Clinical trial · Interventional
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
NCT01582971CI-TRIAL-00032569completedN/AResults postedClinicalTrials.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)
The purpose of this project is to test foot reflexology delivered by a friend or family member in the home for women with breast cancer. The primary aims of the proposed study in a sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly reflexology sessions compared to an attention control group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reflexology | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
- interventionNames
- Other: Reflexology
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard medical care: no reflexology
Primary outcomes (4)
- measure
- The M.D. Anderson Symptom Inventory (MDASI)
- timeFrame
- Week 5 and week 11
- description
- The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived. Higher symptom severity and interference scores represent worse outcome.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 21 * Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence * Able to perform basic ADLs * Undergoing chemotherapy and/or hormonal therapy for breast cancer * Able to speak and understand English * Have access to a telephone * Able to hear normal conversation * Cognitively oriented to time, place, and person (determined via nurse recruiter) Exclusion Criteria: * Diagnosis of major mental illness on the medical record and verified by the recruiter * Residing in a nursing home * Bedridden * Currently receiving regular reflexology * Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval
References
Publications (2)
- DERIVEDSikorskii A, Niyogi PG, Victorson D, Tamkus D, Wyatt G. Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer. Support Care Cancer. 2020 Mar;28(3):1395-1404. doi: 10.1007/s00520-019-04959-y. Epub 2019 Jul 2. PMID 31267277
- DERIVEDLuo Z, Wang L, Sikorskii A, Wyatt G. Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women. Support Care Cancer. 2019 Aug;27(8):2837-2847. doi: 10.1007/s00520-018-4592-4. Epub 2018 Dec 14. PMID 30552595