Cancer
Conditions
Brief summary
The purpose of this study is to compare reflexology to meditative practices to reduce symptoms in cancer patients.
Detailed description
First, dyads were randomized to receive caregiver-delivered reflexology or meditative practice. Fatigue severity was assesses weekly via phone calls to the cancer patients during weeks 1-4 of the intervention. For patients who did not respond to the intervention during the first 4 weeks, those dyads were referred to as non-responder and re-randomized. A non-responder was determined if the level of reported fatigue remained the same or increased from the first week of the intervention. The re-randomization placed the non-responders in either a group that received a higher dose (more time) with the first intervention or to the alternate practice (meditative practice to those randomized to reflexology and vice versa) for weeks 5-8. Those who did respond during weeks 1-4 continued the same therapy they began with.
Interventions
OTHERReflexology
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
OTHERMeditative Practices
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
Sponsors
National Cancer Institute (NCI)
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 21 year of age or older * Solid tumor cancer diagnosis * Able to perform basic activities of daily living (ADLs) * Undergoing chemotherapy, hormonal therapy, or targeted therapy * Able to speak and understand English * Have access to a telephone * Able to hear normal conversation * Reporting a severity of 3 or higher on fatigue using a 0-10 standardized scale at intake.
Exclusion criteria
* Diagnosis of major mental illness on the medical record (verified by the recruiter) * Residing in a nursing home * Bedridden * Currently receiving reflexology or meditative practices * Suspected or diagnosed deep vein thrombosis or painful foot neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The MD Anderson Symptom Inventory (MDASI)- Sadness | Weeks 1-4 | Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome |
| Brief Fatigue Inventory (BFI) | Week 1 -Week 4 | Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome |
| The MD Anderson Symptom Inventory (MDASI)- Distress | Weeks 1-4 | Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome |
| The MD Anderson Symptom Inventory (MDASI)- Summed Severity | Weeks 1-4 | Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory (BFI) | Weeks 5-12 | Aims 2 and 3: Average severity of fatigue for weeks 5-12 Score range: 0-10 Higher score means worse outcome |
| MD Anderson Symptom Inventory (MDASI)- Summed Severity | Weeks 5-12 | Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome |
| MD Anderson Symptom Inventory (MDASI)- Distress | Weeks 5-12 | Aims 2 and 3: Average severity of distress for weeks 5-12 Score range: 0-10 High score means worse outcome |
| MD Anderson Symptom Inventory (MDASI)- Sadness | Weeks 5-12 | Aims 2 and 3: Average severity of sadness for weeks 5-12 Score range: 0-10 High score means worse outcome |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 8 clinical centers between April 2015 and November 2019.
Pre-assignment details
Of the 471 consented, 347 completed the baseline interview and were randomized. Between the time of consent and baseline interview 124 dyads attrited. Reasons included: Changed mind about participating (n=24), cannot be reached via phone/mail (n=55), too busy (n=19), too overwhelmed (n=8), too sick (n=9) and other reasons (n=48). Throughout the study, if either patient or caregiver dropped from the study, the dyad was considered an attrition.
Participants by arm
| Arm | Count |
|---|---|
| Reflexology Patients Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms. | 150 |
| Meditative Practice Patients Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns | 150 |
| Control Patients Control- no intervention | 47 |
| Reflexology Caregivers Caregivers providing reflexology to their friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms. | 150 |
| Meditation Practice Caregivers Caregivers providing meditative practice to their friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns | 150 |
| Control Caregivers Control - no intervention | 47 |
| Total | 694 |
Baseline characteristics
| Characteristic | Reflexology Caregivers | Meditation Practice Caregivers | Total | Control Caregivers | Reflexology Patients | Control Patients | Meditative Practice Patients |
|---|---|---|---|---|---|---|---|
| Age, Customized Age- Caregiver | 56.07 years STANDARD_DEVIATION 14.84 | 55.56 years STANDARD_DEVIATION 14.58 | 55.65 years STANDARD_DEVIATION 14.5 | 54.59 years STANDARD_DEVIATION 13.42 | — | — | — |
| Age, Customized Age- Patient | — | — | 57.77 years STANDARD_DEVIATION 13.25 | — | 56.65 years STANDARD_DEVIATION 13.91 | 59.31 years STANDARD_DEVIATION 13.99 | 58.41 years STANDARD_DEVIATION 12.29 |
| Attentional function index Subscale 1 (action) | — | — | 6.08 units on a scale STANDARD_DEVIATION 2.2 | — | 6.08 units on a scale STANDARD_DEVIATION 2.22 | 5.71 units on a scale STANDARD_DEVIATION 2.45 | 6.19 units on a scale STANDARD_DEVIATION 2.11 |
| Attentional function index Subscale 2 (lapses) | — | — | 3.33 units on a scale STANDARD_DEVIATION 2.2 | — | 3.50 units on a scale STANDARD_DEVIATION 2.2 | 3.21 units on a scale STANDARD_DEVIATION 2.07 | 3.19 units on a scale STANDARD_DEVIATION 2.25 |
| Attentional function index Subscale 3 (effectiveness) | — | — | 5.95 units on a scale STANDARD_DEVIATION 1.73 | — | 5.93 units on a scale STANDARD_DEVIATION 1.71 | 5.70 units on a scale STANDARD_DEVIATION 1.93 | 6.04 units on a scale STANDARD_DEVIATION 1.67 |
| Brief Fatigue Inventory Severity of Fatigue (BFI, worst fatigue) | — | — | 3.99 units on a scale STANDARD_DEVIATION 2.78 | — | 4.08 units on a scale STANDARD_DEVIATION 2.9 | 3.81 units on a scale STANDARD_DEVIATION 2.63 | 3.95 units on a scale STANDARD_DEVIATION 2.71 |
| Caregiver burden Subscale 1 (impact) | 2.46 units on a scale STANDARD_DEVIATION 0.88 | 2.35 units on a scale STANDARD_DEVIATION 0.9 | 2.44 units on a scale STANDARD_DEVIATION 0.88 | 2.63 units on a scale STANDARD_DEVIATION 0.76 | — | — | — |
| Caregiver burden Subscale 2 (esteem) | 4.54 units on a scale STANDARD_DEVIATION 0.44 | 4.54 units on a scale STANDARD_DEVIATION 0.37 | 4.52 units on a scale STANDARD_DEVIATION 0.42 | 4.40 units on a scale STANDARD_DEVIATION 0.46 | — | — | — |
| Caregiver burden Subscale 3 (support) | 1.70 units on a scale STANDARD_DEVIATION 0.68 | 1.67 units on a scale STANDARD_DEVIATION 0.75 | 1.71 units on a scale STANDARD_DEVIATION 0.71 | 1.84 units on a scale STANDARD_DEVIATION 0.66 | — | — | — |
| Caregiver burden Subscale 4 (health) | 1.47 units on a scale STANDARD_DEVIATION 0.68 | 1.40 units on a scale STANDARD_DEVIATION 0.63 | 1.46 units on a scale STANDARD_DEVIATION 0.67 | 1.63 units on a scale STANDARD_DEVIATION 0.75 | — | — | — |
| Caregiver burden Subscale 5 (finance) | 1.95 units on a scale STANDARD_DEVIATION 0.89 | 1.83 units on a scale STANDARD_DEVIATION 0.84 | 1.88 units on a scale STANDARD_DEVIATION 0.86 | 1.82 units on a scale STANDARD_DEVIATION 0.83 | — | — | — |
| Education At least some college | 85 Participants | 81 Participants | 339 Participants | 28 Participants | 61 Participants | 22 Participants | 62 Participants |
| Education Graduate/ professional degree | 36 Participants | 49 Participants | 187 Participants | 13 Participants | 45 Participants | 11 Participants | 33 Participants |
| Education High school or less | 25 Participants | 18 Participants | 55 Participants | 6 Participants | 2 Participants | 0 Participants | 4 Participants |
| Employment Employed full time | 78 Participants | 67 Participants | 266 Participants | 18 Participants | 46 Participants | 13 Participants | 44 Participants |
| Employment Employed part time | 11 Participants | 15 Participants | 59 Participants | 5 Participants | 9 Participants | 4 Participants | 15 Participants |
| Employment Not employed | 14 Participants | 18 Participants | 232 Participants | 8 Participants | 83 Participants | 28 Participants | 81 Participants |
| Employment Retired | 42 Participants | 47 Participants | 122 Participants | 16 Participants | 9 Participants | 2 Participants | 6 Participants |
| Fatigue interference (BFI) | — | — | 21.12 units on a scale STANDARD_DEVIATION 15.4 | — | 20.14 units on a scale STANDARD_DEVIATION 15.09 | 21.91 units on a scale STANDARD_DEVIATION 14.08 | 21.85 units on a scale STANDARD_DEVIATION 16.14 |
| Income >=$100,000 | 24 Participants | 20 Participants | 107 Participants | 11 Participants | 17 Participants | 11 Participants | 24 Participants |
| Income <= $24,000 | 13 Participants | 9 Participants | 53 Participants | 4 Participants | 18 Participants | 1 Participants | 8 Participants |
| Income $25,000-$49,000 | 25 Participants | 23 Participants | 106 Participants | 7 Participants | 21 Participants | 5 Participants | 25 Participants |
| Income $50,000-$99,000 | 32 Participants | 42 Participants | 145 Participants | 6 Participants | 30 Participants | 7 Participants | 28 Participants |
| Income Other | 40 Participants | 43 Participants | 243 Participants | 15 Participants | 60 Participants | 22 Participants | 63 Participants |
| Living arrangement Separately | 42 Participants | 35 Participants | 180 Participants | 13 Participants | 42 Participants | 13 Participants | 35 Participants |
| Living arrangement Together | 100 Participants | 112 Participants | 492 Participants | 34 Participants | 100 Participants | 34 Participants | 112 Participants |
| Long Term Quality of Life (LTQL) spirituality | — | — | 33.85 units on a scale STANDARD_DEVIATION 7.99 | — | 34.27 units on a scale STANDARD_DEVIATION 8.56 | 33.26 units on a scale STANDARD_DEVIATION 8.33 | 33.63 units on a scale STANDARD_DEVIATION 7.3 |
| Number of comorbid conditions Comorbid conditions- caregiver | 3.45 Number of conditions STANDARD_DEVIATION 2.56 | 2.93 Number of conditions STANDARD_DEVIATION 2.71 | 3.17 Number of conditions STANDARD_DEVIATION 2.63 | 3.06 Number of conditions STANDARD_DEVIATION 2.54 | — | — | — |
| Number of comorbid conditions Comorbid conditions- patient | — | — | 3.90 Number of conditions STANDARD_DEVIATION 2.86 | — | 3.89 Number of conditions STANDARD_DEVIATION 2.83 | 4.19 Number of conditions STANDARD_DEVIATION 3.35 | 3.83 Number of conditions STANDARD_DEVIATION 2.73 |
| Number of Complimentary and Alternative Medicine (CAM) therapies used | — | — | 2.38 Number of CAM therapies STANDARD_DEVIATION 2.27 | — | 2.36 Number of CAM therapies STANDARD_DEVIATION 2.41 | 2.00 Number of CAM therapies STANDARD_DEVIATION 1.91 | 2.51 Number of CAM therapies STANDARD_DEVIATION 2.23 |
| Patient-caregiver relationship Adult Child | 15 Participants | 16 Participants | 66 Participants | 7 Participants | 14 Participants | 3 Participants | 11 Participants |
| Patient-caregiver relationship Friend | 19 Participants | 17 Participants | 82 Participants | 5 Participants | 19 Participants | 5 Participants | 17 Participants |
| Patient-caregiver relationship Other | 12 Participants | 9 Participants | 46 Participants | 2 Participants | 12 Participants | 2 Participants | 9 Participants |
| Patient-caregiver relationship Parent | 14 Participants | 11 Participants | 66 Participants | 3 Participants | 15 Participants | 7 Participants | 16 Participants |
| Patient-caregiver relationship Spouse | 85 Participants | 94 Participants | 418 Participants | 30 Participants | 85 Participants | 30 Participants | 94 Participants |
| Patient Reported Outcomes Measurement Information System (PROMIS) depression PROMIS depression- Caregiver | 47.14 units on a scale STANDARD_DEVIATION 7.61 | 45.41 units on a scale STANDARD_DEVIATION 6.45 | 46.35 units on a scale STANDARD_DEVIATION 7.19 | 46.87 units on a scale STANDARD_DEVIATION 7.82 | — | — | — |
| Patient Reported Outcomes Measurement Information System (PROMIS) depression PROMIS depression- Patient | — | — | 53.65 units on a scale STANDARD_DEVIATION 8.39 | — | 53.67 units on a scale STANDARD_DEVIATION 8.52 | 55.26 units on a scale STANDARD_DEVIATION 7.98 | 53.13 units on a scale STANDARD_DEVIATION 8.39 |
| PROMIS anxiety PROMIS anxiety- Caregiver | 48.38 units on a scale STANDARD_DEVIATION 8.31 | 46.09 units on a scale STANDARD_DEVIATION 7.67 | 47.35 units on a scale STANDARD_DEVIATION 8.26 | 48.10 units on a scale STANDARD_DEVIATION 9.43 | — | — | — |
| PROMIS anxiety PROMIS anxiety- Patient | — | — | 54.13 units on a scale STANDARD_DEVIATION 8.76 | — | 54.34 units on a scale STANDARD_DEVIATION 9.17 | 55.01 units on a scale STANDARD_DEVIATION 7.78 | 53.64 units on a scale STANDARD_DEVIATION 8.66 |
| PROMIS fatigue | 47.10 units on a scale STANDARD_DEVIATION 9.03 | 45.40 units on a scale STANDARD_DEVIATION 8.57 | 46.55 units on a scale STANDARD_DEVIATION 8.99 | 48.43 units on a scale STANDARD_DEVIATION 9.78 | — | — | — |
| PROMIS- Fatigue Number | 2.29 units on a scale STANDARD_DEVIATION 1.07 | 2.02 units on a scale STANDARD_DEVIATION 1 | 2.18 units on a scale STANDARD_DEVIATION 1.06 | 2.38 units on a scale STANDARD_DEVIATION 1.17 | — | — | — |
| PROMIS pain intensity | 1.51 units on a scale STANDARD_DEVIATION 1.86 | 1.29 units on a scale STANDARD_DEVIATION 1.84 | 1.43 units on a scale STANDARD_DEVIATION 1.86 | 1.64 units on a scale STANDARD_DEVIATION 1.94 | — | — | — |
| PROMIS pain interference | 47.59 units on a scale STANDARD_DEVIATION 7.67 | 47.18 units on a scale STANDARD_DEVIATION 7.85 | 47.65 units on a scale STANDARD_DEVIATION 7.91 | 49.28 units on a scale STANDARD_DEVIATION 8.75 | — | — | — |
| PROMIS physical function PROMIS physical function- Caregiver | 54.00 units on a scale STANDARD_DEVIATION 6.03 | 53.33 units on a scale STANDARD_DEVIATION 6.74 | 53.49 units on a scale STANDARD_DEVIATION 6.73 | 52.40 units on a scale STANDARD_DEVIATION 8.54 | — | — | — |
| PROMIS physical function PROMIS physical function- Patient | — | — | 40.05 units on a scale STANDARD_DEVIATION 8.1 | — | 39.97 units on a scale STANDARD_DEVIATION 7.99 | 39.91 units on a scale STANDARD_DEVIATION 7.01 | 40.17 units on a scale STANDARD_DEVIATION 8.58 |
| PROMIS sleep disturbance | 47.09 units on a scale STANDARD_DEVIATION 7.18 | 46.29 units on a scale STANDARD_DEVIATION 8.27 | 46.85 units on a scale STANDARD_DEVIATION 7.75 | 47.86 units on a scale STANDARD_DEVIATION 7.8 | — | — | — |
| Race/Ethnicity, Customized Ethnicity Hispanic | 17 Participants | 7 Participants | 60 Participants | 3 Participants | 23 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnicity Non Hispanic | 126 Participants | 139 Participants | 614 Participants | 44 Participants | 122 Participants | 43 Participants | 140 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants | 1 Participants | 6 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 5 Participants | 23 Participants | 4 Participants | 7 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 8 Participants | 12 Participants | 44 Participants | 0 Participants | 12 Participants | 0 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 9 Participants | 32 Participants | 3 Participants | 5 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White Caucasian | 119 Participants | 119 Participants | 579 Participants | 40 Participants | 126 Participants | 46 Participants | 129 Participants |
| Satisfaction with participation in social roles | 54.63 units on a scale STANDARD_DEVIATION 8.69 | 55.94 units on a scale STANDARD_DEVIATION 7.92 | 55.00 units on a scale STANDARD_DEVIATION 8.47 | 53.15 units on a scale STANDARD_DEVIATION 9.23 | — | — | — |
| Sex: Female, Male Female | 84 Participants | 76 Participants | 451 Participants | 26 Participants | 116 Participants | 34 Participants | 115 Participants |
| Sex: Female, Male Male | 56 Participants | 61 Participants | 218 Participants | 19 Participants | 34 Participants | 13 Participants | 35 Participants |
| Social Support (MSPSS) | — | — | 26.09 units on a scale STANDARD_DEVIATION 4.18 | — | 25.93 units on a scale STANDARD_DEVIATION 4.46 | 25.64 units on a scale STANDARD_DEVIATION 3.07 | 26.40 units on a scale STANDARD_DEVIATION 4.19 |
| Summed severity of other symptoms (MDASI) | — | — | 39.20 units on a scale STANDARD_DEVIATION 27.81 | — | 38.61 units on a scale STANDARD_DEVIATION 29 | 37.23 units on a scale STANDARD_DEVIATION 22.46 | 40.43 units on a scale STANDARD_DEVIATION 28.24 |
| Symptom interference (MDASI) | — | — | 19.32 units on a scale STANDARD_DEVIATION 15.3 | — | 19.06 units on a scale STANDARD_DEVIATION 15.46 | 18.98 units on a scale STANDARD_DEVIATION 14.91 | 19.69 units on a scale STANDARD_DEVIATION 15.35 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 150 | 5 / 150 | 0 / 47 |
| other Total, other adverse events | 0 / 150 | 0 / 150 | 0 / 47 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 | 0 / 47 |
Outcome results
Primary
Brief Fatigue Inventory (BFI)
Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Time frame: Week 1 -Week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | Brief Fatigue Inventory (BFI) | 4.17 units on a scale | Standard Error 0.17 |
| Meditative Practice Patients | Brief Fatigue Inventory (BFI) | 4.08 units on a scale | Standard Error 0.18 |
| Control Patients | Brief Fatigue Inventory (BFI) | 4.32 units on a scale | Standard Error 0.26 |
Comparison: Aim 1: Comparing reflexology vs meditative practice for weeks 1-4p-value: 0.7295% CI: [-0.36, 0.52]Mixed Models Analysis
Comparison: Aim 1: Comparing reflexology vs control for weeks 1-4p-value: 0.5895% CI: [-0.72, 0.41]Mixed Models Analysis
Comparison: Aim 1: Comparing meditative practices vs control for weeks 1-4p-value: 0.4295% CI: [-0.81, 0.34]Mixed Models Analysis
Primary
The MD Anderson Symptom Inventory (MDASI)- Distress
Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Time frame: Weeks 1-4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | The MD Anderson Symptom Inventory (MDASI)- Distress | 2.20 units on a scale | Standard Error 0.17 |
| Meditative Practice Patients | The MD Anderson Symptom Inventory (MDASI)- Distress | 2.21 units on a scale | Standard Error 0.17 |
| Control Patients | The MD Anderson Symptom Inventory (MDASI)- Distress | 2.40 units on a scale | Standard Error 0.25 |
Comparison: Aim 1: Comparing reflexology vs meditative practice for weeks 1-4p-value: 0.9695% CI: [-0.44, 0.42]Mixed Models Analysis
Comparison: Aim 1: Comparing reflexology vs control for weeks 1-4p-value: 0.4895% CI: [-0.75, 0.35]Mixed Models Analysis
Comparison: Aim 1: Comparing meditative practice vs control for weeks 1-4p-value: 0.5295% CI: [-0.75, 0.38]Mixed Models Analysis
Primary
The MD Anderson Symptom Inventory (MDASI)- Sadness
Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome
Time frame: Weeks 1-4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | The MD Anderson Symptom Inventory (MDASI)- Sadness | 1.79 units on a scale | Standard Error 0.15 |
| Meditative Practice Patients | The MD Anderson Symptom Inventory (MDASI)- Sadness | 1.78 units on a scale | Standard Error 0.16 |
| Control Patients | The MD Anderson Symptom Inventory (MDASI)- Sadness | 2.03 units on a scale | Standard Error 0.23 |
Comparison: Aim 1: Comparing reflexology vs meditative practice for weeks 1-4p-value: 0.9895% CI: [-0.38, 0.39]Mixed Models Analysis
Comparison: Aim 1: Comparing reflexology vs control for weeks 1-4p-value: 0.3495% CI: [-0.74, 0.25]Mixed Models Analysis
Comparison: Aim 1: Comparing meditative practices vs control for weeks 1-4p-value: 0.3495% CI: [-0.76, 0.26]Mixed Models Analysis
Primary
The MD Anderson Symptom Inventory (MDASI)- Summed Severity
Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome
Time frame: Weeks 1-4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | The MD Anderson Symptom Inventory (MDASI)- Summed Severity | 29.99 units on a scale | Standard Error 1.27 |
| Meditative Practice Patients | The MD Anderson Symptom Inventory (MDASI)- Summed Severity | 29.32 units on a scale | Standard Error 1.3 |
| Control Patients | The MD Anderson Symptom Inventory (MDASI)- Summed Severity | 32.52 units on a scale | Standard Error 1.87 |
Comparison: Aim 1: Comparing reflexology vs meditative practice for weeks 1-4p-value: 0.6895% CI: [-2.52, 3.86]Mixed Models Analysis
Comparison: Aim 1: Comparing reflexology vs control for weeks 1-4p-value: 0.2395% CI: [-6.64, 1.58]Mixed Models Analysis
Comparison: Aim 1: Comparing meditative practice vs control for weeks 1-4p-value: 0.1495% CI: [-7.41, 1.01]Mixed Models Analysis
Secondary
Brief Fatigue Inventory (BFI)
Aim 4: Average severity of fatigue for weeks 5-12 across initial 3 arms of study. The BFI instrument consists of nine items. The first three items ask respondents to rate the severity of fatigue right now, at its usual level during the past 24 hours and at its worst level during the past 24 hours. Score range: 0-10 where 0 = no fatigue and 10 = as bad as you can imagine Higher score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | Brief Fatigue Inventory (BFI) | 3.62 units on a scale | Standard Error 0.21 |
| Meditative Practice Patients | Brief Fatigue Inventory (BFI) | 3.53 units on a scale | Standard Error 0.21 |
| Control Patients | Brief Fatigue Inventory (BFI) | 3.87 units on a scale | Standard Error 0.28 |
Comparison: Aim 4: Comparing reflexology vs control for weeks 5-12p-value: 0.4295% CI: [-0.88, 0.37]Mixed Models Analysis
Comparison: Aim 4: Comparing meditative practices vs control for weeks 5-12p-value: 0.2995% CI: [-0.98, 0.29]Mixed Models Analysis
Secondary
Brief Fatigue Inventory (BFI)
Aims 2 and 3: Average severity of fatigue for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | Brief Fatigue Inventory (BFI) | 3.74 units on a scale | Standard Error 0.38 |
| Meditative Practice Patients | Brief Fatigue Inventory (BFI) | 3.99 units on a scale | Standard Error 0.35 |
| Control Patients | Brief Fatigue Inventory (BFI) | 4.52 units on a scale | Standard Error 0.52 |
| Meditative Practice, Continuing With Meditative Practice | Brief Fatigue Inventory (BFI) | 4.03 units on a scale | Standard Error 0.42 |
Comparison: Aim 2: After 4 weeks of reflexology, comparing continuing reflexology vs adding meditative practicep-value: 0.5795% CI: [-0.63, 1.14]Mixed Models Analysis
Comparison: Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12p-value: 0.3995% CI: [-0.64, 1.63]Mixed Models Analysis
Secondary
MD Anderson Symptom Inventory (MDASI)- Distress
Aim 4: Average severity of distress for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | MD Anderson Symptom Inventory (MDASI)- Distress | 1.78 units on a scale | Standard Error 0.19 |
| Meditative Practice Patients | MD Anderson Symptom Inventory (MDASI)- Distress | 2.00 units on a scale | Standard Error 0.2 |
| Control Patients | MD Anderson Symptom Inventory (MDASI)- Distress | 2.20 units on a scale | Standard Error 0.26 |
Comparison: Aim 4: Comparing reflexology vs control for weeks 5-12p-value: 0.1595% CI: [-1, 0.15]Mixed Models Analysis
Comparison: Aim 4: Comparing meditative practice vs control for weeks 5-12p-value: 0.595% CI: [-0.8, 0.39]Mixed Models Analysis
Secondary
MD Anderson Symptom Inventory (MDASI)- Distress
Aims 2 and 3: Average severity of distress for weeks 5-12 Score range: 0-10 High score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | MD Anderson Symptom Inventory (MDASI)- Distress | 2.28 units on a scale | Standard Error 0.33 |
| Meditative Practice Patients | MD Anderson Symptom Inventory (MDASI)- Distress | 2.09 units on a scale | Standard Error 0.3 |
| Control Patients | MD Anderson Symptom Inventory (MDASI)- Distress | 2.11 units on a scale | Standard Error 0.56 |
| Meditative Practice, Continuing With Meditative Practice | MD Anderson Symptom Inventory (MDASI)- Distress | 2.07 units on a scale | Standard Error 0.48 |
Comparison: Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12p-value: 0.6295% CI: [-0.95, 0.57]Mixed Models Analysis
Comparison: Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12p-value: 0.9595% CI: [-1.15, 1.22]Mixed Models Analysis
Secondary
MD Anderson Symptom Inventory (MDASI)- Sadness
Aims 2 and 3: Average severity of sadness for weeks 5-12 Score range: 0-10 High score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | MD Anderson Symptom Inventory (MDASI)- Sadness | 2.17 units on a scale | Standard Error 0.4 |
| Meditative Practice Patients | MD Anderson Symptom Inventory (MDASI)- Sadness | 2.03 units on a scale | Standard Error 0.36 |
| Control Patients | MD Anderson Symptom Inventory (MDASI)- Sadness | 2.01 units on a scale | Standard Error 0.47 |
| Meditative Practice, Continuing With Meditative Practice | MD Anderson Symptom Inventory (MDASI)- Sadness | 2.23 units on a scale | Standard Error 0.38 |
Comparison: Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice for weeks 5-12p-value: 0.7795% CI: [-1.04, 0.77]Mixed Models Analysis
Comparison: Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12p-value: 0.6795% CI: [-1.23, 0.8]Mixed Models Analysis
Secondary
MD Anderson Symptom Inventory (MDASI)- Sadness
Aim 4: Average severity of sadness for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | MD Anderson Symptom Inventory (MDASI)- Sadness | 1.75 units on a scale | Standard Error 0.18 |
| Meditative Practice Patients | MD Anderson Symptom Inventory (MDASI)- Sadness | 1.66 units on a scale | Standard Error 0.19 |
| Control Patients | MD Anderson Symptom Inventory (MDASI)- Sadness | 2.02 units on a scale | Standard Error 0.25 |
Comparison: Aim 4: Comparing reflexology vs control for weeks 5-12p-value: 0.3395% CI: [-0.83, 0.28]Mixed Models Analysis
Comparison: Aim 4: Comparing meditative practice vs control for weeks 5-12p-value: 0.2295% CI: [-0.93, 0.21]Mixed Models Analysis
Secondary
MD Anderson Symptom Inventory (MDASI)- Summed Severity
Aim 4: Comparing average severity of symptoms for weeks 5-12 Summed score range: 0-180 Higher score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 26.69 units on a scale | Standard Error 1.66 |
| Meditative Practice Patients | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 25.77 units on a scale | Standard Error 1.7 |
| Control Patients | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 30.25 units on a scale | Standard Error 2.28 |
Comparison: Aim 4: Comparing reflexology vs control for weeks 5-12p-value: 0.1795% CI: [-8.62, 1.52]Mixed Models Analysis
Comparison: Aim 4: Comparing meditative practice vs control for weeks 5-12p-value: 0.0995% CI: [-9.66, 0.7]Mixed Models Analysis
Secondary
MD Anderson Symptom Inventory (MDASI)- Summed Severity
Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome
Time frame: Weeks 5-12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reflexology Patients | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 29.96 units on a scale | Standard Error 3.97 |
| Meditative Practice Patients | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 28.02 units on a scale | Standard Error 3.57 |
| Control Patients | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 32.18 units on a scale | Standard Error 3.76 |
| Meditative Practice, Continuing With Meditative Practice | MD Anderson Symptom Inventory (MDASI)- Summed Severity | 30.33 units on a scale | Standard Error 3.04 |
Comparison: Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12p-value: 0.6795% CI: [-10.93, 7.04]Mixed Models Analysis
Comparison: Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12p-value: 0.6695% CI: [-6.59, 10.29]Mixed Models Analysis