie Deng, Mary S Dietrich, Barbara Murphy

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 30% 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.

NCT03030859 nacompletednot on this map

Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis

TypeinterventionalSponsorUniversity of PennsylvaniaRan2018 to 2022Enrolled59ConditionsHead and Neck Cancer, Lymphedema, FibrosisArmsUsual Care, Usual Care plus LEF-SCP, Usual Care plus LEF-SCP plus Follow-up
NCT04679233 nawithdrawnnot on this mapstarted 2021, after this paper: background citation

Feasibility and Preliminary Efficacy of Aerobic Exercise in Head and Neck Cancer Patients Undergoing Radiation Therapy

TypeinterventionalSponsorVanderbilt UniversityRan2021 to 2021Enrolled0ConditionsHead and Neck Neoplasm, RadiotherapyArmsPrescription aerobic exercise
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

3 authors at 3 institutions in 1 country.

Jie DengSchool of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, 19104-4217, USA. jiedeng@nursing.upenn.edu.ORCID http://orcid.org/0000-0002-2553-8822
Mary S DietrichSchool of Nursing, Vanderbilt University, Nashville, TN, USA.
Barbara MurphyVanderbilt-Ingram Cancer Center, Vanderbilt Medical Center, Nashville, TN, USA.
University of Pennsylvania · USVanderbilt-Ingram Cancer CenterVanderbilt University · US

Funding

AMERICAN CANCER SOCIETY RSG-16-207-01-PCSM
6 · The paper itself

Abstract

backgroundHead 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/

designThis 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 registrationClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

Indexed as

Head and Neck NeoplasmsLymphedemaQuality of LifeSelf CareAdaptation, PsychologicalAdultFibrosisHumansMotivationOutcome Assessment, Health CarePatient ParticipationPhysical Functional PerformanceRandomized Controlled Trials as TopicResearch DesignTreatment Adherence and ComplianceFibrosisHead and neck cancerLymphedemaSelf-careSelf-managementSurvivorship

Identifiers

PMID31882012
PMCPMC6935145
OpenAlexW2997285145

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.