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


N/A
20 Years
45 Years
Not Enrolling
Both
Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)

Outcome Description:

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).

Outcome Time Frame:

pre-treatment (0 weeks) and immediate post-treatment (7 weeks)

Safety Issue:

No

Principal Investigator

Karen Fergus, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Odette Cancer Centre

Authority:

Canada: Health Canada

Study ID:

200-2008

NCT ID:

NCT01342302

Start Date:

September 2008

Completion Date:

July 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Couples
  • Distress
  • Online Support
  • e-health
  • Intervention
  • Relationships
  • Breast Neoplasms

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