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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02021 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0919 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well yoga therapy works during chemotherapy and radiation treatment in improving physical and emotional well-being in patients with stage IB2-IIIB cervical cancer. Yoga therapy may help to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions.
PRIMARY OBJECTIVE:
I. Establish feasibility of delivering a yoga therapy program during chemotherapy and radiation therapy (CRT) for loco-regionally advanced cervical cancer undergoing chemo-radiotherapy.
SECONDARY OBJECTIVES:
I. Measure the effects and variance of yoga on fatigue, depression, anxiety, pelvic pain and over-all quality of life (QOL) in cervical cancer (CxCa) patients undergoing primary treatment with CRT.
II. Examine changes in other psychosocial outcomes including ability to find meaning in the illness, spirituality and sexuality.
EXPLORATORY OBJECTIVE:
I. Evaluate whether markers of stress response (plasma levels of other pro-inflammatory cytokines, including interleukin-6 [IL-6], and IL-8, IL-10, VEGF, and CRP) change in response to yoga therapy and their association with fatigue, depression, anxiety, pelvic pain, meaning in the illness, experience, spirituality, and QOL in CxCa patients undergoing primary CRT.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (YOGA GROUP): Patients attend at least 2 yoga classes per week over 5-6 weeks lasting approximately 60 minutes each for up to 15 classes during the CRT. Patients also complete surveys pre-treatment, once a week, and post-treatment and receive a yoga manual and DVD during and after CRT.
GROUP II (WAIT LIST CONTROL): Patients refrain from participating in any new stress management activities and receive a DVD. Patients are also offered 4 group yoga classes after 3 months of CRT. Patients also complete surveys as in Group I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (yoga group) | Experimental | Patients attend at least 2 yoga classes per week over 5-6 weeks lasting approximately 60 minutes each for up to 15 classes during the CRT. Patients also complete surveys pre-treatment, once a week, and post-treatment over and receive a yoga manual and DVD during and after CRT. |
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| Group II (wait list control) | Active Comparator | Patients refrain from participating in any new stress management activities and receive a DVD. Patients are also offered 4 group yoga classes after 3 months of CRT. Patients also complete surveys as in Group I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Media Intervention | Other | Receive DVD |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment to the yoga therapy protocol | 90 patients will be screen to obtain at least 40 who are eligible and consent | Baseline up to 3 months post CRT |
| Adherence to the yoga therapy protocol | At least 10 patients in the YG group must complete at least 50% of the required yoga sessions | Baseline up to 3 months post CRT |
| Completion in the yoga therapy protocol | At least 25 of the 40 patients must complete any of the follow up measure between T3 and T5 in order to declare this study feasible | Baseline up to 3 months post CRT |
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Inclusion Criteria:
Exclusion Criteria:
Medically documented restrictions at enrollment that could interfere with participation in the yoga interventions (i.e. uncontrolled vaginal bleeding)
Medical illness that would prevent administration of full-dose chemotherapy
Concurrent diagnosis of a second cancer
Prior hysterectomy
Neuroendocrine histology
Patients who are pregnant
Patients with major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)
Patients with extreme mobility issues, and
Patients who have had a regular yoga practice (at least one time a month) in past 6 months prior to study enrollment or who are currently engaged in a regular mind-body practice
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| Name | Affiliation | Role |
|---|---|---|
| Lois M Ramondetta, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2023 | Oct 24, 2024 |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Yoga | Procedure | Attend yoga class |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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