Recruiting

Self-Care Toolkit

Sponsor:

Samueli Institute for Information Biology

Code:

NCT02387320

Conditions

Anxiety

Pain

Nausea

Fatigue

Sleep Disturbance

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Self-Care Toolkit

Study Details

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.

Conditions

Anxiety

Pain

Nausea

Fatigue

Sleep Disturbance

Study ID

NCT02387320

Start date

Jul, 2014

Status verified date

May, 2016

Completion date

Feb, 2017

Anticipated

Primary completion date

Feb, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

experimental: Self-Care Toolkit

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.

no intervention: Standard Care

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.

Interventions

Self-Care Toolkit

The self-care toolkit was designed and created for individuals undergoing surgery and/or invasive medical procedures. It provides individuals with guided instruction to learn several evidence-informed mind-body skills (e.g., breathing, relaxation, meditation, guided imagery) and tools (e.g., acupressure wristbands, journal) in order to regulate their own physiologic and emotional reactions to stressful situations and to lessen symptoms associated with surgery (principally pain, anxiety, nausea, fatigue, sleep disturbance).

Primary outcome measure

  • Change from preoperative in VAS General Anxiety at post-operative [ Time Frame: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery) ]

Central Contacts and Locations

Central contacts

Locations

Carl R. Darnall Army Medical Center

Recruiting

Fort Hood, Texas, United States, 76544

Contacts

Principal Investigator:

Karin Nicholson, MD

San Antonio Military Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Principal Investigator:

Alice Inman, PsyD

More Information

Sponsor

Samueli Institute for Information Biology

Last update posted

May 12, 2016

Last verified

May, 2016

Keywords

  • Anxiety
  • Pain
  • Nausea
  • Fatigue
  • Sleep Disturbance
  • Breast Cancer
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Samueli Institute for Information Biology on 2016-05-12.