| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01838 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 34500 | |||
| 8061 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| R01CA114561 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Receive the "What's Happening to the Woman I Love?" booklet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Lewis | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30549145 | Derived | 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. |
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| counseling intervention | Other | Undergo Helping Her Heal educational counseling program |
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| educational intervention | Other | Undergo Helping Her Heal educational counseling program |
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| psychosocial support for caregiver | Other | Undergo Helping Her Heal educational counseling program |
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| 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. | 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. | 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. | Baseline to 8 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| D003376 | Counseling |
| D000067250 | Psychiatric Rehabilitation |
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006282 | Health Personnel |
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