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History of Changes for Study: NCT01582971
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Latest version (submitted March 20, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 19, 2012 None (earliest Version on record)
2 June 24, 2013 Contacts/Locations and Study Status
3 April 2, 2014 Contacts/Locations and Study Status
4 April 6, 2015 Study Status
5 March 15, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 April 28, 2016 Study Status
7 August 15, 2017 Study Status, Outcome Measures, Study Description, Results, IPDSharing, Contacts/Locations and Study Design
8 October 5, 2017 Study Status, Outcome Measures
9 March 20, 2018 Recruitment Status and Study Status
Comparison Format:

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Study NCT01582971
Submitted Date:  April 19, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1R01CA157459-01
Brief Title: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Official Title: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Secondary IDs: 1R01CA157459-01 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Recruiting
Study Start: May 2011
Primary Completion: March 2015 [Anticipated]
Study Completion: March 2016 [Anticipated]
First Submitted: April 17, 2012
First Submitted that
Met QC Criteria:
April 19, 2012
First Posted: April 23, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 19, 2012
Last Update Posted: April 23, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Michigan State University
Responsible Party: Principal Investigator
Investigator: Gwen Wyatt
Official Title: Professor
Affiliation: Michigan State University
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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 (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.
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 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.

Open or close this module Conditions
Conditions: Breast Cancer
Keywords: Breast Cancer
Reflexology
Complementary
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 268 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Intervention
Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
Reflexology
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
No Intervention: Control
Standard medical care: no reflexology
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Health Related Quality of Life
[ Time Frame: 11 Weeks ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Gwen Wyatt, PhD, RN
Telephone: 517-432-5511
Email: Tara.miller@hc.msu.edu
Study Officials: Gwen Wyatt, PhD, RN
Principal Investigator
Michigan State University
Locations: United States, Illinois
Northwestern
[Recruiting]
Chicago, Illinois, United States, 49201
United States, Michigan
Hurley Medical Center
[Not yet recruiting]
Flint, Michigan, United States, 48503
Lemmon-Holton Cancer Center
[Not yet recruiting]
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care
[Not yet recruiting]
Grand Rapids, Michigan, United States, 49503
Allegiance Health
[Not yet recruiting]
Jackson, Michigan, United States, 49201
Breslin Cancer Center
[Recruiting]
Lansing, Michigan, United States, 48910
Sparrow Cancer Center
[Recruiting]
Lansing, Michigan, United States, 48912
Memorial Healthcare
[Not yet recruiting]
Owosso, Michigan, United States, 48867
St. Joseph Mercy Oakland Hospital
[Not yet recruiting]
Pontiac, Michigan, United States, 48241
Beaumont Hospital
[Not yet recruiting]
Royal Oak, Michigan, United States, 48073
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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