Clinical trial NCT02387320: Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
Official title: Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Pain
Nausea
Fatigue
Sleep Disturbance
Keywords: Anxiety
Pain
Nausea
Fatigue
Sleep Disturbance
Breast Cancer
Surgery
Lead sponsor: Samueli Institute for Information Biology
Sponsor class: OTHER
Collaborators: name: San Antonio Military Medical Center
name: United States Department of Defense
First posted: 2015-03-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* Women treated at SAMMC Oncology clinic or CRDAMC 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)

Primary outcomes:
measure: Change from preoperative in VAS General Anxiety at post-operative
timeFrame: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
Secondary outcomes:
measure: Change from pre-operative DVPRS at post-operative
timeFrame: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
measure: Change from preoperative VAS Nausea at post- operative
timeFrame: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
measure: Change from baseline (PROMIS-57) Fatigue to pre-operative and follow-up 2 weeks post-operative
timeFrame: Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), follow-up 2 weeks post-operative
measure: Change from baseline (PROMIS-57) Sleep Disturbance to pre-operative and follow-up 2 weeks post-operative
timeFrame: Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), Follow-up 2 weeks post-operative
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Samueli Institute
name: Kimberly McConnell, EdD
role: PRINCIPAL_INVESTIGATOR
References: