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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Technical University of Braunschweig
ClinicalTrials.gov Identifier:
NCT01073774
First received: February 22, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention Phase
Enhancing Couples Coping
Behavioral: Side by side
Behavioral: couples control condition
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer

Resource links provided by NLM:


Further study details as provided by Technical University of Braunschweig:

Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Side by Side Behavioral: Side by side
Active Comparator: couples control condition Behavioral: couples control condition

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: DFG
ClinicalTrials.gov Identifier: NCT01073774     History of Changes
Other Study ID Numbers: He61491994, DFG He61481994
Study First Received: February 22, 2010
Last Updated: February 22, 2010
Health Authority: Germany: German Research Foundation

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

ClinicalTrials.gov processed this record on July 24, 2014