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Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Michigan State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University
ClinicalTrials.gov Identifier:
NCT01582971
First received: April 17, 2012
Last updated: April 2, 2014
Last verified: April 2014

April 17, 2012
April 2, 2014
May 2011
March 2015   (final data collection date for primary outcome measure)
Health Related Quality of Life [ Time Frame: 11 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01582971 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

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 (post-attrition n=200) 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Other: Reflexology
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
  • Experimental: Intervention
    Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
    Intervention: Other: Reflexology
  • No Intervention: Control
    Standard medical care: no reflexology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
268
March 2016
March 2015   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact: Gwen Wyatt, PhD, RN 517-432-5511 allison.thorp@hc.msu.edu
United States
 
NCT01582971
1R01CA157459-01, 1R01CA157459-01
Yes
Gwen Wyatt, Michigan State University
Michigan State University
National Cancer Institute (NCI)
Principal Investigator: Gwen Wyatt, PhD, RN Michigan State University
Michigan State University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP