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| ID | Type | Description | Link |
|---|---|---|---|
| P50HL065111 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The present study sought to investigate the efficacy of two psychosocial interventions for breast cancer patients, a peer support intervention and an education intervention. The present study also sought to identify mechanisms underlying the benefits of these interventions, and to determine if the efficacy of these interventions is moderated by cancer severity.
BACKGROUND:
The study was a subproject within a Mind-Body Center on Understanding Shared Psychobiological Pathways. The Center was in response to a Request for Applications issued by the Office of the Director, NIH. Dr. Scheier was the Co-Director of the Center as well as the subproject principal investigator. The major objective of the Center was to to identify, measure, and understand the shared psychological, behavioral, and psychobiological pathways that contributed to the onset of and recovery from diverse physical illnesses, which included infections, arthritis, cancer, and cardiovascular disease.
The subproject studied an important area of psychosocial research in cancer, specially the relative effectiveness of different psychosocial interventions for women with breast cancer, and the mechanisms that underlie the benefits of these interventions.
DESIGN NARRATIVE:
The specific aims of the project were to:
Participants included 180 patients with early stage (I or II) and 65 patients with late stage (IV) breast cancer. The interventions were conducted in groups of 6-9 women, and groups met once a week for 8 weeks. The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Participants were asked to share experiences and problems in group meetings and the group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. Participants in the control condition received care as usual, and did not attend any group meetings.
Hypothesized predictors, mediators, and relevant outcome measures were assessed prior to the intervention. Mediators and outcomes were then reassessed, 2-weeks after intervention completion and 6-months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Tracking (control) | No Intervention | Participants assigned to the health-tracking condition received usual care and did not attend any meetings. | |
| Peer support | Experimental | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. |
|
| Education | Experimental | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 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 72 (high levels of mental health) to a minimum of 12 (low levels of mental health). | Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention) |
| Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 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 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health). | Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention) |
| Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 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 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample. | Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention) |
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Eligible participants were:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Scheier | Carnegie Mellon University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. | |
| 8037935 | Background | Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84. |
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Participants were recruited from local oncologists' offices. We contacted 915 eligible patients, of whom 245 provided informed consent and were randomized to an intervention group. The most frequently reported reasons for refusal were unwillingness/inability to drive to group meeting site (37.2%) and being too busy (29.4%).
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Tracking (Control) | Participants assigned to the health-tracking condition received usual care and did not attend any meetings. |
| FG001 | Peer Support | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. |
| FG002 | Education | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Tracking (Control) | Participants assigned to the health-tracking condition received usual care and did not attend any meetings. |
| BG001 | Peer Support | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 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 72 (high levels of mental health) to a minimum of 12 (low levels of mental health). | The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention) |
|
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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 | Health Tracking (Control) | Participants assigned to the health-tracking condition received usual care and did not attend any meetings. |
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The study was originally planned as a 2(early stage, late stage) X 3(education intervention, peer support intervention, control condition) design; however, the education condition for the late stage cancer group was dropped, due to slow recruitment.
| 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 |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| Peer support | Behavioral | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. |
|
| BG002 | Education | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Peer Support | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. |
| OG002 | Education | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. |
|
|
|
| Primary | Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 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 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health). | The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention) |
|
|
|
|
| Primary | Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 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 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample. | The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention) |
|
|
|
|
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Peer Support | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. | 0 | 94 | 0 | 94 |
| EG002 | Education | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. | 0 | 60 | 0 | 60 |
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| D017437 |
| Skin and Connective Tissue Diseases |
|
| Time 3 |
|
| The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Linear | >0.05 | 2-Sided | Superiority or Other (legacy) |
|
| Time 3 |
|
| The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |
| The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis. | Regression, Logistic | >0.05 | 2-Sided | Superiority or Other (legacy) |