An interventional study of Yoga therapy and questionnaire administration in Fatigue, Nausea and Vomiting and Pain, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by Wake Forest University · Not applicable, Interventional, and Supportive care
This randomized clinical trial studies the preliminary efficacy of a yoga skills training (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue, other treatment-related symptoms, and improve the quality of life (QOL) of patients with colorectal cancer. It is not yet known whether YST is more effective then CE in reducing these outcomes.
OBJECTIVES:
I. To establish the feasibility of implementing a YST among patients undergoing chemotherapy. This includes the feasibility of implementing yoga in a treatment setting, and patient recruitment, adherence, and retention.
II. To obtain preliminary data on the efficacy of a YST for reducing fatigue among patients undergoing chemotherapy.
III. To obtain exploratory data on the impact of a YST on other treatment-related symptoms (e.g., pain, distress, nausea) and QOL.
IV. To obtain exploratory data on the impact of a YST on potential psychological (self-efficacy for coping with cancer, response expectancies for symptoms) and physiological (interleukin [IL]-6 [IL-6], IL-1 Receptor Antagonist [IL-1Ra], tumor necrosis factor- alpha [TNF-a], soluble TNF receptor I [sTNFRI], C-reactive protein [CRP]) mediators that may explain the impact of the YST on fatigue.
OUTLINE: Patients (n=20) are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a compact disc (CD) recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
ARM II: Patients participate in three 15-minute CE sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. Patients also receive CDs with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in Arm I.
The interventions (Week 2, Week 4, Week 6) and assessments (Week 0, Week 4, Week 8) are implemented during visits for chemotherapy (every two weeks).
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 15 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Procedure: Yoga therapy · Other: questionnaire administration · Procedure: quality-of-life assessment · Other: laboratory biomarker analysis · Other: assessment of therapy complications · Procedure: management of therapy complications
Patients participate in three 15-minute CE sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. Patients also receive CDs with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in Arm I.
Other: questionnaire administration · Procedure: quality-of-life assessment · Other: laboratory biomarker analysis · Other: assessment of therapy complications · Procedure: management of therapy complications · Other: educational intervention
receive YST
Ancillary studies
Ancillary studies
Correlative studies
Ancillary studies
Receive YST or CE
Also known as: complications of therapy, management of
Receive CE
Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention)
The proportion of participants who participated in all study sessions and those who completed all assessments will be computed and compared by demographic characteristics and intervention group. The investigators will model the relationship between adherence and baseline scores of the measures, as well as change in scores.
Time frame: Up to 8 weeks
Preliminary efficacy of YST, in terms of reducing fatigue
Measured by the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) subscale. Assessed using analysis of covariance (ANCOVA) models, accounting for possible confounding variables (e.g., medication use) from baseline to post intervention.
Time frame: At week 8
Treatment related symptoms and QOL
The Functional Assessment of Cancer Therapy- Colorectal (FACT-C; 37) will be used to evaluate overall QOL (physical, social, emotional, and functional well-being) and colorectal cancer specific symptoms (e.g., cramps in stomach, control of bowels). Assessed using ANCOVA.
Time frame: At week 8
Mediating variables (self efficacy, response expectancies, inflammatory biomarkers) intervention effect on fatigue, treatment-related symptoms, and QOL
Assessed using a simultaneous model of the mediators and the intervention effect in the ANCOVA model.
Time frame: Up to 8 weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University