Anxiety DisorderNCT01723943
Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients
A study testing educational intervention, counseling intervention and psychosocial support for caregiver in people with Anxiety Disorder and Depression, run by University of Washington at 1 site in United States.
Trial summary
This randomized clinical trial studies educational counseling in improving communication and quality of life in spouses and breast cancer patients. An outpatient education and behavior skills training program may help spouses and patients with breast cancer communicate better and improve quality of life. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ
- What is being tested?
- educational intervention, counseling intervention and psychosocial support for caregiver
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Spouses (in both heterosexual couples and same-sex couples) of women diagnosed within the past 6 months with stage 0, I, II or III breast cancer (in situ/local/regional disease) will be eligible to participate, as will the diagnosed wife/partner
- Spouses and patients must be married or cohabiting for at least 6 months
- Spouses and patients must have English as one of their languages of choice (they can be multilingual)
- Spouses and patients must live within 25 miles of the University of Washington (UW) study center
- Spouses/partners must be willing to give a sample of blood and/or sputum at time of first and second data collections
Who cannot join
- Woman diagnosed with stage IV or recurrent breast cancer or who is > 6 months post-diagnosis
- Woman and/or spouse not able to read and write in English
- Spouses could not participate if the ill partner refused participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Psychoeducation for Spouses/Partners of Women With Breast Cancer
This randomized clinical trial studies educational counseling in improving communication and quality of life in spouses and breast cancer patients. An outpatient education and behavior skills training program may help spouses and patients with breast cancer communicate better and improve quality of life. It is not yet known whether educational counseling is more effective than an educational booklet in improving communication and quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- To test whether the intervention has a beneficial effect on spouses' outcome variables.
II. To test whether the intervention has a beneficial effect on ill partners (patients') outcome variables.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants receive the "What's Happening to the Woman I Love?" booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis.
ARM II: Participants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart.
SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner.
SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience.
SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer.
SESSION IV: Participants learn strategies for physically reconnecting with spouses.
SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support.
After completion of study, patients are followed up at 3 and 6 months.
- Conditions
- Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Psychosocial Effects of Cancer and Its Treatment, Stage IA Breast Cancer
- Being tested
- educational intervention, counseling intervention, psychosocial support for caregiver
- Medical subject headings
- Anxiety Disorders, Depression, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Receive the "What's Happening to the Woman I Love?" booklet
counseling interventionOther
Also called counseling and communications studies
Undergo Helping Her Heal educational counseling program
educational interventionOther
Also called intervention, educational
Undergo Helping Her Heal educational counseling program
psychosocial support for caregiverOther
Undergo Helping Her Heal educational counseling program
| Study group | Role | What they receive |
|---|---|---|
| Arm I (educational booklet) | Active comparator | Participants receive the "What's Happening to the Woman I Love?" booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis. Receives: Other: educational intervention |
| Arm II (Helping Her Heal program) | Experimental | Participants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart.
SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner.
SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience.
SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer.
SESSION IV: Participants learn strategies for physically reconnecting with spouses.
SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support. Receives: Other: counseling intervention; Other: educational intervention; Other: psychosocial support for caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory (STAI) spouse scores
The primary analysis will be multivariate analysis of covariance (MANCOVA) with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include analysis of covariance (ANCOVA).
Measured: Baseline to 8 weeks
Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores
The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
Measured: Baseline to 8 weeks
Change in STAI patient scores
The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
Measured: Baseline to 8 weeks
Change in CES-D patient scores
The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
Measured: Baseline to 8 weeks
Secondary outcomes (4)
Change in spouse/partner Skills Checklist scores
Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
Measured: Baseline to 8 weeks
Change in spouse/partner CASE scores
Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
Measured: Baseline to 8 weeks
Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores
Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
Measured: Baseline to 8 weeks
Change in patient MIS scores
Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frances Lewis, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723943
- Sponsor's protocol ID
- 8061
- Other IDs
- NCI-2013-01838, 34500, 8061, P30CA015704, R01CA114561
- Status last verified
- Feb 2018
- First submitted
- 6 Nov 2012
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis FM, Griffith KA, Alzawad Z, Dawson PL, Zahlis EH, Shands ME. Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples. Psychooncology. 2019 Feb;28(2):430-438. doi: 10.1002/pon.4966. Epub 2018 Dec 28.
PubMed 30549145
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation for Spouses/Partners of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01723943
- Acronym / sponsor ID
- 8061
- Conditions
- Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Psychosocial Effects of Cancer and Its Treatment, Stage IA Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Nov 2012 (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.
This randomized clinical trial studies educational counseling in improving communication and quality of life in spouses and breast cancer patients. An outpatient education and behavior skills training program may help spouses and patients with breast cancer communicate better and improve quality of life. It is not yet known whether educational counseling is more effective than an educational booklet in improving communication and quality of life.
Detailed description
PRIMARY OBJECTIVES:
- To test whether the intervention has a beneficial effect on spouses' outcome variables.
II. To test whether the intervention has a beneficial effect on ill partners (patients') outcome variables.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants receive the "What's Happening to the Woman I Love?" booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis.
ARM II: Participants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart.
SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner.
SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience.
SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer.
SESSION IV: Participants learn strategies for physically reconnecting with spouses.
SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support.
After completion of study, patients are followed up at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (educational booklet) | Active comparator | Other: educational interventionParticipants receive the "What's Happening to the Woman I Love?" booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis. |
| Arm II (Helping Her Heal program) | Experimental | Other: counseling intervention, Other: educational intervention, Other: psychosocial support for caregiverParticipants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart. SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner. SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience. SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer. SESSION IV: Participants learn strategies for physically reconnecting with spouses. SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Spouses (in both heterosexual couples and same-sex couples) of women diagnosed within the past 6 months with stage 0, I, II or III breast cancer (in situ/local/regional disease) will be eligible to participate, as will the diagnosed wife/partner
- Spouses and patients must be married or cohabiting for at least 6 months
- Spouses and patients must have English as one of their languages of choice (they can be multilingual)
- Spouses and patients must live within 25 miles of the University of Washington (UW) study center
- Spouses/partners must be willing to give a sample of blood and/or sputum at time of first and second data collections
Key exclusion criteria (3 listed)
- Woman diagnosed with stage IV or recurrent breast cancer or who is > 6 months post-diagnosis
- Woman and/or spouse not able to read and write in English
- Spouses could not participate if the ill partner refused participation
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalReceive the "What's Happening to the Woman I Love?" booklet | Other | Arm I (educational booklet) |
| counseling interventionAlso: counseling and communications studiesUndergo Helping Her Heal educational counseling program | Other | Arm II (Helping Her Heal program) |
| educational interventionAlso: intervention, educationalUndergo Helping Her Heal educational counseling program | Other | Arm II (Helping Her Heal program) |
| psychosocial support for caregiverUndergo Helping Her Heal educational counseling program | Other | Arm II (Helping Her Heal program) |
Primary outcome
Change in State-Trait Anxiety Inventory (STAI) spouse scores
Time frame: Baseline to 8 weeks
The primary analysis will be multivariate analysis of covariance (MANCOVA) with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include analysis of covariance (ANCOVA).
Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores
Time frame: Baseline to 8 weeks
The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
Change in STAI patient scores
Time frame: Baseline to 8 weeks
The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
Change in CES-D patient scores
Time frame: Baseline to 8 weeks
The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
4 secondary outcomes
Change in spouse/partner Skills Checklist scores
Time frame: Baseline to 8 weeks
Change in spouse/partner CASE scores
Time frame: Baseline to 8 weeks
Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores
Time frame: Baseline to 8 weeks
Change in patient MIS scores
Time frame: Baseline to 8 weeks
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 8 Feb 2018.
- Derived from this study: PubMed 30549145Lewis FM, Griffith KA, Alzawad Z, Dawson PL, Zahlis EH, Shands ME. Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples. Psychooncology. 2019 Feb;28(2):430-438. doi: 10.1002/pon.4966. Epub 2018 Dec 28.
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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.
Frances Lewis principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, counseling intervention and psychosocial support for caregiver in people with Anxiety Disorder and Depression, run by University of Washington at 1 site in United States.
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 5 inclusion and 3 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
What does the primary outcome measure?
Change in State-Trait Anxiety Inventory (STAI) spouse scores (time frame: Baseline to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723943, which also lists 1 linked publication.
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 8 Feb 2018.