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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02387320
• Other study ID #: 396717
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2014
• Last updated: September 16, 2015
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: September 2015
• Source: Samueli Institute for Information Biology
• Contact: Kimberly McConnell, EdD
• Phone: 210-916-1442
• Email: kmcconnell[@]SamueliInstitute.org
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anxiety
• Dyssomnias
• Fatigue
• Nausea
• Pain
• Parasomnias
• Sleep Disorders
• Sleep Disturbance

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	San Antonio Military Medical Center	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Samueli Institute for Information Biology	San Antonio Military Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from preoperative in VAS General Anxiety at post-operative	Anxiety is rated by the patient on a scale of 0 to 10, 0 being "not at all anxious" and 10 being "extremely anxious." This instrument will take up to 1 minute to complete.	Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)	No
Secondary	Change from pre-operative DVPRS at post-operative	The Defense and Veterans Pain Rating Scale (DVPRS) is a graphic tool to facilitate self-reported pain rating from patients. The instrument uses a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters." This instrument will take up to 1 minute to complete.	Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)	No
Secondary	Change from preoperative VAS Nausea at post- operative	Nausea is rated by the patient on a scale of 0 to 10, 0 being "no nausea" and 10 being "extreme nausea." This instrument will take up to 1 minute to complete.	Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)	No
Secondary	Change from baseline (PROMIS-57) Fatigue to pre-operative and follow-up 2 weeks post-operative	The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) profile measure (PROMIS-57) includes eight primary domains: anxiety, pain intensity, pain interference, fatigue, sleep disturbance, depression, physical function, and satisfaction with social roles. This instrument takes approximately 25 minutes to complete.	Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), follow-up 2 weeks post-operative	No
Secondary	Change from baseline (PROMIS-57) Sleep Disturbance to pre-operative and follow-up 2 weeks post-operative	The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) profile measure (PROMIS-57) includes eight primary domains: anxiety, pain intensity, pain interference, fatigue, sleep disturbance, depression, physical function, and satisfaction with social roles. This instrument takes approximately 25 minutes to complete.	Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), Follow-up 2 weeks post-operative	No