Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01582971|
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : October 2, 2017
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Reflexology||Not Applicable|
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:
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home-Based Symptom Management Via Reflexology for Breast Cancer Patients|
|Study Start Date :||April 17, 2012|
|Actual Primary Completion Date :||May 1, 2016|
|Actual Study Completion Date :||May 2016|
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
- The M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: Week 5 and week 11 ]
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.
- Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 [ Time Frame: Week 5 and week 11 ]
- 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.
- Quality of Life Index (QLI) [ Time Frame: Week 5 and week 11 ]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.
- Use of Unscheduled Health Service [ Time Frame: Week 11 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582971
|United States, Illinois|
|Chicago, Illinois, United States, 49201|
|United States, Michigan|
|Hurley Medical Center|
|Flint, Michigan, United States, 48503|
|Lemmon-Holton Cancer Center|
|Grand Rapids, Michigan, United States, 49503|
|Breslin Cancer Center|
|Lansing, Michigan, United States, 48910|
|Sparrow Cancer Center|
|Lansing, Michigan, United States, 48912|
|Mount Clemens, Michigan, United States, 48043|
|St. Joseph Mercy Oakland Hospital|
|Pontiac, Michigan, United States, 48241|
|Royal Oak, Michigan, United States, 48073|
|St. Johns Providence|
|Warren, Michigan, United States, 48093|
|Principal Investigator:||Gwen Wyatt, PhD, RN||Michigan State University|