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Supportive Intervention Programs Study (SIPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590147
First Posted: May 2, 2012
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie Sohl, PhD, Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Fatigue Nausea and Vomiting Pain Recurrent Colon Cancer Recurrent Rectal Cancer Stage I-IVB Colon Cancer Stage I-IVB Rectal Cancer 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 Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Supportive Intervention Programs to Lessen Treatment Related Symptoms

Further study details as provided by Stephanie Sohl, PhD, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention) [ Time Frame: Up to 8 weeks ]
    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.


Secondary Outcome Measures:
  • Preliminary efficacy of YST, in terms of reducing fatigue [ Time Frame: At week 8 ]
    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.

  • Treatment related symptoms and QOL [ Time Frame: At week 8 ]
    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.

  • Mediating variables (self efficacy, response expectancies, inflammatory biomarkers) intervention effect on fatigue, treatment-related symptoms, and QOL [ Time Frame: Up to 8 weeks ]
    Assessed using a simultaneous model of the mediators and the intervention effect in the ANCOVA model.


Enrollment: 15
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 (YST)
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
receive YST
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
Other: assessment of therapy complications
Ancillary studies
Procedure: management of therapy complications
Receive YST or CE
Other Name: complications of therapy, management of
Active Comparator: Arm 2 (CE)
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
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
Other: assessment of therapy complications
Ancillary studies
Procedure: management of therapy complications
Receive YST or CE
Other Name: complications of therapy, management of
Other: educational intervention
Receive CE

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Under age 18 (children with colorectal cancer)
  • Unable to read or understand English
  • Vulnerable subjects (except those who are economically or educationally disadvantaged)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590147


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Stephanie J Sohl, PhD Wake Forest
  More Information

Responsible Party: Stephanie Sohl, PhD, Post-Doctoral, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01590147     History of Changes
Other Study ID Numbers: CCCWFU 98211
NCI-2011-01093 ( Registry Identifier: NCI )
First Submitted: May 1, 2012
First Posted: May 2, 2012
Last Update Posted: March 28, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rectal Neoplasms
Colonic Neoplasms
Fatigue
Vomiting
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Signs and Symptoms
Signs and Symptoms, Digestive