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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.
Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. The investigators aim to develop and test a Health Education intervention in breast cancer survivors. Specifically, the investigators aim to develop the manualized Health Education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. The data from this pilot study will be used to inform future study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Education Intervention | Experimental | Study participants will attend Health Education sessions led by health educators over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Manualized Health Education Intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life over 6 months | The investigators will use the EORTC QLQ C30 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms. | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue over 6 months | The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue. | Baseline, 3 months, 6 months |
| Change in sleep quality over 6 months | The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand Dhruva, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco, Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
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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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| Baseline, 3 months, 6 months |
| Change in anxiety over 6 months | The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety. | Baseline, 3 months, 6 months |
| Change in depressive symptoms over 6 months | The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms. | Baseline, 3 months, 6 months |
| Change in pain over 6 months | The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function. | Baseline, 3 months, 6 months |
| Change in diet over 6 months | The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period. | Baseline, 3 months, 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |