- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01342302
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Odette Cancer Centre
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Couples Intervention
Single arm study design
|
Intervention delivered on line
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
Časové okno: 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)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mental Psychological Development Questionnaire (MPDQ)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Karen Fergus, PhD, Toronto Sunnybrook Regional Cancer Centre
- Ředitel studie: Debbie McLeod, PhD, RN, Cancer Care Program, Nova Scotia Cancer Centre
- Ředitel studie: Ellen Warner, MD, Toronto Sunnybrook Regional Cancer Centre
- Ředitel studie: Sandra Gardner, PhD, Toronto Sunnybrook Regional Cancer Centre
- Ředitel studie: Margaret Fitch, RN, Toronto Sunnybrook Regional Cancer Centre
- Ředitel studie: Barbara Fitzgerald, RN, Princess Margaret Hospital, Canada
- Ředitel studie: Leeat Granek, PhD, Toronto Sunnybrook Regional Cancer Centre
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 200-2008
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