Supportive Intervention Programs Study

NCT01590147 | Completed

• 3 other identifiers: IRB00016716NCI-2011-01093CCCWFU 98211
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Nausea and Vomiting; Pain; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage I-IVB Colon Cancer; Stage I-IVB Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 weeks

Secondary Outcomes (3)

• Preliminary efficacy of YST, in terms of reducing fatigue

  At week 8

• Treatment related symptoms and QOL

  At week 8

• Mediating variables (self efficacy, response expectancies, inflammatory biomarkers) intervention effect on fatigue, treatment-related symptoms, and QOL

  Up to 8 weeks

Study Arms (2)

Arm 1 (YST)

EXPERIMENTAL

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

Arm 2 (CE)

ACTIVE COMPARATOR

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

Interventions

Yoga therapy PROCEDURE

receive YST

Arm 1 (YST)

questionnaire administration OTHER

Ancillary studies

Arm 1 (YST); Arm 2 (CE)

quality-of-life assessment PROCEDURE

Ancillary studies

Arm 1 (YST); Arm 2 (CE)

laboratory biomarker analysis OTHER

Correlative studies

Arm 1 (YST); Arm 2 (CE)

assessment of therapy complications OTHER

Ancillary studies

Arm 1 (YST); Arm 2 (CE)

management of therapy complications PROCEDURE

Receive YST or CE

Also known as: complications of therapy, management of

Arm 1 (YST); Arm 2 (CE)

educational intervention OTHER

Receive CE

Arm 2 (CE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed protocol specific informed consent
• Are diagnosed with colorectal cancer
• Recruited within 2 weeks of initiating chemotherapy (including reinitiating chemotherapy after a treatment holiday of greater than or equal to 4 weeks)
• Able to understand written and spoken English

You may not qualify if:

• Under age 18 (children with colorectal cancer)
• Unable to read or understand English
• Vulnerable subjects (except those who are economically or educationally disadvantaged)

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Fatigue; Nausea; Vomiting; Pain; Colonic Neoplasms; Rectal Neoplasms

Interventions

Yoga; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Neurologic Manifestations; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Stephanie J Sohl, PhD

  Wake Forest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 2, 2012
• Study Start: June 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)