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

Samueli Institute for Information Biology

Status: Unknown

Conditions: Nausea; Sleep Disturbance; Fatigue; Anxiety; Pain

Treatments: Other: Self-Care Toolkit

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02387320

396717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 2 patient groups

Self-Care Toolkit

Experimental group

Description:

Women randomized to self-care toolkit group will receive a toolkit which includes a spiral-bound instruction manual, a section of the manual that can be used as a journal, a portable mp3 player with 8 audiofile tracks with guided meditations to reduce stress and anxiety, and two acupressure wristbands to help prevent nausea.

Treatment:

Other: Self-Care Toolkit

Standard Care

No Intervention group

Description:

Women randomized to the standard care group will be informed that they will continue to receive standard of care as delivered by the SAMMC Oncology Department. The research team will inform women randomized to standard care that they will receive the self-care toolkit at their two week post-operative visit and will be able to use it subsequently if they choose to.