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An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)

9. april 2013 opdateret af: Karen Fergus, Sunnybrook Health Sciences Centre
Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Presently, there are virtually no resources designed specifically to assist young couples coping with breast cancer. The purpose of this study is to develop and evaluate an online educational program geared to the unique needs and demanding schedules of young couples. The purpose of the program is to improve couples' relationships and mutual coping. Seventeen couples will take part in the 7-week program. They will complete questionnaires before and after participating to evaluate the program's helpfulness. This study will allow for the creation of a user-friendly, cost-effective tool that could help to improve the lives of all young couples coping with breast cancer in the years to come.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Women diagnosed with breast cancer at or before the age of 40 experience greater distress and poorer quality of life than women diagnosed later in life. In addition to having to cope with the range of issues common to all women with breast cancer, young women face unique challenges such as loss of fertility, concerns for young children, and interruptions to early-stage careers. The presence of adequate social support is a mitigating factor for distress in young women, and spousal support in particular has been shown to play a crucial and distinctive role in determining how well a woman adjusts to breast cancer. Unfortunately, the evidence suggests well-spouses are significantly distressed themselves, and often fall short in their attempts to meet the needs of their ill partners despite generally good intentions. Consequently, researchers have recommended that psychosocial interventions be geared to couples. However, traditional counseling interventions may not appeal to younger couples with numerous responsibilities and time constraints.

The purpose of this study is to examine the feasibility, process, and outcomes of an innovative online intervention tailored to the unique needs of young women and their partners. The primary goal is to improve partners' relationship functioning and capacity to work together as a team in relation to the illness. The secondary goal is to combat feelings of isolation by creating a community of similarly affected couples. The intervention will be delivered via a professionally moderated, password-protected website and entail: Information relevant to young couples with breast cancer; structured, interactive learning modules; and a discussion board. The online modality is particularly suited to the younger demographic targeted by this project because of its familiarity, comfort, convenience, and flexibility.

A non-randomized, repeated measures analysis of variance design will be used to test the intervention. Seventeen couples will be recruited within the Greater Toronto Area. Questionnaires assessing relationship functioning, psychological adjustment, and quality of life will be administered to participants at baseline and at completion of the 7-week program. Qualitative data from the website and treatment satisfaction questionnaire will be analyzed thematically in order to improve the intervention and its delivery.

The potential for this online intervention to fill a void in support options available to both young women with breast cancer and their partners is vast. Following completion of the project, not only will there be a demonstrable product in the website, but the investigators will have the knowledge with which to further test the intervention in a RCT. The ultimate impact of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help to improve the quality of life of all young couples coping with breast cancer, regardless of geographic location, in the years to come.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre

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

20 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • woman has received a diagnosis of breast carcinoma within the last 18 months at any point in her treatment trajectory.
  • Women must be free of known local recurrence or metastatic disease at the time of enrolment.
  • Patients will have been 40 years of age or younger when diagnosed.
  • Partners must be 45 years of age or younger at the time of diagnosis. - Couples must be heterosexual, and married, cohabitating, or engaged. - Participants must be fluent in English with the ability to read and write in English.
  • All participants will require convenient access to a computer with internet connection.

Exclusion Criteria:

  • All participants will be screened for mental illness that would interfere with their capacity to benefit from the program (e.g., suicidality, psychotic disorders, substance abuse) and excluded on this basis.
  • Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Couples Intervention
Single arm study design
Intervention delivered on line

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
Tidsramme: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
The DAS assesses couple's level of relationship satisfaction. The DAS will be used to assess change in couples' level of relationship satisfaction following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)
Tidsramme: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
The Personal Assessment of Intimacy in Relationships scale assesses the degree of feelings of intimacy between partners. This primary outcome measure will be used to assess changes in the degree of the feelings of intimacy between partners following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mental Psychological Development Questionnaire (MPDQ)
Tidsramme: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
The MPDQ assesses individual psychological adjustment.
Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
Mental Health Inventory (MHI)
Tidsramme: pre-treatment (0 weeks) and post-treatment (7 weeks)
The MHI assesses individual psychological adjustment.
pre-treatment (0 weeks) and post-treatment (7 weeks)
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
The HADS assesses individual psychological adjustment.
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Tidsramme: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Breast Cancer and Relationship Measure
Tidsramme: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
This measure assesses the impact of breast cancer on couple mutuality.
pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Treatment Expectancy and Motivation Measure (TEMM)
Tidsramme: pre-treatment (0 weeks)
The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.
pre-treatment (0 weeks)

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Karen Fergus, PhD, Toronto Sunnybrook Regional Cancer Centre
  • Studieleder: Debbie McLeod, PhD, RN, Cancer Care Program, Nova Scotia Cancer Centre
  • Studieleder: Ellen Warner, MD, Toronto Sunnybrook Regional Cancer Centre
  • Studieleder: Sandra Gardner, PhD, Toronto Sunnybrook Regional Cancer Centre
  • Studieleder: Margaret Fitch, RN, Toronto Sunnybrook Regional Cancer Centre
  • Studieleder: Barbara Fitzgerald, RN, Princess Margaret Hospital, Canada
  • Studieleder: Leeat Granek, PhD, Toronto Sunnybrook Regional Cancer Centre

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. september 2008

Primær færdiggørelse (Faktiske)

1. juli 2011

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

15. oktober 2009

Først indsendt, der opfyldte QC-kriterier

26. april 2011

Først opslået (Skøn)

27. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2013

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 200-2008

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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Kliniske forsøg med Psychosocial Intervention for Couples

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