Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer

Not Applicable

Active, not recruiting

Conditions: Stage IIIA Cervical Cancer FIGO 2018
Stage IB2 Cervical Cancer FIGO 2018
Stage IIA Cervical Cancer FIGO 2018
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Stage II Cervical Cancer FIGO 2018
Stage IIB Cervical Cancer FIGO 2018
Cervical Adenocarcinoma
Stage IB3 Cervical Cancer FIGO 2018
Stage IIA2 Cervical Cancer FIGO 2018

Interventions: Other: Media Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Other: Survey Administration
Procedure: Yoga

Registration Number: NCT04622670

Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 40

Inclusion Criteria

Score of =< 2 on Eastern Cooperative Oncology Group (ECOG) performance scale
Able to speak English
Federation of Gynecology and Obstetrics (FIGO) stage IB2 through IIIB biopsy-proven CxCa (adenocarcinoma, squamous cell carcinoma, and adenosquamous) with plan to undergo curative outpatient CRT at main campus MD Anderson Cancer Center

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
- It is standard procedure to administer a pregnancy test before the start of CRT. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT) or testing of the blood. Due to radiation and the nature of the disease, a patient becoming pregnant while on study is highly unlikely. In the event a patient were to get pregnant, they would be removed from study because their radiation therapy (RT) might be stopped or fetus would be terminated, which might influence other parameters that are being measured
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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (yoga group)	Survey Administration	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.
Group I (yoga group)	Quality-of-Life Assessment	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.
Group I (yoga group)	Yoga	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.
Group II (wait list control)	Quality-of-Life Assessment	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.
Group I (yoga group)	Questionnaire Administration	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.
Group II (wait list control)	Survey Administration	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.
Group I (yoga group)	Media Intervention	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.
Group II (wait list control)	Media Intervention	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.
Group II (wait list control)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Enrollment to the yoga therapy protocol	Baseline up to 3 months post CRT	90 patients will be screen to obtain at least 40 who are eligible and consent
Adherence to the yoga therapy protocol	Baseline up to 3 months post CRT	At least 10 patients in the YG group must complete at least 50% of the required yoga sessions
Completion in the yoga therapy protocol	Baseline up to 3 months post CRT	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): M D Anderson Cancer Center
🇺🇸
Houston, Texas, United States

Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer

Recruitment & Eligibility

Study & Design

Trial Locations

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