Supportive Intervention Programs Study (SIPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephanie Sohl, PhD, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01590147
First received: May 1, 2012
Last updated: July 26, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Supportive Intervention Programs to Lessen Treatment Related Symptoms

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590147

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

No publications provided

Responsible Party: Stephanie Sohl, PhD, Post-Doctoral, Wake Forest University
ClinicalTrials.gov Identifier: NCT01590147     History of Changes
Other Study ID Numbers: CCCWFU 98211, NCI-2011-01093
Study First Received: May 1, 2012
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 20, 2014