Clinical trial NCT01582971: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Official title: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Reflexology
Complementary
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-23
Enrollment: 256
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 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.

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

Primary outcomes:
measure: The M.D. Anderson Symptom Inventory (MDASI)
timeFrame: Week 5 and week 11
measure: Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
timeFrame: Week 5 and week 11
measure: Quality of Life Index (QLI)
timeFrame: Week 5 and week 11
measure: Use of Unscheduled Health Service
timeFrame: Week 11
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Lemmon-Holton Cancer Center
state: Michigan
city: Lansing
country: United States
facility: Breslin Cancer Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Warren
country: United States
facility: St. Johns Providence
state: Michigan
Study officials:
affiliation: Michigan State University
name: Gwen Wyatt, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sikorskii 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.
citation: Luo 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.