Enhancing Couples CopingPhase 2Side by SideNCT01073774
Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer
A Phase 2 study testing Side by side in people with Enhancing Couples Coping, run by Technische Universitaet Braunschweig.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Enhancing Couples Coping
- What is being tested?
- Side by side
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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
- Being tested
- Side by side, couples control condition
- Keywords
- breast cancer couples coping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side by sideBehavioural
couples control conditionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Side by Side | Experimental | Not described Receives: Behavioral: Side by side |
| couples control condition | Active comparator | Not described Receives: Behavioral: couples control condition |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhancing Couples CopingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Technische Universitaet Braunschweig
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073774
- Sponsor's protocol ID
- He61491994
- Other IDs
- DFG He61481994
- Acronym
- Side by Side
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer
- ClinicalTrials.gov ID
- NCT01073774
- Acronym / sponsor ID
- Side by Side / He61491994
- Conditions
- Enhancing Couples Coping
- Keywords
- breast cancer couples coping
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universitaet BraunschweigUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side by Side | Experimental | Behavioral: Side by side |
| couples control condition | Active comparator | Behavioral: couples control condition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Side by side | Behavioural | Side by Side |
| couples control condition | Behavioural | couples control condition |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Side by side in people with Enhancing Couples Coping, run by Technische Universitaet Braunschweig.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2010.