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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to review and evaluate the effectiveness of new educational materials (informational booklet & DVD) that promote participation in genetic counseling among breast cancer survivors.
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
Part 1: Intervention Development
Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).
Part 2: Intervention Pilot
Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC patients and health care professionals.
Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical care. We hypothesize that women in the intervention group will have higher uptake of GC, greater increases in knowledge, and more perceived benefits related to GC compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Development | No Intervention | Psychoeducational Intervention (PEI) development. PEIs include printed and DVD materials, and represent a commonly used and effective approach to implement theoretically based individual-level interventions. These materials serve as important sources of information for the general public, cancer patients, and survivors from a variety of backgrounds, including populations with limited health literacy. An interview and feedback collection process will take place to provide data to improve current PEI materials. | |
| Intervention Pilot - Intervention Group | Experimental | The intervention group will receive the PEI materials: video and booklet. Self-reported feedback will be collected and reviewed to compare response with the control group. |
|
| Intervention Pilot - Control Group | Active Comparator | The control group will receive a patient factsheet about Genetic Counseling (GC). Self-reported feedback will be collected and reviewed to compare response with the intervention group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video and Booklet | Behavioral | Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Rate of Initial Survey Responses | Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation. | Up to 8 months |
| Part 2: Rate of Participation | Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group. | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Impact | Self-Reported Feedback Scoring Method: Frequencies and descriptives will be calculated for response options. Positive feedback rate of Psychoeducational Intervention (PEI) group compared to the Factsheet group. | Up to 8 months |
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Inclusion Criteria:
Part 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they:
Part 2: Female BC patients at MCC are eligible to participate if they:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Vadaparampil | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| Factsheet | Behavioral | Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |