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

NCT01342302 | Completed

• 1 other identifier: 200-2008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Couples; Distress; Online Support; e-health; Intervention; Relationships

Outcome Measures

Primary Outcomes (2)

• Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to 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)

  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)

Secondary Outcomes (6)

• Mental Psychological Development Questionnaire (MPDQ)

  Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).

• Mental Health Inventory (MHI)

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

• Hospital Anxiety and Depression Scale (HADS)

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

• Functional Assessment of Cancer Therapy-Breast (FACT-B)

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

• Breast Cancer and Relationship Measure

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

Study Arms (1)

Couples Intervention

OTHER

Single arm study design

Behavioral: Psychosocial Intervention for Couples

Interventions

Psychosocial Intervention for Couples BEHAVIORAL

Intervention delivered on line

Couples Intervention

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychosocial Intervention; Family Characteristics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Karen Fergus, PhD

  Toronto Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

• Debbie McLeod, PhD, RN

  Cancer Care Program, Nova Scotia Cancer Centre

  STUDY DIRECTOR

• Ellen Warner, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY DIRECTOR

• Sandra Gardner, PhD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY DIRECTOR

• Margaret Fitch, RN

  Toronto Sunnybrook Regional Cancer Centre

  STUDY DIRECTOR

• Barbara Fitzgerald, RN

  Princess Margaret Hospital, Canada

  STUDY DIRECTOR

• Leeat Granek, PhD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: April 27, 2011
• Study Start: September 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 10, 2013

Record last verified: 2011-04

Locations

CA (1)