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Home-Based Symptom Management Via Reflexology for Breast Cancer Patients


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Home-Based Symptom Management Via Reflexology for Breast Cancer Patients


This project tests the benefits of a home-based intervention of foot reflexology for
improving health-related quality of life (HRQOL) including symptom responses, functioning,
and health perceptions in women treated with chemotherapy for advanced breast cancer.
Reflexology applies a firm walking-motion during sessions and is based on the premise that
the foot has reflexes mirroring organs of the body. Symptom burden is the strongest
predictor of HRQOL for cancer patients. This project brings together expertise from nursing,
reflexology, communication, statistics, and health economics. The primary specific aims, in
a sample of 200 women with advanced breast cancer receiving chemotherapy, are to determine
the effects of a 4-week, home-based reflexology intervention delivered by a friend/family
provider compared to attention control for improvement of:

1. HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11.

The investigators hypothesize that the reflexology group will have better HRQOL
(symptoms, functioning, and health perception) than the attention control group at
study weeks 5 and 11.

2. Multiple symptom responses and times-to-response as determined by weekly symptom
assessments during the 4-week intervention time.

The investigators hypothesize that the reflexology group will have a higher proportion
of symptoms that respond to the intervention and shorter time-to-symptom-responses than
the attention control group.

3. Symptom-related use of unscheduled health services during the 11-week study. The
investigators hypothesize that fewer unscheduled services will be used for symptom
management over the 11-week study period by women receiving reflexology compared to
women in the attention control.

The exploratory aims are to: 1) Explore differences between trial arms in perceptions of
social support due to the family- or friend-delivered reflexology sessions at study weeks 5
and 11; 2) Determine if effects of the reflexology intervention on HRQOL are mediated by
social support; and 3) Use the newly developed NIH PROMIS standardized symptom and
functioning instruments to assess the effects of the reflexology intervention and to compare
the responsiveness of PROMIS instruments and existing instruments designed to measure
similar constructs.

This project has immense potential to make an effective symptom management intervention
accessible to patients in their homes via a friend or family home provider. The
investigators will not only intervene to enhance HRQOL but also to evaluate social support
and costs associated with unscheduled health services. Effective symptom management provides
time and cost savings to clinicians, advances the current state-of-the-science, and promotes
adherence to medical treatment that may ultimately enhance survival.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Health Related Quality of Life

Outcome Time Frame:

11 Weeks

Safety Issue:

No

Principal Investigator

Gwen Wyatt, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michigan State University

Authority:

United States: Institutional Review Board

Study ID:

1R01CA157459-01

NCT ID:

NCT01582971

Start Date:

May 2011

Completion Date:

March 2016

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Reflexology
  • Complementary
  • Breast Neoplasms

Name

Location

Hurley Medical CenterFlint, Michigan  48503
St. Joseph Mercy Oakland HospitalPontiac, Michigan  33308
Sparrow Cancer CenterLansing, Michigan  48912
Breslin Cancer CenterLansing, Michigan  48910
Beaumont HospitalRoyal Oak, Michigan  48073
NorthwesternChicago, Illinois  49201
Lemmon-Holton Cancer CenterGrand Rapids, Michigan  49503
McLaren MacombMount Clemens, Michigan  48043
St. Johns ProvidenceWarren, Michigan  48093