Breast Cancer
Conditions
Keywords
Breast Cancer, Reflexology, Complementary
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 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 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.
Interventions
OTHERReflexology
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
Sponsors
National Cancer Institute (NCI)
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The M.D. Anderson Symptom Inventory (MDASI) | 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 | Week 5 and week 11 | 1. 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. 2. 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) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 128 |
| Control Standard medical care: no reflexology. | 128 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 18 | 21 |
| Overall Study | Other | 15 | 13 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 58.09 years STANDARD_DEVIATION 11.62 | 56.44 years STANDARD_DEVIATION 11.08 | 54.80 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 245 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 26 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) White | 105 Participants | 212 Participants | 107 Participants |
| Region of Enrollment United States | 128 Participants | 256 Participants | 128 Participants |
| Sex: Female, Male Female | 128 Participants | 256 Participants | 128 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 128 | 1 / 128 |
| other Total, other adverse events | 0 / 128 | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 | 0 / 128 |
Outcome results
Primary
Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
1. 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. 2. 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.
Time frame: Week 5 and week 11
Population: Participant outcome data collected at week 5 and week 11
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Week 5 Intervention Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Physical function subscale | 42.06 units on a scale | Standard Error 0.57 |
| Week 5 Intervention Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Social role subscale | 47.59 units on a scale | Standard Error 0.78 |
| Week 5 Control Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Social role subscale | 46.86 units on a scale | Standard Error 0.75 |
| Week 5 Control Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Physical function subscale | 41.81 units on a scale | Standard Error 0.55 |
| Week 11 Intervention Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Physical function subscale | 42.93 units on a scale | Standard Error 0.57 |
| Week 11 Intervention Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Social role subscale | 48.58 units on a scale | Standard Error 0.79 |
| Week 11 Control Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Physical function subscale | 42.80 units on a scale | Standard Error 0.56 |
| Week 11 Control Group | Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 | PROMIS-Social role subscale | 45.92 units on a scale | Standard Error 0.78 |
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.
Time frame: Week 5 and week 11
Population: Participant outcome data collected at week 5 and week 11
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Week 5 Intervention Group | Quality of Life Index (QLI) | 22.53 units on a scale | Standard Error 0.29 |
| Week 5 Control Group | Quality of Life Index (QLI) | 21.94 units on a scale | Standard Error 0.28 |
| Week 11 Intervention Group | Quality of Life Index (QLI) | 22.69 units on a scale | Standard Error 0.29 |
| Week 11 Control Group | Quality of Life Index (QLI) | 22.08 units on a scale | Standard Error 0.29 |
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.
Time frame: Week 5 and week 11
Population: Patient outcome data collected at week 5 and week 11
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Week 5 Intervention Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom severity | 23.55 units on a scale | Standard Error 1.52 |
| Week 5 Intervention Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom interference | 11.19 units on a scale | Standard Error 1.16 |
| Week 5 Control Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom interference | 16.04 units on a scale | Standard Error 1.12 |
| Week 5 Control Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom severity | 29.69 units on a scale | Standard Error 1.48 |
| Week 11 Intervention Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom severity | 26.28 units on a scale | Standard Error 1.54 |
| Week 11 Intervention Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom interference | 12.43 units on a scale | Standard Error 1.17 |
| Week 11 Control Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom severity | 28.67 units on a scale | Standard Error 1.52 |
| Week 11 Control Group | The M.D. Anderson Symptom Inventory (MDASI) | MDASI summed symptom interference | 14.88 units on a scale | Standard Error 1.16 |
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.
Time frame: Week 11
Population: Participant outcome data collected at week 11
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Week 5 Intervention Group | Use of Unscheduled Health Service | Number of emergency room visits | 0.27 unscheduled visits | Standard Deviation 0.78 |
| Week 5 Intervention Group | Use of Unscheduled Health Service | Number of urgent care center visits | 0.09 unscheduled visits | Standard Deviation 0.33 |
| Week 5 Intervention Group | Use of Unscheduled Health Service | Number of Hospitalizations | 0.76 unscheduled visits | Standard Deviation 1.19 |
| Week 5 Control Group | Use of Unscheduled Health Service | Number of emergency room visits | 0.65 unscheduled visits | Standard Deviation 2.85 |
| Week 5 Control Group | Use of Unscheduled Health Service | Number of urgent care center visits | 0.12 unscheduled visits | Standard Deviation 0.39 |
| Week 5 Control Group | Use of Unscheduled Health Service | Number of Hospitalizations | 1.05 unscheduled visits | Standard Deviation 0.61 |