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Reflexology: An Intervention for Advanced Breast Cancer

Reflexology: An Intervention for Advanced Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01577420
Enrollment
451
Registered
2012-04-13
Start date
2005-08-31
Completion date
2010-08-31
Last updated
2012-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Reflexology, Breast Cancer, Complementary

Brief summary

The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III or IV) breast cancer within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.

Detailed description

The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and IV) breast cancer within the context of conventional medical care. This longitudinal randomized clinical trial (RCT) will test a three-group design in which participants will continue to receive conventional care. Two groups of the study will involve a single-blinded four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a certified reflexologist; Group B will receive placebo sessions from a research aide. The control group (Group C) will receive conventional medical care alone. The specific aims are: 1) to determine if women who receive either Groups (A or B) of an experimental protocol (reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone (Group C); 2) to determine if women who receive Group A of an experimental protocol (reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to determine if women who receive either Group A or B of an experimental protocol (reflexology or placebo), report significant differences on Intermediate Indicators (physical and emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone; and 4) to determine if the Intermediate Indicators mediate the group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of leading to an enhanced system of care through the integration of conventional and scientifically-based complementary therapies. It also focuses on advanced disease that is currently under investigation in terms of supportive care measures. Finally, this study utilizes an improved design over existing work. It is a RCT with adequate numbers to detect group differences, and could ultimately serve as a model for rigorous investigation of other complementary therapies.

Interventions

OTHERReflexology Sessions

One session per week performed by certified reflexologist for four consecutive weeks.

OTHERPlacebo Sessions

One session per week performed by research aide for four consecutive weeks.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of Stage III or IV breast cancer, or Stage I or II with Metastasis or Recurrence * Able to perform basic ADLs * Free of diagnosis of mental illness on chart * Able to speak and understand English * Access to a telephone * Receiving chemotherapy at intake into the study * Palliative Prognostic Score of 11 or lower * Oriented to time, place, and person as determined by nurse recruiter

Exclusion criteria

* Receiving investigational new drug chemotherapy * Receiving hospice care at intake * Living in nursing home or similar facility * Bedridden * Undergoing bone marrow transplant * Regularly using foot massage * Regularly using reflexology * Regularly using pedicure with foot massage

Design outcomes

Primary

MeasureTime frame
Health Related Quality of LifeBaseline to week 13

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026