N/A
N=256
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01582971 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: The M.D. Anderson Symptom Inventory (MDASI) — 23.55; 29.69; 26.28; 28.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reflexology (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Michigan State University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The M.D. Anderson Symptom Inventory (MDASI) |
23.55; 29.69; 26.28; 28.67; 11.19; 16.04 | — |
| PRIMARY Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 |
42.06; 41.81; 42.93; 42.80; 47.59; 46.86 | — |
| PRIMARY Quality of Life Index (QLI) |
22.53; 21.94; 22.69; 22.08 | — |
| PRIMARY Use of Unscheduled Health Service |
0.27; 0.65; 0.09; 0.12; 0.76; 1.05 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01582971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.