Breast Neoplasms
Conditions
Keywords
psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer
Brief summary
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.
Detailed description
OBJECTIVES: * Design, implement, and evaluate an educational intervention and a nutrition education intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment. * Determine the processes through which the interventions affect quality of life. * Assess whether the interventions are differentially effective for different groups of women. * Determine how women who decline participation differ from those who participate. * Determine the nature and extent of adjustment difficulties, using baseline data, in younger women living in an urban setting who have been treated for early stage breast cancer. * Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention groups or a control condition. * Arm I (control group): Patients did not undergo any intervention. Patients were evaluated at baseline and at 4 and 13 months. * Arm II (breast cancer education group): Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Sessions involved the presentation of information concerning breast cancer, followed by a guided discussion of related topics. Sessions topics included: talking with children about cancer, life after diagnosis, relationships/intimacy, and hormones and breast cancer/basic factors of heredity. Patients were also given booklets and brochures to read at home. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention. * Arm III (nutritional education group): Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Sessions involved the presentation of information concerning nutrition, followed by a guided discussion of related topics. Session topics included: healthy cupboards, what's cooking, shopping for success, and out on the town. Patients were also asked to keep a 4 day record of diet. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.
Interventions
BEHAVIORALEducation Intervention
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.
BEHAVIORALNutrition Education Intervention
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.
Sponsors
National Cancer Institute (NCI)
Carnegie Mellon University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
(Disease Characteristics): * Diagnosis of breast cancer * Stage I or II disease * No more than 10 positive lymph nodes * First-time diagnosis * Under the age of 50 at diagnosis * 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): * Female patients only * Must be able to communicate
Exclusion criteria
(Patient Characteristics): * Other prior malignancies except skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | 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). |
| Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline, Post-intervention(4 months post-intervention), 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). |
Participant flow
Recruitment details
Potential participants were identified through nurse referrals of consecutive and potentially eligible patients from hospital medical oncology clinics and physicians' offices in southwestern Pennsylvania.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| 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. | 85 |
| Control Condition Participants received care as usual. | 84 |
| Total | 252 |
Baseline characteristics
| Characteristic | Education Intervention | Nutrition Education Intervention | Control Condition | Total |
|---|---|---|---|---|
| Age, Continuous | 43.7 years | 44.2 years | 44.6 years | 44.2 years |
| Race/Ethnicity, Customized African-American | 4 participants | 3 participants | 2 participants | 9 participants |
| Race/Ethnicity, Customized Caucasian | 79 participants | 80 participants | 82 participants | 241 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 0 participants | 2 participants |
| Sex: Female, Male Female | 83 Participants | 85 Participants | 84 Participants | 252 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 83 | 0 / 85 | 0 / 84 |
| serious Total, serious adverse events | 0 / 83 | 0 / 85 | 0 / 84 |
Outcome results
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.
Time frame: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).
Population: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Intervention | 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). | Post-intervention | 5.65 units on a scale | Standard Deviation 5.53 |
| Education Intervention | 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). | Baseline | 5.83 units on a scale | Standard Deviation 5.32 |
| Education Intervention | 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). | Final follow-up | 5.07 units on a scale | Standard Deviation 4.99 |
| Nutrition Education Intervention | 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). | Post-intervention | 5.70 units on a scale | Standard Deviation 5.45 |
| Nutrition Education Intervention | 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). | Baseline | 6.74 units on a scale | Standard Deviation 5.94 |
| Nutrition Education Intervention | 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). | Final follow-up | 4.36 units on a scale | Standard Deviation 4.49 |
| Control Condition | 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). | Baseline | 6.70 units on a scale | Standard Deviation 5.84 |
| Control Condition | 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). | Final follow-up | 6.88 units on a scale | Standard Deviation 6.19 |
| Control Condition | 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). | Post-intervention | 6.87 units on a scale | Standard Deviation 5.84 |
Comparison: Comparison between 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.p-value: >0.05Regression, Linear
Comparison: 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.p-value: >0.05Regression, Linear
Comparison: 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.p-value: =0.08Regression, Linear
Comparison: 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.p-value: <0.001Regression, Linear
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).
Time frame: Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)
Population: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Intervention | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Final Follow-up | 48.64 units on a scale | Standard Deviation 10.72 |
| Education Intervention | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Post-Intervention | 50.47 units on a scale | Standard Deviation 9.13 |
| Education Intervention | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline | 45.63 units on a scale | Standard Deviation 10.77 |
| Nutrition Education Intervention | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Final Follow-up | 51.26 units on a scale | Standard Deviation 8.27 |
| Nutrition Education Intervention | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline | 46.91 units on a scale | Standard Deviation 11.18 |
| Nutrition Education Intervention | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Post-Intervention | 50.38 units on a scale | Standard Deviation 9.06 |
| Control Condition | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Final Follow-up | 49.48 units on a scale | Standard Deviation 8.27 |
| Control Condition | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Post-Intervention | 49.27 units on a scale | Standard Deviation 9.06 |
| Control Condition | Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline | 45.76 units on a scale | Standard Deviation 10.69 |
Comparison: Comparison between 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 outcomep-value: >0.05Regression, Linear
Comparison: 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.p-value: >0.05Regression, Linear
Comparison: 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.p-value: >0.05Regression, Linear
Comparison: 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.p-value: >0.05Regression, Linear
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).
Time frame: Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)
Population: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Intervention | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Post-intervention | 52.03 units on a scale | Standard Deviation 7.02 |
| Education Intervention | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline | 49.21 units on a scale | Standard Deviation 8.19 |
| Education Intervention | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Final follow-up | 55.11 units on a scale | Standard Deviation 7.12 |
| Nutrition Education Intervention | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Post-intervention | 53.59 units on a scale | Standard Deviation 6.18 |
| Nutrition Education Intervention | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline | 50.38 units on a scale | Standard Deviation 8.26 |
| Nutrition Education Intervention | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Final follow-up | 53.90 units on a scale | Standard Deviation 5.55 |
| Control Condition | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Baseline | 49.16 units on a scale | Standard Deviation 8.26 |
| Control Condition | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Final follow-up | 50.93 units on a scale | Standard Deviation 9.14 |
| Control Condition | Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) | Post-intervention | 50.73 units on a scale | Standard Deviation 9.07 |
Comparison: Comparison between 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.p-value: >0.5Regression, Linear
Comparison: 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.p-value: =0.04Regression, Linear
Comparison: 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.p-value: <0.001Regression, Linear
Comparison: 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.p-value: =0.02Regression, Linear