Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer

NCT ID: NCT01073774

Last Updated: 2010-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-12-31

Brief Summary

The diagnosis and treatment of cancer leads to emotional distress, and major disruptions in role functioning. Traditionally, psychosocial services offer individuals diagnosed with cancer peer group support or individual counseling with only few consideration of type or stage of cancer. Besides most cancers significantly impacting not only the individual but also their partners and families, breast and gynecological cancer may be particularly embedded in an interpersonal context, namely in the couple's relationship. Breast and gynecological cancer cause additional concerns about the women' body image, sexual functioning and these cancers may be prone to provoke or enhance maladaptive patterns of interaction between women and their partners. Thus, not only the individual but also the couple's functioning is threatened by these diagnoses.

The aim of the here proposed study is to identify predictors of couple's adjustment and to help couples to improve their ability to support each other during this time. In a multi-site study, we will evaluate the efficacy of a couple-based intervention entitled "Side by Side: Coping with Cancer Together ("Seite an Seite: Krebs Gemeinsam Bewältigen"). The intervention teaches couples relationship skills that have been repeatedly validated within the marital field. The aim of the intervention is to improve couples' skills to talk to each other effectively about cancer-related topics, and enhance (or maintain) an affectionate relationship in the face of death.

We will randomly assign 303 women recently diagnosed with either breast or gynecological cancer and their partners to one of two conditions: (1) Seite an Seite, or (2) Treatment-As-Usual, in which couples receive no active psychosocial intervention. Assessment will be conducted pre-, post-, and at 6 and 12 months follow-up. These assessments include for both partners negative and positive self-report measures of individual functioning (such as mood, anxiety and benefit finding) and relationship functioning (such as relationship distress, communication patterns). Furthermore, at pre-, post- and 12-month Follow-up observational data on mutual supportive behavior when communicating about a cancer-related topic will be collected. The study may enhance our understanding of the significance of relationship skills in the process of adjusting to cancer as a couple and as an individual.

Conditions

Enhancing Couples Coping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Side by Side

Group Type: EXPERIMENTAL

Side by side

Intervention Type: BEHAVIORAL

couples control condition

Group Type: ACTIVE_COMPARATOR

couples control condition

Intervention Type: BEHAVIORAL

Interventions

Side by side

Intervention Type: BEHAVIORAL

couples control condition

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• woman was recently diagnosed with breast cancer (Stage I - III)
• no history of other cancers
• woman and her male partner were married or have been living in a committed relationship for at least 12 month
• both partners are willing to participate and able to speak German

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Technische Universitaet Braunschweig

OTHER

Sponsor Role: lead

Responsible Party

DFG

Other Identifiers

DFG He61481994

Identifier Type: -

Identifier Source: secondary_id

He61491994

Identifier Type: -

Identifier Source: org_study_id