Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility Phase: Eischens Yoga Group |
| ||
| Phase II: Eischens Yoga Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation |
| ||
| Eischens Yoga |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Functional Assessment of Cancer Therapy: Physical Well-Being Score |
Not provided
Inclusion Criteria:
Patients
Caregivers
Exclusion Criteria
Patients
Caregivers
Not provided
Not provided
Not provided
Adults with stage I or II prostate cancer undergoing radiation therapy. Enrolled subjects will not have smoked nor taken any regular yoga classes in the 6 months preceding their participation in the study.
Additionally they will have not undergone a surgical prostatectomy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neha Vapiwala, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Feasibility/Phase II: Radiotherapy and Eischens Yoga | Radiotherapy and Eischens Yoga |
| FG001 | Phase II: Radiotherapy Without Eischens Yoga | Radiotherapy without Eischens Yoga |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Feasibility/Phase II: Radiotherapy and Eischens Yoga | Radiotherapy and Eischens Yoga |
| BG001 | Phase II: Radiotherapy Without Eischens Yoga | Radiotherapy without Eischens Yoga |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Adverse Events | Posted | Number | Adverse Events | 8 weeks |
|
|
8 Weeks
Feasibility Phase and Phase II: Yoga Group have been combined because the feasibility phase's purpose was to identify and recruit patients willing to participate in the Phase II: Yoga Group. Those in the feasibility are seamlessly enrolled in the Phase II: Yoga Group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feasibility/Phase II: Radiotherapy and Eischens Yoga | Radiotherapy and Eischens Yoga |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neha Vapiwala | University of Pennsylvania | (215) 662-2337 | Neha.Vapiwala@pennmedicine.upenn.edu |
Not provided
| 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 | Sep 24, 2014 | May 18, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being
| 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Phase II: Radiotherapy Wihtout Eischens Yoga | Radiotherapy without Eischens Yoga | 0 | 28 | 0 | 28 | 0 | 28 |
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |