Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582971
• Other study ID #: 1R01CA157459-01
• Secondary ID: 1R01CA157459-01
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: March 20, 2018
• Start date: April 17, 2012
• Est. completion date: May 2016

Study information

• Verified date: March 2018
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: May 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Reflexology
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient

Locations

Country	Name	City	State
United States	Northwestern	Chicago	Illinois
United States	Hurley Medical Center	Flint	Michigan
United States	Lemmon-Holton Cancer Center	Grand Rapids	Michigan
United States	Breslin Cancer Center	Lansing	Michigan
United States	Sparrow Cancer Center	Lansing	Michigan
United States	McLaren Macomb	Mount Clemens	Michigan
United States	St. Joseph Mercy Oakland Hospital	Pontiac	Michigan
United States	Beaumont Hospital	Royal Oak	Michigan
United States	St. Johns Providence	Warren	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The M.D. Anderson Symptom Inventory (MDASI)	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.	Week 5 and week 11
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0	PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.; PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.; Higher scores representing better outcomes in each subscale.	Week 5 and week 11
Primary	Quality of Life Index (QLI)	The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.	Week 5 and week 11
Primary	Use of Unscheduled Health Service	Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.	Week 11