Prostate Cancer
Conditions
Brief summary
This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.
Detailed description
The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.
Interventions
RADIATIONRadiotherapy
OTHEREischens Yoga
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients * Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted. * Patients of age \>18 years, and all races will be included in the study. * Patients must have an ECOG Performance Score ≤ 1 * All patients must sign an informed consent form Caregivers * Subject is age \>18 years * Subject is English-speaking * Subject must sign an informed consent form
Exclusion criteria
Patients * Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score. * Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included) * Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months). * Patients who are undergoing chemotherapy for any reason * Patients with evidence of metastatic disease Caregivers * Subjects that are unwilling or unable to provide informed consent * Subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions * Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included) * Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy: Physical Well-Being Score | 8 weeks | 7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being |
| Functional Assessment of Cancer Therapy: Social Well-Being Score | 8 weeks | 7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being |
| Functional Assessment of Cancer Therapy: Emotional Well-Being Score | 8 weeks | 6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being |
| Brief Fatigue Inventory Score | 8 weeks | A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue |
| International Index of Erectile Function Score | 8 weeks | 5 item and 5 point Likert-scale The scores range from 0 to 25, with scores \>21 indicating normal erectile function and scores \<12 indicating moderate to severe ED |
| International Prostate Symptom Score | 8 weeks | 8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms |
| Functional Assessment of Cancer Therapy: Functional Well-Being | 8 weeks | 7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being |
Countries
United States
Participant flow
Pre-assignment details
Feasibility Phase and Phase II: Radiotherapy and Eischens Yoga have been combined because the feasibility phase's purpose was to identify and recruit patients willing to participate in the Phase II: Radiotherapy and Eischens Yoga. Those in the feasibility are seamlessly enrolled in the Phase II: Radiotherapy and Eischens Yoga.
Participants by arm
| Arm | Count |
|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga Radiotherapy and Eischens Yoga | 22 |
| Phase II: Radiotherapy Without Eischens Yoga Radiotherapy without Eischens Yoga | 28 |
| Total | 50 |
Baseline characteristics
| Characteristic | Feasibility/Phase II: Radiotherapy and Eischens Yoga | Phase II: Radiotherapy Without Eischens Yoga | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 23 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 71.1 years STANDARD_DEVIATION 6.7 | 72.8 years STANDARD_DEVIATION 7 | 72.08 years STANDARD_DEVIATION 6.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 28 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 19 Participants | 24 Participants | 43 Participants |
| Region of Enrollment United States | 22 participants | 28 participants | 50 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 28 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 28 |
| other Total, other adverse events | 0 / 22 | 0 / 28 |
| serious Total, serious adverse events | 0 / 22 | 0 / 28 |
Outcome results
Primary
Adverse Events
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | Adverse Events | 0 Adverse Events |
| Phase II: Radiotherapy Without Eischens Yoga | Adverse Events | 0 Adverse Events |
Secondary
Brief Fatigue Inventory Score
A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | Brief Fatigue Inventory Score | 12.2 score on a scale | Standard Deviation 16.3 |
| Phase II: Radiotherapy Without Eischens Yoga | Brief Fatigue Inventory Score | 27.4 score on a scale | Standard Deviation 18.3 |
Secondary
Functional Assessment of Cancer Therapy: Emotional Well-Being Score
6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | Functional Assessment of Cancer Therapy: Emotional Well-Being Score | 20.1 score on a scale | Standard Deviation 3.4 |
| Phase II: Radiotherapy Without Eischens Yoga | Functional Assessment of Cancer Therapy: Emotional Well-Being Score | 21.0 score on a scale | Standard Deviation 2.2 |
Secondary
Functional Assessment of Cancer Therapy: Functional Well-Being
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | Functional Assessment of Cancer Therapy: Functional Well-Being | 22.5 score on a scale | Standard Deviation 4.8 |
| Phase II: Radiotherapy Without Eischens Yoga | Functional Assessment of Cancer Therapy: Functional Well-Being | 21.4 score on a scale | Standard Deviation 4 |
Secondary
Functional Assessment of Cancer Therapy: Physical Well-Being Score
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | Functional Assessment of Cancer Therapy: Physical Well-Being Score | 24.9 score on a scale | Standard Deviation 2.3 |
| Phase II: Radiotherapy Without Eischens Yoga | Functional Assessment of Cancer Therapy: Physical Well-Being Score | 24.3 score on a scale | Standard Deviation 3 |
Secondary
Functional Assessment of Cancer Therapy: Social Well-Being Score
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | Functional Assessment of Cancer Therapy: Social Well-Being Score | 23.5 score on a scale | Standard Deviation 2.1 |
| Phase II: Radiotherapy Without Eischens Yoga | Functional Assessment of Cancer Therapy: Social Well-Being Score | 21.4 score on a scale | Standard Deviation 3.6 |
Secondary
International Index of Erectile Function Score
5 item and 5 point Likert-scale The scores range from 0 to 25, with scores \>21 indicating normal erectile function and scores \<12 indicating moderate to severe ED
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | International Index of Erectile Function Score | 22.5 score on a scale | Standard Deviation 4.8 |
| Phase II: Radiotherapy Without Eischens Yoga | International Index of Erectile Function Score | 21.4 score on a scale | Standard Deviation 4 |
Secondary
International Prostate Symptom Score
8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility/Phase II: Radiotherapy and Eischens Yoga | International Prostate Symptom Score | 10.8 score on a scale | Standard Deviation 8.1 |
| Phase II: Radiotherapy Without Eischens Yoga | International Prostate Symptom Score | 15 score on a scale | Standard Deviation 6.4 |