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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA157459-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member |
|
| Control | No Intervention | Standard medical care: no reflexology |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology | Other | Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 |
Higher scores representing better outcomes in each subscale. | Week 5 and week 11 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwen Wyatt, PhD, RN | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern | Chicago | Illinois | 49201 | United States | ||
| Hurley Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31267277 | Derived | Sikorskii A, Niyogi PG, Victorson D, Tamkus D, Wyatt G. Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer. Support Care Cancer. 2020 Mar;28(3):1395-1404. doi: 10.1007/s00520-019-04959-y. Epub 2019 Jul 2. | |
| 30552595 | Derived | Luo Z, Wang L, Sikorskii A, Wyatt G. Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women. Support Care Cancer. 2019 Aug;27(8):2837-2847. doi: 10.1007/s00520-018-4592-4. Epub 2018 Dec 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member. Friend/family member was trained in foot reflexology protocol by certified reflexologist. Friend/family member provides 4 weekly sessions to patient. |
| FG001 | Control | Standard medical care: no reflexology. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member. Friend/family member was trained in foot reflexology protocol by certified reflexologist. Friend/family member provides 4 weekly sessions to patient. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patient outcome data collected at week 5 and week 11 | Posted | Least Squares Mean | Standard Error | units on a scale | Week 5 and week 11 |
|
Adverse events were tracked for unexpected foot effect at weeks 1-11
Adverse events were tracked from patient's report of the unexpected foot effect (UFE) which adapted from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) including discomfort, numbness or tingling, discoloration or bruising.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member. Friend/family member was trained in foot reflexology protocol by certified reflexologist. Friend/family member provides 4 weekly sessions to patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gwen Wyatt | Michigan State University | 517-432-5511 | gwyatt@msu.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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 |
| Flint |
| Michigan |
| 48503 |
| United States |
| Lemmon-Holton Cancer Center | Grand Rapids | Michigan | 49503 | United States |
| Breslin Cancer Center | Lansing | Michigan | 48910 | United States |
| Sparrow Cancer Center | Lansing | Michigan | 48912 | United States |
| McLaren Macomb | Mount Clemens | Michigan | 48043 | United States |
| St. Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48241 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| St. Johns Providence | Warren | Michigan | 48093 | United States |
| Withdrawal by Subject |
|
| Other |
|
Standard medical care: no reflexology. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Week 5 Intervention Group |
Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member. Friend/family member was trained in foot reflexology protocol by certified reflexologist. Friend/family member provides 4 weekly sessions to patient. |
| OG001 | Week 5 Control Group | Standard medical care: no reflexology |
| OG002 | Week 11 Intervention Group | Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member. Friend/family member was trained in foot reflexology protocol by certified reflexologist. Friend/family member provides 4 weekly sessions to patient. |
| OG003 | Week 11 Control Group | Standard medical care: no reflexology |
|
|
| Primary | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 |
Higher scores representing better outcomes in each subscale. | Participant outcome data collected at week 5 and week 11 | Posted | Least Squares Mean | Standard Error | units on a scale | 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. | Participant outcome data collected at week 5 and week 11 | Posted | Least Squares Mean | Standard Error | units on a scale | 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. | Participant outcome data collected at week 11 | Posted | Mean | Standard Deviation | unscheduled visits | Week 11 |
|
|
|
| 2 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | Control | Standard medical care: no reflexology | 1 | 128 | 0 | 128 | 0 | 128 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| PROMIS-Social role subscale |
|
| Number of Hospitalizations |
|