AnxietyNCT02387320
Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
A study testing Self-Care Toolkit in people with Anxiety and Pain, run by Samueli Institute for Information Biology at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Self-Care Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
Ames Davis, AA, 571-733-7145, adavis@siib.org
Karin Nicholson, MD
- Recruiting
San Antonio Military Medical Center
San Antonio, Texas, 78234
Kimberly McConnell, EdD, 210-916-1442, kmcconnell@SamueliInstitute.org
Alice Inman, PsyD
About this study
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.
Read the 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.
- Conditions
- Anxiety, Pain, Nausea, Fatigue, Sleep Disturbance
- Being tested
- Self-Care Toolkit
- Keywords
- Anxiety, Pain, Nausea, Fatigue, Sleep Disturbance, Breast Cancer, Surgery
- Medical subject headings
- Anxiety Disorders, Pain, Nausea, Fatigue, Parasomnias, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care ToolkitOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Self-Care Toolkit | Experimental | 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. Receives: Other: Self-Care Toolkit |
| Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
Secondary outcomes (4)
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.
Measured: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
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.
Measured: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
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.
Measured: Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), follow-up 2 weeks post-operative
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.
Measured: Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), Follow-up 2 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- San Antonio Military Medical Center, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kimberly McConnell, EdD, Principal investigator, Samueli Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387320
- Sponsor's protocol ID
- 396717
- Status last verified
- May 2016
- First submitted
- 17 Nov 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02387320
- Acronym / sponsor ID
- 396717
- Conditions
- Anxiety, Pain, Nausea, Fatigue, Sleep Disturbance
- Keywords
- Anxiety, Pain, Nausea, Fatigue, Sleep Disturbance, Breast Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- San Antonio Military Medical Center, United States Department of Defense
- Study start
- Jul 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Care Toolkit | Experimental | Other: Self-Care ToolkitWomen 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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Care ToolkitThe 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). | Other | Self-Care Toolkit |
Primary outcome
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)
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.
4 secondary outcomes
Change from pre-operative DVPRS at post-operative
Time frame: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
Change from preoperative VAS Nausea at post- operative
Time frame: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
Change from baseline (PROMIS-57) Fatigue to pre-operative and follow-up 2 weeks post-operative
Time frame: Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), follow-up 2 weeks post-operative
Change from baseline (PROMIS-57) Sleep Disturbance to pre-operative and follow-up 2 weeks post-operative
Time frame: Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), Follow-up 2 weeks post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly McConnell, EdD principal investigator
Samueli Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Toolkit in people with Anxiety and Pain, run by Samueli Institute for Information Biology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly McConnell, EdD (210-916-1442, kmcconnell@SamueliInstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.