Clinical trial · Interventional
Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
NCT02387320CI-TRIAL-00022105unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Nausea | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-Care Toolkit | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-Care Toolkit
- 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.
- interventionNames
- Other: Self-Care Toolkit
- type
- NO_INTERVENTION
- label
- Standard Care
- 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.
Primary outcomes (1)
- measure
- Change from preoperative in VAS General Anxiety at post-operative
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.