Integrative Approaches for Cancer Survivorship 2: Project 2

Study Overview
=================
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.

Official Title
-----------------
Developing a Health Education Intervention for Breast Cancer Survivorship

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Individualized Manualized Health Education Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Education Intervention<br>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. | Behavioral: Individualized Manualized Health Education Intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |