Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Promoting Adherence to Lymphedema Self-care

7 april 2017 bijgewerkt door: Sheila Ridner, Vanderbilt University

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong. Previous studies found that about half of breast cancer survivors with lymphedema do not complete self-care as directed. Feelings of being helpless to manage the condition, a desire to be normal, lack of noticeable results from self-care, and poor social/healthcare professional support are barriers to performing self-care on a regular basis. There is a need to develop and test interventions to promote effective self-care. Experts suggest the best self-care interventions should include patient perspectives and be available a readily accessible format. Technological advancements support use of innovative, creative approaches, such as Web-based multimedia interventions. Web-based interventions can be used in rural and urban settings. The investigators are proposing to develop a Web-based, multimedia intervention and a "take home" manual to support self-care in breast cancer survivors with lymphedema. The investigators plan to conduct focus groups with these survivors to determine the content and delivery format(s) and to help us identify breast cancer survivors with lymphedema for the video component. The investigators will then develop an intervention that will include self-care demonstrations and other supportive information to help patients to cope with the challenges of self-care. The focus groups will reconvene, review the intervention, and give us feedback on modifying and refining the intervention. After finalizing the intervention, The investigators will recruit more breast cancer survivors with lymphedema and provide one half of them an education booklet and the other half the Web-based intervention (or an alternative format such as DVD). Then, over 12 months, the investigators will periodically assess and compare both groups on self-care behaviors, physical and emotional concerns, and other issues such as money spent on lymphedema treatment. The group that receives the education booklet will be given access to the Web-based intervention after the 12 month follow-up is done, but the investigators will not ask them to complete any more forms.

This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals. By providing accessible, detailed self-care instructions and a psychosocial component, this intervention has the potential to improve lymphedema self-care. If successful, this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

160

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37072
        • Vanderbilt Univeristy School Of Nursing

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. have a history of breast cancer;
  2. previous diagnosis of lymphedema;
  3. Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted);
  4. be age 18 or older;
  5. be able to see and read printed documents in English; and for stage 2 only,
  6. have access to the Internet or a smart phone.

Exclusion Criteria: will not be:

  1. undergoing chemotherapy or radiation, or
  2. receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: web based multimedia intervention
interactive,web based multimedia intervention
cognitive therapy based web intervention
Actieve vergelijker: education booklet
printed educational booklet
patient education booklet

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
symptom burden
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report of symptoms will be documented on study instruments
change between baseline and 1, 3, 6, and 12 months post-intervention
function
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
Self-report functional data using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
psychological well-being
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
coping
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
self-care activities
Tijdsspanne: Change between baseline 1, 3, 6, and 12 months post-intervention
self report using a self-care checklist
Change between baseline 1, 3, 6, and 12 months post-intervention
stress
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
self-efficacy
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
social support
Tijdsspanne: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
extracellular fluid
Tijdsspanne: change between baseline and 3, 6, and 12 months post-intervention
bioelectrical impedence measurement for sub set of participants
change between baseline and 3, 6, and 12 months post-intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2013

Primaire voltooiing (Werkelijk)

1 december 2016

Studie voltooiing (Werkelijk)

1 december 2016

Studieregistratiedata

Eerst ingediend

23 januari 2013

Eerst ingediend dat voldeed aan de QC-criteria

25 januari 2013

Eerst geplaatst (Schatting)

30 januari 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 april 2017

Laatste update ingediend die voldeed aan QC-criteria

7 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 124137-RSG-13-022-01-CPPB

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren