Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone, Pain
Conditions
Brief summary
This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis). Palliative radiation therapy using external beam radiation therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction. SECONDARY OBJECTIVES: I. To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief compared to 8 Gy x 1 fraction. II. To determine whether 8 Gy x 2 fractions is associated with improved quality of life compared to 8 Gy x 1 fraction. III. To determine whether use of a bone strengthening agent is associated with improved pain relief, narcotic relief and re-treatment rates. IV. To determine if 8 Gy x 2 fractions is associated with increased toxicity. V. To correlate patient satisfaction, perceived stress, and social support with treatment outcomes. TERTIARY OBJECTIVES: OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo 1 fraction of external beam radiation therapy (EBRT) over 30 minutes. ARM II: Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. After completion of study treatment, patients are followed up at 30 days and at 3 months.
Interventions
RADIATIONExternal Beam Radiation Therapy
Undergo EBRT
RADIATIONPalliative Radiation Therapy
Undergo EBRT
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of cancer, not including multiple myeloma * Radiographic evidence of bone metastases within 8 weeks of study; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites * Eligible treatment sites are: * Weight bearing sites * Pelvis (excluding pubis) * Femur * Sacrum and/or sacroiliac joints * Tibia * Non-weight bearing sites * Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies * Lumbosacral spine * Up to 3 consecutive ribs * Humerus * Fibula * Radius ± ulna * Clavicle * Sternum * Scapula * Pubis If multiple sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur or tibia * Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain score \< 5 with \>= 60 mg of morphine (or equivalent) per day * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document * Negative pregnancy test at study registration * Changes in systemic chemotherapy, hormonal therapy or the use of bisphosphonates for 4 weeks before and after the delivery of radiotherapy are allowed, but recording and accounting for this in the statistical analysis is required * Life expectancy of at least 12 weeks as deemed by the treating oncologist * Patients will be eligible for treatment of multiple osseous sites only if those sites can be included in no more than three treatment sites; for patients with painful metastases that are contiguous but do not fit into the definition of a site listed above, those patients will still be eligible but will be considered to have two treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be eligible but would be considered as two treatment sites since more than five consecutive vertebral bodies would be treated; these lesions could be treated with one field, even though the treatment is coded as two sites
Exclusion criteria
* Previous radiotherapy or palliative surgery to the painful site * Metastases to the skull, hands, feet are not eligible treatment sites * Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | Up to 6 months post-treatment | The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | At 3 months and 6 months post-treatment | Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. The rating pain scale is from 0-10, with 0 being no pain, 8-10 worst possible pain. |
| Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | At 3 months and 6 months post-treatment | Analyses will be performed that examine whether there are associations between quality of life and treatment outcome (re-treatment rates or amount of pain relief). Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Either multiple logistic regression (for binary outcomes) models or analysis of covariance (ANCOVA) models for continuous outcomes will be used. The QLQ-C15-PAL has high sensitivity and specificity for identifying clinically important symptoms and functional health impairments. Scores range from 0 to 100 with higher values indicating a better quality of life in the Physical and Emotional Functioning and Quality of Life categories. Higher scores in Symptoms Scales categories indicates a worse quality of life. Most questions are rated on a 4-point Likert scale (1 = not at all to 4 = very much), but the global quality of life item uses a 7-point scale (1 = very poor to 7 = excellent) |
| Incidence of Adverse Events - Grade 3 or Higher | Up to 6 months post-treatment | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Groups will be compared to determine whether there are any differences in the number or severity of toxicities. When comparing severity of toxicities between groups, chi-square tests will be examined. The Cochran-Armitage trend test can be used to determine if there is evidence a trend in severity of toxicities when comparing groups. Because of the patient population as well as the treatment, emphasis will be placed on gastrointestinal (GI disturbance, esophagitis, diarrhea, nausea, and vomiting), hematological (low blood counts or bleeding), spinal (bone fracture, compression fracture, insufficiency, or myelitis), and pulmonary toxicities (pneumonitis) and recorded by clinical research coordinators. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to the event. |
| Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | At 3 months and 6 months post-treatment | Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. |
| Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | At 3 months and 6 months post-treatment | The Perceived Stress Scale (PSS) is a stress assessment instrumentto help understand how different situations affect feelings and perceived stress. Scoring scale is 1 (never) to 4 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced. The Perceived Stress Scale (PSS-10) is scored by summing the responses to all 10 items, with a total score ranging from 0 to 40. To get the score, you first need to reverse the scoring for the positively worded items (items 4, 5, 7, and 8). A total score of 0-13 suggests low stress, 14-26 indicates moderate stress, and 27-40 represents high stress. Perceived helplessness (items 1, 2, 3, 6, 9, 10) - measuring an individual's feelings of a lack of control over their circumstances or their own emotions or reactions. Lack of self-efficacy (items 4, 5, 7, 8) - measuring an individual's perceived inability to handle problems. |
| Participants With Social Support Assessed Via Self-Reported Surveys | At 3 months and 6 months post-treatment | Association between social support and treatment outcomes will be assessed. Social support will be measured by answering a series of questions with a scoring scale range of 1 (definitely false for you) to 4 (definitely true for you). The total score is the sum of all items, ranging from 0 to 36. Sum the scores for the four items in each subscale (Appraisal, Belonging, and Tangible) to get a score ranging from 0 to 12 for each subscale. The higher the total score the more support the participants receive from their support network. |
| Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | At 3 months and 6 months post-treatment | Analyses will be performed that examine whether there are associations between patient satisfaction and treatment outcome (re-treatment rates or amount of pain relief). Satisfaction will be measured by answering a series of questions with a scoring scale range of 1 (strongly agree) to 5 (strongly disagree). The scoring range for the Patient Satisfaction with Cancer Care (PSCC)-18 is 18 (best score) to 90 (worse score). A lower total score indicates higher satisfaction with cancer care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Control) 8 Gy x 1 Patients undergo 1 fraction of EBRT over 30 minutes. | 51 |
| Arm B (Treatment) 8 Gy x 2 Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. | 51 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 18 | 15 |
| Overall Study | Entered hospice care | 5 | 2 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Missing reason for discontinuation | 6 | 5 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Refused to follow up | 1 | 1 |
Baseline characteristics
| Characteristic | Arm A (Control) 8 Gy x 1 | Arm B (Treatment) 8 Gy x 2 | Total |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 14 | 64.8 years STANDARD_DEVIATION 10.8 | 63.35 years STANDARD_DEVIATION 12.4 |
| Any prior cancer therapy | 32 Participants | 24 Participants | 56 Participants |
| Currently using bisphosphonates/ Denosumab? | 10 Participants | 4 Participants | 14 Participants |
| ECOG Performance Status 0-1 | 31 Participants | 34 Participants | 65 Participants |
| ECOG Performance Status 2-3 | 17 Participants | 17 Participants | 34 Participants |
| History of weight loss? | 18 Participants | 16 Participants | 34 Participants |
| Medical History AIDS | 0 Participants | 0 Participants | 0 Participants |
| Medical History Brain | 9 Participants | 8 Participants | 17 Participants |
| Medical History Cerebrovascular disease | 6 Participants | 5 Participants | 11 Participants |
| Medical History Chronic pulmonary disease | 3 Participants | 8 Participants | 11 Participants |
| Medical History Congestive heart failure | 2 Participants | 2 Participants | 4 Participants |
| Medical History Connective tissue disease | 0 Participants | 2 Participants | 2 Participants |
| Medical History Dementia | 0 Participants | 1 Participants | 1 Participants |
| Medical History Diabetes | 5 Participants | 12 Participants | 17 Participants |
| Medical History Hemiplegia | 1 Participants | 1 Participants | 2 Participants |
| Medical History Liver | 13 Participants | 12 Participants | 25 Participants |
| Medical History Liver disease | 0 Participants | 1 Participants | 1 Participants |
| Medical History Myocardial infarction | 3 Participants | 1 Participants | 4 Participants |
| Medical History Other cancer | 14 Participants | 15 Participants | 29 Participants |
| Medical History Other sites of metastases | 37 Participants | 35 Participants | 72 Participants |
| Medical History Peptic ulcer disease | 2 Participants | 2 Participants | 4 Participants |
| Medical History Peripheral vascular disease | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 50 Participants | 50 Participants | 100 Participants |
| Race/Ethnicity, Customized Race Asian Indian/Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Unable to obtain | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 40 Participants | 42 Participants | 82 Participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 29 Participants | 30 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 19 / 51 | 17 / 51 |
| other Total, other adverse events | 32 / 51 | 32 / 51 |
| serious Total, serious adverse events | 19 / 51 | 37 / 51 |
Outcome results
Primary
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)
The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.
Time frame: Up to 6 months post-treatment
Population: Analysis was performed with death as a competing risk.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | Retreatment | 3 Participants |
| Arm A (Control) 8 Gy x 1 | Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | Death | 19 Participants |
| Arm B (Treatment) 8 Gy x 2 | Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | Retreatment | 3 Participants |
| Arm B (Treatment) 8 Gy x 2 | Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | Death | 17 Participants |
p-value: 0.8325t-test, 2 sided
Secondary
Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use
Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. The rating pain scale is from 0-10, with 0 being no pain, 8-10 worst possible pain.
Time frame: At 3 months and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | Narcotic use in daily morphine equivalents - 6 months | 5 MME per day | Standard Deviation 7.3 |
| Arm A (Control) 8 Gy x 1 | Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | Narcotic use in daily morphine equivalents - 3 months | 6 MME per day | Standard Deviation 18.2 |
| Arm B (Treatment) 8 Gy x 2 | Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | Narcotic use in daily morphine equivalents - 3 months | 9 MME per day | Standard Deviation 29 |
| Arm B (Treatment) 8 Gy x 2 | Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | Narcotic use in daily morphine equivalents - 6 months | 6 MME per day | Standard Deviation 5 |
Comparison: Narcotic use at 3 monthsp-value: 0.3058t-test, 2 sided
Comparison: Narcotic use at 6 monthsp-value: 0.5337t-test, 2 sided
Secondary
Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale
Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion.
Time frame: At 3 months and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | Continuous scale - 3 months | 4.4 score on a scale | Standard Deviation 3.7 |
| Arm A (Control) 8 Gy x 1 | Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | Continuous scale - 6 months | 4.2 score on a scale | Standard Deviation 3.6 |
| Arm B (Treatment) 8 Gy x 2 | Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | Continuous scale - 3 months | 3.8 score on a scale | Standard Deviation 3.1 |
| Arm B (Treatment) 8 Gy x 2 | Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | Continuous scale - 6 months | 4.4 score on a scale | Standard Deviation 3 |
Comparison: Continuous pain scale p-value at 3 monthsp-value: 0.5593t-test, 2 sided
Comparison: Continuous pain scale p-value at 6 monthsp-value: 0.8133t-test, 2 sided
Secondary
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Analyses will be performed that examine whether there are associations between quality of life and treatment outcome (re-treatment rates or amount of pain relief). Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Either multiple logistic regression (for binary outcomes) models or analysis of covariance (ANCOVA) models for continuous outcomes will be used. The QLQ-C15-PAL has high sensitivity and specificity for identifying clinically important symptoms and functional health impairments. Scores range from 0 to 100 with higher values indicating a better quality of life in the Physical and Emotional Functioning and Quality of Life categories. Higher scores in Symptoms Scales categories indicates a worse quality of life. Most questions are rated on a 4-point Likert scale (1 = not at all to 4 = very much), but the global quality of life item uses a 7-point scale (1 = very poor to 7 = excellent)
Time frame: At 3 months and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Physical Functioning - 6 months | 87.0 score on a scale | Standard Deviation 14.9 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Physical Functioning - 3 months | 65.7 score on a scale | Standard Deviation 28.5 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Emotional Functioning - 3 months | 74.0 score on a scale | Standard Deviation 30.5 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Emotional Functioning - 6 months | 84.7 score on a scale | Standard Deviation 20.7 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Dyspnea | 26.4 score on a scale | Standard Deviation 29.5 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Pain | 52.7 score on a scale | Standard Deviation 30.3 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Insomnia | 33.3 score on a scale | Standard Deviation 31.1 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Fatigue | 50.0 score on a scale | Standard Deviation 30 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Appetite loss | 37.5 score on a scale | Standard Deviation 37.2 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Nausea/vomiting | 22.2 score on a scale | Standard Deviation 23.4 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Constipation | 29.3 score on a scale | Standard Deviation 30.9 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Quality of Life - 3 months | 62.7 score on a scale | Standard Deviation 27.8 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Dyspnea | 19.4 score on a scale | Standard Deviation 26.4 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Pain | 37.5 score on a scale | Standard Deviation 28.5 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Insomnia | 27.8 score on a scale | Standard Deviation 34.3 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Fatigue | 31.9 score on a scale | Standard Deviation 26.1 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Appetite loss | 25.0 score on a scale | Standard Deviation 35.2 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) Nausea/vomiting | 22.2 score on a scale | Standard Deviation 21.7 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Constipation | 16.7 score on a scale | Standard Deviation 22.5 |
| Arm A (Control) 8 Gy x 1 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Quality of Life - 6 months | 79.2 score on a scale | Standard Deviation 12.6 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) Nausea/vomiting | 33.3 score on a scale | Standard Deviation 34.3 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Physical Functioning - 6 months | 64.2 score on a scale | Standard Deviation 31.3 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Constipation | 31.9 score on a scale | Standard Deviation 38.2 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Physical Functioning - 3 months | 72.2 score on a scale | Standard Deviation 24.9 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Fatigue | 48.1 score on a scale | Standard Deviation 31.3 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Emotional Functioning - 3 months | 75.4 score on a scale | Standard Deviation 26.5 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Quality of Life - 3 months | 60.1 score on a scale | Standard Deviation 24.5 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Emotional Functioning - 6 months | 79.6 score on a scale | Standard Deviation 27.1 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Quality of Life - 6 months | 63.9 score on a scale | Standard Deviation 30.9 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Dyspnea | 22.7 score on a scale | Standard Deviation 34.7 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Dyspnea | 31.5 score on a scale | Standard Deviation 38.7 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Pain | 52.2 score on a scale | Standard Deviation 31.5 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Appetite loss | 27.8 score on a scale | Standard Deviation 38.3 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Insomnia | 27.3 score on a scale | Standard Deviation 28.4 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Pain | 55.6 score on a scale | Standard Deviation 37 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Fatigue | 47.8 score on a scale | Standard Deviation 24.8 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Constipation | 33.3 score on a scale | Standard Deviation 28 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Appetite loss | 25.8 score on a scale | Standard Deviation 25.1 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (6 months) - Insomnia | 40.7 score on a scale | Standard Deviation 38.9 |
| Arm B (Treatment) 8 Gy x 2 | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Symptom Scales (3 months) - Nausea/vomiting | 16.7 score on a scale | Standard Deviation 19.9 |
Comparison: Physical Functioning p-value at 3 monthsp-value: 0.4182t-test, 2 sided
Comparison: Emotional functioning p-value at 3 monthsp-value: 0.87t-test, 2 sided
Comparison: Symptom Scales - Dyspnea at 3 monthsp-value: 0.7008t-test, 2 sided
Comparison: Symptom Scale Pain at 3 monthsp-value: 0.9562t-test, 2 sided
Comparison: Symptom Scale Insomnia at 3 monthsp-value: 0.4951t-test, 2 sided
Comparison: Symptom Scale Fatigue at 3 monthsp-value: 0.7868t-test, 2 sided
Comparison: Symptom Scale Appetite loss at 3 monthsp-value: 0.22t-test, 2 sided
Comparison: Symptom Scale Nausea/vomiting at 3 monthsp-value: 0.7998t-test, 2 sided
Comparison: Symptom Scale Constipation at 3 monthsp-value: 0.7998t-test, 2 sided
Comparison: Symptom Scale Quality of Life at 3 monthsp-value: 0.7409t-test, 2 sided
Comparison: Physical Functioning at 6 monthsp-value: 0.0128t-test, 2 sided
Comparison: Emotional Functioning at 6 monthsp-value: 0.5861t-test, 2 sided
Comparison: Symptom Scales - Dyspnea at 6 monthsp-value: 0.3561t-test, 2 sided
Comparison: Symptom Scales - Pain at 6 monthsp-value: 0.1647t-test, 2 sided
Comparison: Symptom Scales - Insomnia at 6 monthsp-value: 0.3571t-test, 2 sided
Comparison: Symptom Scales - Fatigue at 6 monthsp-value: 0.1494t-test, 2 sided
Comparison: Symptom Scales - Appetite loss at 6 monthsp-value: 0.8424t-test, 2 sided
Comparison: Symptom Scales - Nausea/vomiting at 6 monthsp-value: 0.3287t-test, 2 sided
Comparison: Symptom Scales - Constipation at 6 monthsp-value: 0.0961t-test, 2 sided
Secondary
Incidence of Adverse Events - Grade 3 or Higher
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Groups will be compared to determine whether there are any differences in the number or severity of toxicities. When comparing severity of toxicities between groups, chi-square tests will be examined. The Cochran-Armitage trend test can be used to determine if there is evidence a trend in severity of toxicities when comparing groups. Because of the patient population as well as the treatment, emphasis will be placed on gastrointestinal (GI disturbance, esophagitis, diarrhea, nausea, and vomiting), hematological (low blood counts or bleeding), spinal (bone fracture, compression fracture, insufficiency, or myelitis), and pulmonary toxicities (pneumonitis) and recorded by clinical research coordinators. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to the event.
Time frame: Up to 6 months post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Nausea - Grade 3 | 1 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Nausea - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Nausea - Grade 5 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Anemia - Grade 3 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Anemia - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Anemia - Grade 5 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Diarrhea - Grade 3 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Diarrhea - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Diarrhea - Grade 5 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Fatigue - Grade 3 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Fatigue - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Fatigue - Grade 5 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Pain - Grade 3 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Pain - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Pain - Grade 5 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Dehydration - Grade 3 | 1 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Dehydration - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Dehydration - Grade 5 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Dyspnea - Grade 3 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Dyspnea - Grade 4 | 0 participants |
| Arm A (Control) 8 Gy x 1 | Incidence of Adverse Events - Grade 3 or Higher | Dyspnea - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Fatigue - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Nausea - Grade 3 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Dyspnea - Grade 3 | 1 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Nausea - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Fatigue - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Nausea - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Dehydration - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Anemia - Grade 3 | 1 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Pain - Grade 3 | 1 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Anemia - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Dyspnea - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Anemia - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Pain - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Diarrhea - Grade 3 | 1 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Dehydration - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Diarrhea - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Pain - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Diarrhea - Grade 5 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Dyspnea - Grade 4 | 0 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Fatigue - Grade 3 | 1 participants |
| Arm B (Treatment) 8 Gy x 2 | Incidence of Adverse Events - Grade 3 or Higher | Dehydration - Grade 3 | 0 participants |
Secondary
Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)
Analyses will be performed that examine whether there are associations between patient satisfaction and treatment outcome (re-treatment rates or amount of pain relief). Satisfaction will be measured by answering a series of questions with a scoring scale range of 1 (strongly agree) to 5 (strongly disagree). The scoring range for the Patient Satisfaction with Cancer Care (PSCC)-18 is 18 (best score) to 90 (worse score). A lower total score indicates higher satisfaction with cancer care.
Time frame: At 3 months and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | 3 months | 25.8 score on a scale | Standard Deviation 8.9 |
| Arm A (Control) 8 Gy x 1 | Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | 6 months | 25.4 score on a scale | Standard Deviation 10 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | 3 months | 26.3 score on a scale | Standard Deviation 8.2 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | 6 months | 26.0 score on a scale | Standard Deviation 10.1 |
Comparison: At 3 months, total score for PSCC-18p-value: 0.8444t-test, 2 sided
Comparison: At 6 months, total score for PSCC-18p-value: 0.8946t-test, 2 sided
Secondary
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS) is a stress assessment instrumentto help understand how different situations affect feelings and perceived stress. Scoring scale is 1 (never) to 4 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced. The Perceived Stress Scale (PSS-10) is scored by summing the responses to all 10 items, with a total score ranging from 0 to 40. To get the score, you first need to reverse the scoring for the positively worded items (items 4, 5, 7, and 8). A total score of 0-13 suggests low stress, 14-26 indicates moderate stress, and 27-40 represents high stress. Perceived helplessness (items 1, 2, 3, 6, 9, 10) - measuring an individual's feelings of a lack of control over their circumstances or their own emotions or reactions. Lack of self-efficacy (items 4, 5, 7, 8) - measuring an individual's perceived inability to handle problems.
Time frame: At 3 months and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived helplessness total (3 months) | 8.7 score on a scale | Standard Deviation 5.6 |
| Arm A (Control) 8 Gy x 1 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived self-efficacy total (3 months) | 5.6 score on a scale | Standard Deviation 3.6 |
| Arm A (Control) 8 Gy x 1 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Total PSS-10 score (3 months) | 14.2 score on a scale | Standard Deviation 8.1 |
| Arm A (Control) 8 Gy x 1 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived helplessness total (6 months) | 5.9 score on a scale | Standard Deviation 4.4 |
| Arm A (Control) 8 Gy x 1 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived self-efficacy total (6 months) | 4.7 score on a scale | Standard Deviation 3.4 |
| Arm A (Control) 8 Gy x 1 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Total PSS-10 score (6 months) | 10.6 score on a scale | Standard Deviation 7.2 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived self-efficacy total (6 months) | 5.6 score on a scale | Standard Deviation 4.4 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived helplessness total (3 months) | 8.0 score on a scale | Standard Deviation 6.1 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived helplessness total (6 months) | 8.6 score on a scale | Standard Deviation 6.9 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Perceived self-efficacy total (3 months) | 4.7 score on a scale | Standard Deviation 3.7 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Total PSS-10 score (6 months) | 14.5 score on a scale | Standard Deviation 10.7 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | Total PSS-10 score (3 months) | 13.0 score on a scale | Standard Deviation 8.6 |
Comparison: Perceived helplessness total at 3 monthsp-value: 0.67t-test, 2 sided
Comparison: Perceived self-efficacy total at 3 monthsp-value: 0.435t-test, 2 sided
Comparison: Total PSS-10 score at 3 monthsp-value: 0.6131t-test, 2 sided
Comparison: Perceived helplessness total at 6 monthsp-value: 0.2518t-test, 2 sided
Comparison: Perceived self-efficacy totalp-value: 0.5529t-test, 2 sided
Comparison: Total PSS-10 score at 6 monthsp-value: 0.2833t-test, 2 sided
Secondary
Participants With Social Support Assessed Via Self-Reported Surveys
Association between social support and treatment outcomes will be assessed. Social support will be measured by answering a series of questions with a scoring scale range of 1 (definitely false for you) to 4 (definitely true for you). The total score is the sum of all items, ranging from 0 to 36. Sum the scores for the four items in each subscale (Appraisal, Belonging, and Tangible) to get a score ranging from 0 to 12 for each subscale. The higher the total score the more support the participants receive from their support network.
Time frame: At 3 months and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Appraisal Support subscale total (3 months) | 6.5 score on a scale | Standard Deviation 1.5 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Belonging Support subscale total (3 months) | 5.8 score on a scale | Standard Deviation 1.4 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Tangible Support subscale total (3 months) | 8.1 score on a scale | Standard Deviation 1.7 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Total ISEL score (3 months) | 20.2 score on a scale | Standard Deviation 3.3 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Appraisal Support subscale total (6 months) | 6.3 score on a scale | Standard Deviation 1.3 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Belonging Support subscale total (6 months) | 6.2 score on a scale | Standard Deviation 2 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Tangible Support subscale total (6 months) | 8.5 score on a scale | Standard Deviation 1.4 |
| Arm A (Control) 8 Gy x 1 | Participants With Social Support Assessed Via Self-Reported Surveys | Total ISEL score (6 months) | 20.9 score on a scale | Standard Deviation 2.2 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Total ISEL score (6 months) | 21.4 score on a scale | Standard Deviation 1.4 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Appraisal Support subscale total (3 months) | 6.0 score on a scale | Standard Deviation 1.7 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Appraisal Support subscale total (6 months) | 6.1 score on a scale | Standard Deviation 0.8 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Belonging Support subscale total (3 months) | 6.0 score on a scale | Standard Deviation 1.9 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Tangible Support subscale total (6 months) | 8.7 score on a scale | Standard Deviation 1 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Tangible Support subscale total (3 months) | 8.8 score on a scale | Standard Deviation 1.7 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Belonging Support subscale total (6 months) | 6.6 score on a scale | Standard Deviation 1.1 |
| Arm B (Treatment) 8 Gy x 2 | Participants With Social Support Assessed Via Self-Reported Surveys | Total ISEL score (3 months) | 20.8 score on a scale | Standard Deviation 4.3 |
Comparison: Appraisal Support subscale total at 3 monthsp-value: 0.3784t-test, 2 sided
Comparison: Belonging Support subscale total at 3 monthsp-value: 0.664t-test, 2 sided
Comparison: Tangible Support subscale total at 3 monthsp-value: 0.1745t-test, 2 sided
Comparison: Total ISEL score at 3 monthsp-value: 0.5792t-test, 2 sided
Comparison: Appraisal Support subscale total at 6 monthsp-value: 0.6814t-test, 2 sided
Comparison: Belonging Support subscale total at 6 monthsp-value: 0.5219t-test, 2 sided
Comparison: Tangible Support subscale totalp-value: 0.5516t-test, 2 sided
Comparison: Total ISEL score at 6 monthsp-value: 0.4329t-test, 2 sided