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

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ClinicalTrials.gov Identifier: NCT01073774
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : February 23, 2010
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Technical University of Braunschweig

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.


Condition or disease Intervention/treatment Phase
Enhancing Couples Coping Behavioral: Side by side Behavioral: couples control condition Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Side by Side Behavioral: Side by side
Active Comparator: couples control condition Behavioral: couples control condition




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: DFG
ClinicalTrials.gov Identifier: NCT01073774     History of Changes
Other Study ID Numbers: He61491994
DFG He61481994
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: February 2010

Keywords provided by Technical University of Braunschweig:
breast cancer couples coping