- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01342302
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Odette Cancer Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Couples Intervention
Single arm study design
|
Intervention delivered on line
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: 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
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 200-2008
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