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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA193706 | 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 study is to compare reflexology to meditative practices to reduce symptoms in cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflexology | Experimental | 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. |
|
| Meditative Practice | Experimental | 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 |
|
| Control | No Intervention | Control - no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Fatigue Inventory (BFI) | Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome | Week 1 -Week 4 |
| 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 | Weeks 1-4 |
| 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 | Weeks 1-4 |
| 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 | Weeks 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 5-12 |
| MD Anderson Symptom Inventory (MDASI)- Summed Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwen Wyatt, PhD, RN | Michigan State University College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Tucson | Arizona | 85704 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35378595 | Derived | Thana K, Sikorskii A, Lehto R, Guhaniyogi P, Brewer S, Victorson D, Pace T, Badger T, Wyatt G. Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial. Support Care Cancer. 2022 Jul;30(7):5891-5902. doi: 10.1007/s00520-022-07012-7. Epub 2022 Apr 5. |
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Findings from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings.
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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 were recruited from 8 clinical centers between April 2015 and November 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reflexology With Response, Then Continued Reflexology | 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. Participants were randomized into the reflexology intervention, then after week 4 of symptom responses, were considered responders. Participants then continued with the reflexology intervention. |
| FG001 | Reflexology Non-responders, Then Continued Reflexology | 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. Participants were randomized into the reflexology intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then continued with the reflexology intervention. |
| FG002 | Reflexology Non-responders, Then Switch to Meditation | 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. 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. Participants were randomized into the reflexology intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then switched to a meditative practice intervention. |
| FG003 | Control | Control - no intervention |
| FG004 | Meditative Practice With Response, Continued Meditation | 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. Participants were randomized into the meditative practice intervention, then after 4 weeks of symptom response were considered responders. Participants then continued with the meditative practice intervention. |
| FG005 | Meditative Practice Non-responders, Continued Meditation | 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. Participants were randomized into the mindfulness meditation intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then continued with the meditative practice intervention. |
| FG006 | Meditative Practice Non-responders, Switch to Reflexology | 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. 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. Participants were randomized into the meditative practice intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then switched to a reflexology intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1-4 |
| |||||||||||||
| Week 5-8 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Baseline measure separated by patient/ caregiver |
| 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 | Brief Fatigue Inventory (BFI) | Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome | Posted | Least Squares Mean | Standard Error | units on a scale | Week 1 -Week 4 |
|
Data was collected over 12 weeks
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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 | Reflexology | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gwen Wyatt | Michigan State University | 517-353-6672 | gwyatt@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2020 | May 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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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| Meditative Practices | Other | 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 |
|
Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome
| Weeks 5-12 |
| 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 | Weeks 5-12 |
| 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 | Weeks 5-12 |
| 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 | Weeks 5-12 |
| 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 | Weeks 5-12 |
| 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 | Weeks 5-12 |
| 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 | Weeks 5-12 |
| Tucson |
| Arizona |
| 85721 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | United States |
| MSU Breslin Cancer Center | Lansing | Michigan | 48910 | United States |
| Sparrow Cancer Center | Lansing | Michigan | 48912 | United States |
| COMPLETED | In the reflexology and meditative practices groups created by the first randomization, one participant could not continue without the other at week 5 unless the patient was a responder and dyad was not re-randomized. |
|
| NOT COMPLETED |
|
| BG001 |
| 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 |
| BG002 | Control Patients | Control- no intervention |
| BG003 | 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. |
| BG004 | 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 |
| BG005 | Control Caregivers | Control - no intervention |
| BG006 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Baseline measure separated by patient/ caregiver | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Participant did not respond | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participant did not respond | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participant did not respond | Count of Participants | Participants |
|
| Number of comorbid conditions | Not all participants responded to question | Mean | Standard Deviation | Number of conditions |
|
| Patient-caregiver relationship | Participant did not respond | Count of Participants | Participants |
|
| Living arrangement | Not all patients/ caregivers responded | Count of Participants | Participants |
|
| Number of Complimentary and Alternative Medicine (CAM) therapies used | Participants did not respond | Mean | Standard Deviation | Number of CAM therapies |
|
| Education | Count of Participants | Participants |
|
| Employment | Participant did not respond | Count of Participants | Participants |
|
| Income | Participant did not respond | Count of Participants | Participants |
|
| Brief Fatigue Inventory Severity of Fatigue (BFI, worst fatigue) | 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. Answer choices are on a scale of 0 -10, where 0 = no fatigue and 10 = as bad as you can imagine. Higher score= worse outcome. | Caregivers did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Fatigue interference (BFI) | The second part of the BFI index The remaining six items assess how much fatigue interfered with: general activity, mood, walking ability, normal work (including work outside the home and daily chores), relations with other people, and enjoyment of life. Responses are on a 0 to 10 scale where 0=does not interfere and 10=completely interferes. High score= worse outcome. | Caregivers did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Summed severity of other symptoms (MDASI) | The expanded M.D. Anderson Symptom Inventory (MDASI) includes 19 symptoms: fatigue, pain, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling, diarrhea, constipation, sore mouth, rash, hair loss, and cough, and the interference of these symptoms with daily life on the scale from 0 = symptom not present to 10 = worst imaginable. Scores are summed, higher score= worse outcome. | Caregivers did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Symptom interference (MDASI) | The MDASI measures how much the symptoms have interfered with six daily activities: general activity, mood, work, relations with others, walking, and enjoyment of life. Interference is rated on a 0-10 numerical rating scale, 0 being "did not interfere" and 10 being "interfered completely." High=worse outcome | Caregivers did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) depression | Self report of depression for patient or caregiver. A score of 50 represents the mean or average of the reference population. A score of 60 means that the participant is one standard deviation above the reference population (standard deviation=10 units). Higher score = worse outcome. | Not all participants responded to question | Mean | Standard Deviation | units on a scale |
|
| PROMIS anxiety | Self reported anxiety measure for patient or caregiver. A score of 50 represents the mean or average of the reference population. A score of 60 means that the participant is one standard deviation above the reference population (standard deviation=10 units). Higher score = worse outcome. | Not all participants responded | Mean | Standard Deviation | units on a scale |
|
| Attentional function index | The Attentional Function Index (AFI) is a self-report questionnaire consisting of 13 items on which respondents rate their effectiveness of their function on common tasks requiring attention and cognitive control from 0 (not at all) to 10 (extremely well). Scores are the average of all 13 items, high score= better outcome. | Caregivers did not report outcome information | Mean | Standard Deviation | units on a scale |
|
| Long Term Quality of Life (LTQL) spirituality | Spiritual/philosophical views of life subscale. Response range 0-44, higher is better. | Caregivers did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Social Support (MSPSS) | Measures perceived social support from different sources (family member or friend) based on a 12 item questionnaire, with a seven point response. 1=very strongly disagree, 7=very strongly agree. Response range 4-28, higher is better. | Caregivers did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| PROMIS physical function | Self report of general physical functioning. A score of 50 represents the mean or average of the reference population. A score of 60 means that the participant is one standard deviation above the reference population (standard deviation=10 units). Higher score = better functioning. | Not all participants responded to question | Mean | Standard Deviation | units on a scale |
|
| PROMIS sleep disturbance | Self report of quality of sleep in the past 7 days. A score of 50 represents the mean or average of the reference population. A score of 60 means that the participant is one standard deviation above the reference population (standard deviation=10 units). Higher score = worse outcome. | Patients did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| PROMIS fatigue | Self report of fatigue in the last seven days. PROMIS fatigue only applies to caregivers as part of PROMIS-29 Profile T-score range 33.-75.8, higher is worse. | Patients did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| PROMIS pain interference | Measure the self-reported consequences of pain on relevant aspects of a person's life. A score of 50 represents the mean or average of the reference population. A score of 60 means that the participant is one standard deviation above the reference population (standard deviation=10 units). Higher score = worse outcome. | Patients did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| PROMIS pain intensity | Self report of pain at its worse in the past seven days. Response range 0-10, 0= no pain, 10= worst imaginable pain. Higher score= worse outcome. | Patients did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Satisfaction with participation in social roles | PROMIS measure of adult satisfaction with participation in social roles, responses on a five point scale with 1=not at all- 5=very much. High score= better outcome. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. | Patients did not report outcome measure | Mean | Standard Deviation | units on a scale |
|
| Caregiver burden | Measure including five subscales: impact of caregiving on schedule, caregiver's esteem, family support, impact on health, and impact on finances. Each question had a five point response scale, 1=strongly disagree- 5=strongly agree. High score= higher burden, worse outcome. | Participant did not respond | Mean | Standard Deviation | units on a scale |
|
| PROMIS- Fatigue Number | Self report fatigue. Higher score= worse outcome. | Only caregivers reported outcome | Mean | Standard Deviation | units on a scale |
|
| OG002 | Control Patients | Control- no intervention |
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 1-4 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 1-4 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 1-4 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 5-12 |
|
|
|
|
| 4 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Meditative Practice | 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 | 5 | 150 | 0 | 150 | 0 | 150 |
| EG002 | Control | Control - no intervention | 0 | 47 | 0 | 47 | 0 | 47 |
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Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Other |
|
| Non Hispanic |
|
| Other |
|
|
| Adult Child |
|
| Parent |
|
| Friend |
|
| Other |
|
| Separately |
|
|
|
| Employed part time |
|
| Retired |
|
| Not employed |
|
| $25,000-$49,000 |
|
| $50,000-$99,000 |
|
| >=$100,000 |
|
| Other |
|
|
|
|
|
|
|
|
|
|
Aim 1: Comparing reflexology vs control for weeks 1-4
| Mixed Models Analysis |
| 0.48 |
| Difference between least squared means |
| -0.2 |
| 2-Sided |
| 95 |
| -0.75 |
| 0.35 |
Difference between reflexology and control for weeks 1-4 |
| Superiority |
| Aim 1: Comparing meditative practice vs control for weeks 1-4 | Mixed Models Analysis | 0.52 | Difference between least squared means | -0.19 | 2-Sided | 95 | -0.75 | 0.38 | Difference between meditative practice and control for weeks 1-4 | Superiority |
Aim 1: Comparing reflexology vs control for weeks 1-4
| Mixed Models Analysis |
| .23 |
| Difference between least squared means |
| -2.53 |
| 2-Sided |
| 95 |
| -6.64 |
| 1.58 |
Comparing reflexology to control for weeks 1-4 |
| Superiority |
| Aim 1: Comparing meditative practice vs control for weeks 1-4 | Mixed Models Analysis | 0.14 | Difference between least squared means | -3.2 | 2-Sided | 95 | -7.41 | 1.01 | Comparing meditative practice to control for weeks 1-4 | Superiority |
Aim 1: Comparing reflexology vs control for weeks 1-4
| Mixed Models Analysis |
| 0.34 |
| Difference between least squared means |
| -0.24 |
| 2-Sided |
| 95 |
| -0.74 |
| 0.25 |
Comparing reflexology to control for weeks 1-4 |
| Superiority |
| Aim 1: Comparing meditative practices vs control for weeks 1-4 | Mixed Models Analysis | 0.34 | Difference between least squared means | -0.25 | 2-Sided | 95 | -0.76 | 0.26 | Comparing meditative practices vs control for weeks 1-4 | Superiority |
Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12 |
| Mixed Models Analysis |
| 0.39 |
| Least Square (LS) Mean |
| 0.49 |
| 2-Sided |
| 95 |
| -0.64 |
| 1.63 |
After the initial 4 weeks of meditative practices, comparing continuing meditative practice to adding reflexology |
| Superiority |
Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12 |
| Mixed Models Analysis |
| 0.66 |
| Least Square (LS) Mean |
| -1.85 |
| 2-Sided |
| 95 |
| -6.59 |
| 10.29 |
After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12 |
| Superiority |
Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12 |
| Mixed Models Analysis |
| 0.95 |
| Least Square (LS) Mean |
| -0.04 |
| 2-Sided |
| 95 |
| -1.15 |
| 1.22 |
After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12 |
| Superiority |
Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12 |
| Mixed Models Analysis |
| 0.67 |
| Least Square (LS) Mean |
| 0.22 |
| 2-Sided |
| 95 |
| -1.23 |
| 0.80 |
After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12 |
| Superiority |
Aim 4: Comparing meditative practices vs control for weeks 5-12
| Mixed Models Analysis |
| 0.29 |
| Least Square (LS) Mean |
| -0.34 |
| 2-Sided |
| 95 |
| -0.98 |
| 0.29 |
Comparing meditative practice vs control for weeks 5-12 |
| Superiority |
Aim 4: Comparing meditative practice vs control for weeks 5-12
| Mixed Models Analysis |
| 0.50 |
| Least Square (LS) Mean |
| -0.2 |
| 2-Sided |
| 95 |
| -0.80 |
| 0.39 |
Comparing meditative practice vs control for weeks 5-12 |
| Superiority |
Aim 4: Comparing meditative practice vs control for weeks 5-12
| Mixed Models Analysis |
| 0.22 |
| Least Square (LS) Mean |
| -0.36 |
| 2-Sided |
| 95 |
| -0.93 |
| 0.21 |
| Superiority |
Aim 4: Comparing meditative practice vs control for weeks 5-12
| Mixed Models Analysis |
| 0.09 |
| Least Square (LS) Mean |
| -4.48 |
| 2-Sided |
| 95 |
| -9.66 |
| 0.70 |
Comparing meditative practice vs control for weeks 5-12 |
| Superiority |