Ignite Creation Date:
2024-05-05 @ 10:17 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01073774
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2010-02-22
Brief Title:
Side by Side - Prediction of Couples Adjustment to Breast or Gynecological Cancer
Sponsor:
Technische Universitaet Braunschweig
Organization:
Technische Universitaet Braunschweig
Study Overview
Official Title:
Side by Side - Prediction of Couples Adjustment to Breast or Gynecological Cancer
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Side by Side
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 couples 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 couples functioning is threatened by these diagnoses
The aim of the here proposed study is to identify predictors of couples 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
The aim of the here proposed study is to identify predictors of couples 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DFG He61481994 | None | None | None |