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Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners (HIH)

25. februar 2015 opdateret af: Anne Nicolaisen, University of Southern Denmark

Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.

This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment.

The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care.

The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

198

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Herlev, Danmark, 2730
        • Herlev University Hospital
      • Odense, Danmark, 5000
        • Odense University Hospital
      • Ringsted, Danmark, 4100
        • Ringsted Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women newly diagnosed with a primary breast cancer (in the last 4 weeks)
  • Women cohabiting with a male partner in a romantic relationship
  • Patient and partner speaks and reads danish

Exclusion Criteria:

  • Patients having a previous cancer diagnosis
  • Neoadjuvant therapy for breast cancer
  • Previous hospital admission with diagnosed psychotic episodes

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Sædvanlig pleje
Eksperimentel: Psychological Intervention
Adfærdsmæssigt: Psychological intervention
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Impact of Event Scale (IES)
Tidsramme: Baseline, 2 weeks post-intervention, 10 months follow-up
IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
Baseline, 2 weeks post-intervention, 10 months follow-up
Change in The Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Baseline, 2 weeks post-intervention, 10 months follow-up
Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.
Baseline, 2 weeks post-intervention, 10 months follow-up
Change in The Profile of Mood States - Short Form (POMS-SF)
Tidsramme: Baseline, 2 weeks post-intervention, 10 months follow-up
Assesses mood changes. Assessed by both patients and partners
Baseline, 2 weeks post-intervention, 10 months follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Dyadic Adjustment Scale - Revised (DAS-R)
Tidsramme: Baseline, 2 weeks post-intervention, 10 months follow-up
Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners
Baseline, 2 weeks post-intervention, 10 months follow-up
Change in Relationship Questionnaire (RQ)
Tidsramme: Baseline, 2 weeks post-intervention, 10 months follow-up
RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners
Baseline, 2 weeks post-intervention, 10 months follow-up
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
Tidsramme: Baseline, 2 weeks post-intervention and 10 months follow-up
Assesses health-related quality of life with additional questions for women dignosed with breast cancer.
Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
Tidsramme: Baseline, 2 weeks post-intervention and 10 months follow-up
Assesses health-related quality of life. Assessed by partners
Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Functional Assessment of Chronic Illness Therapy-Fatigue
Tidsramme: Baseline, 2 weeks post-intervention and 10 months follow-up
Assesses individual fellings of fatigue. Assessed by the patients
Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Post Traumatic Growth Inventory
Tidsramme: 2-weeks post-intervention and 10 months follow-up
Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners
2-weeks post-intervention and 10 months follow-up
Change in EuroQol-5 Dimensions (EQ-5D)
Tidsramme: Baseline, 2 weeks post-intervention and 10 months follow-up
Assesses health-related quality of life. Assessed by both patients and partners
Baseline, 2 weeks post-intervention and 10 months follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern Denmark

Samarbejdspartnere

Odense University Hospital
University of Copenhagen
Danish Cancer Society
Region of Southern Denmark
Ringsted Hospital

Efterforskere

  • Ledende efterforsker: Dorte G Hansen, PhD, University of Southern Denmark
  • Studiestol: Mariët Hagedoorn, Professor, University of Groningen
  • Studiestol: Christoffer Johansen, Professor, Danish Cancer Society
  • Studiestol: Henrik Flyger, MD, Ph. D, University of Copenhagen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

23. maj 2011

Først indsendt, der opfyldte QC-kriterier

6. juni 2011

Først opslået (Skøn)

7. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NFK-SDU-2011-5

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsor / samarbejdspartnere

Placeringer

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