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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA064711 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.
PURPOSE: To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention groups or a control condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Intervention | Experimental | Participants attended 4 2-hr education sessions. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness and its treatment, to enhance coping in productive ways with the issues and problems confronting them, and to facilitate communication between the participants and their partners. |
|
| Nutrition Education Intervention | Experimental | Participants attended 4 2-hr nutrition education sessions. Each session provided information and encouragement on setting and attaining measurable goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems in life and living a healthy lifestyle. |
|
| Control Condition | No Intervention | Participants received care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education Intervention | Behavioral | Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer and how to create a safe environment for them; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention). | Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample. | Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention). |
| Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health). | Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention) |
| Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health). | Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention) |
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INCLUSION CRITERIA (Disease Characteristics):
Diagnosis of breast cancer
Finished active treatment within the past 2 months
English-speaking only
Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania
INCLUSION CRITERIA (Patient Characteristics):
EXCLUSION CRITERIA (Patient Characteristics):
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Scheier, PhD | Pittsburgh Mind-Body Center at Carnegie Mellon University | Study Chair |
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Potential participants were identified through nurse referrals of consecutive and potentially eligible patients from hospital medical oncology clinics and physicians' offices in southwestern Pennsylvania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Education Intervention | Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways. Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read. |
| FG001 | Nutrition Education Intervention | Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle. The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it. |
| FG002 | Control Condition | Participants received care as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education Intervention | Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways. |
| BG001 | Nutrition Education Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention). | Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample. | All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention). |
|
13 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education Intervention | Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael F. Scheier, PhD | Carnegie Mellon University | 412-268-3791 | scheier@cmu.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Nutrition Education Intervention | Behavioral | The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it. |
|
Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle. |
| BG002 | Control Condition | Participants received care as usual. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Nutrition Education Intervention | Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle. |
| OG002 | Control Condition | Participants received care as usual |
|
|
|
| Primary | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health). | All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention) |
|
|
|
|
| Primary | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health). | All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention) |
|
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Nutrition Education Intervention | Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle. | 0 | 85 | 0 | 85 |
| EG002 | Control Condition | Participants received care as usual. | 0 | 84 | 0 | 84 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011314 | Preventive Health Services |
|
| Final follow-up |
|
Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome. |
| Regression, Linear |
| =0.04 |
| Standardized beta |
| 0.14 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome. | Regression, Linear | <0.001 | Standardized beta | 0.25 | 2-Sided | No | Superiority or Other |
| Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome. | Regression, Linear | =0.02 | Standardized beta | 0.15 | 2-Sided | No | Superiority or Other |
|
| Final Follow-up |
|
Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome. |
| Regression, Linear |
| >0.05 |
| No |
| Superiority or Other |
| Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome. | Regression, Linear | >0.05 | No | Superiority or Other |
| Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome. | Regression, Linear | >0.05 | No | Superiority or Other |