Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients



Status:Recruiting
Conditions:Anxiety, Anxiety, Chronic Pain, Insomnia Sleep Studies, Other Indications
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2014
End Date:November 2016
Contact:Kimberly McConnell, EdD
Email:kmcconnell@SamueliInstitute.org
Phone:210-916-1442

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This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to
determine the effectiveness of a self-care toolkit on specific symptoms associated with
surgery as compared to a standard care group.

The main research questions focus on whether the toolkit provides short-term benefits on
symptoms associated with surgery (i.e., pain, anxiety, nausea) and whether it impacts
emotional distress and other symptoms (i.e., pain, fatigue, sleep disturbance, global
health, quality of life) at a two-week post-operative time point. This study will be
conducted at San Antonio Military Medical Center (SAMMC) in active duty, veteran, and
military dependent women newly diagnosed with breast cancer for whom surgery (e.g.,
lumpectomy or mastectomy) is the initial treatment option. One to two weeks prior to
surgery, women diagnosed with breast cancer at SAMMC Oncology Department will be invited to
participate in this study. Those who meet criteria and agree to participate will be enrolled
on-study and randomly assigned to either the surgical toolkit group or standard care group.
During the pre-operative period, women in the intervention group will be asked to read
through the manual, listen to each of the 8 audiofiles at least once but as many times as
desired, and to wear the acupressure wristbands during surgery. Women randomized to the
standard care group will not receive an intervention prior to surgery but will receive the
toolkit at study completion. The rationale for providing women in the standard care group
with the toolkit at their post-operative visit is that the skills of breathing, meditation,
and guided imagery might be potentially beneficial for them to use during their subsequent
treatment or a future surgery. Additionally, qualitative interviews will be conducted in a
cohort of women from the intervention group, at a two-week post-operative time point to
assess their impressions and satisfaction with the toolkit; questions will focus on whether
the individual used each of the toolkit's components, frequency of use, how she would rate
the product's attributes (e.g., ease of use, clarity of instructions, quality rating,
helpfulness), and perceptions about the helpfulness and usefulness of learned mind-body
skills.

Inclusion Criteria:

- 18+ years of age

- Women treated at SAMMC Oncology clinic for newly-diagnosed breast cancer for whom
surgery (e.g., lumpectomy or mastectomy) is the initial treatment option

Exclusion Criteria:

- Women receiving chemotherapy, radiation or hormone therapy as first line treatment
for breast cancer (i.e., any of these treatment options prior to surgery)

- Severe hearing-impairment (i.e., that would interfere with ability to hear the
toolkit audiofiles)
We found this trial at
1
site
San Antonio, Texas
Principal Investigator: Alice Inman, PsyD
Phone: 210-916-1442
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mi
from
San Antonio, TX
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