Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Home-Based Symptom Management Via Reflexology for Breast Cancer Patients|
- Health Related Quality of Life [ Time Frame: 11 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
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
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:
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582971
|Contact: Gwen Wyatt, PhD, RNfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 49201|
|United States, Michigan|
|Hurley Medical Center||Recruiting|
|Flint, Michigan, United States, 48503|
|Lemmon-Holton Cancer Center||Not yet recruiting|
|Grand Rapids, Michigan, United States, 49503|
|Breslin Cancer Center||Recruiting|
|Lansing, Michigan, United States, 48910|
|Sparrow Cancer Center||Recruiting|
|Lansing, Michigan, United States, 48912|
|Mt. Clemens, Michigan, United States, 48043|
|St. Joseph Mercy Oakland Hospital||Recruiting|
|Pontiac, Michigan, United States, 48241|
|Royal Oak, Michigan, United States, 48073|
|St. Johns Providence||Recruiting|
|Warren, Michigan, United States, 48093|
|Principal Investigator:||Gwen Wyatt, PhD, RN||Michigan State University|