Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

9 aprile 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 45 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Couples Intervention
Single arm study design
Intervention delivered on line

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mental Psychological Development Questionnaire (MPDQ)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2008

Completamento primario (Effettivo)

1 luglio 2011

Completamento dello studio (Effettivo)

1 luglio 2011

Date di iscrizione allo studio

Primo inviato

15 ottobre 2009

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2011

Primo Inserito (Stima)

27 aprile 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 aprile 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 aprile 2013

Ultimo verificato

1 aprile 2011

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 200-2008

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro al seno

Prove cliniche su Psychosocial Intervention for Couples

3
Sottoscrivi