Breast Cancer
Conditions
Brief summary
The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.
Detailed description
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.
Interventions
BEHAVIORALIndividualized Manualized Health Education Intervention
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * Having received chemotherapy as part of their primary therapy for breast cancer * Be in complete remission * Aged 18 years or older * Able to read, write, and understand English * Karnofsky Performance Status (KPS) greater than or equal to 60 * Have impaired quality of life * Ability to give informed consent
Exclusion criteria
* Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary. * Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary. * Patients on adjuvant hormone therapy for less than 2 months * Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life over 6 months | Baseline, 3 months, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality over 6 months | Baseline, 3 months, 6 months | The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance. |
| Change in anxiety over 6 months | Baseline, 3 months, 6 months | The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety. |
| Change in fatigue over 6 months | Baseline, 3 months, 6 months | The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue. |
| Change in pain over 6 months | Baseline, 3 months, 6 months | The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function. |
| Change in diet over 6 months | Baseline, 3 months, 6 months | The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period. |
| Change in depressive symptoms over 6 months | Baseline, 3 months, 6 months | The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms. |
Countries
United States
Outcome results
None listed