FatigueSIPSNCT01590147
Supportive Intervention Programs Study
A study testing Yoga therapy, questionnaire administration and quality-of-life assessment in people with Fatigue and Nausea and Vomiting, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Nausea and Vomiting, Pain
- What is being tested?
- Yoga therapy, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under age 18 (children with colorectal cancer)
- Unable to read or understand English
- Vulnerable subjects (except those who are economically or educationally disadvantaged)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Supportive Intervention Programs to Lessen Treatment Related Symptoms
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.
Read the detailed description
OBJECTIVES:
- 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).
- Conditions
- Fatigue, Nausea and Vomiting, Pain, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage I-IVB Colon Cancer
- Being tested
- Yoga therapy, questionnaire administration, quality-of-life assessment, laboratory biomarker analysis, assessment of therapy complications
- Medical subject headings
- Fatigue, Nausea, Vomiting, Pain, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga therapyProcedure or surgery
receive YST
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
assessment of therapy complicationsOther
Ancillary studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Receive YST or CE
educational interventionOther
Receive CE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie J Sohl, PhD, Principal investigator, Wake Forest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590147
- Sponsor's protocol ID
- IRB00016716
- Other IDs
- NCI-2011-01093, CCCWFU 98211
- Acronym
- SIPS
- Status last verified
- Aug 2018
- First submitted
- 1 May 2012
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Intervention Programs to Lessen Treatment Related Symptoms
- ClinicalTrials.gov ID
- NCT01590147
- Acronym / sponsor ID
- SIPS / IRB00016716
- Conditions
- Fatigue, Nausea and Vomiting, Pain, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage I-IVB Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (YST) | Experimental | Procedure: Yoga therapy, Other: questionnaire administration, Procedure: quality-of-life assessment, Other: laboratory biomarker analysis, Other: assessment of therapy complications, Procedure: management of therapy complicationsPatients 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. |
| Arm 2 (CE) | Active comparator | Other: questionnaire administration, Procedure: quality-of-life assessment, Other: laboratory biomarker analysis, Other: assessment of therapy complications, Procedure: management of therapy complications, Other: educational interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Under age 18 (children with colorectal cancer)
- Unable to read or understand English
- Vulnerable subjects (except those who are economically or educationally disadvantaged)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga therapyreceive YST | Procedure or surgery | Arm 1 (YST) |
| questionnaire administrationAncillary studies | Other | Arm 1 (YST), Arm 2 (CE) |
| quality-of-life assessmentAncillary studies | Procedure or surgery | Arm 1 (YST), Arm 2 (CE) |
| laboratory biomarker analysisCorrelative studies | Other | Arm 1 (YST), Arm 2 (CE) |
| assessment of therapy complicationsAncillary studies | Other | Arm 1 (YST), Arm 2 (CE) |
| management of therapy complicationsAlso: complications of therapy, management ofReceive YST or CE | Procedure or surgery | Arm 1 (YST), Arm 2 (CE) |
| educational interventionReceive CE | Other | Arm 2 (CE) |
Primary outcome
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.
3 secondary outcomes
Preliminary efficacy of YST, in terms of reducing fatigue
Time frame: At week 8
Treatment related symptoms and QOL
Time frame: At week 8
Mediating variables (self efficacy, response expectancies, inflammatory biomarkers) intervention effect on fatigue, treatment-related symptoms, and QOL
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie J Sohl, PhD principal investigator
Wake Forest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga therapy, questionnaire administration and quality-of-life assessment in people with Fatigue and Nausea and Vomiting, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing a YST among patients undergoing chemotherapy (participating rate, adherence, and retention) (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.