N/A
N=44
Programs To Support You During Chemotherapy
Depression · Fatigue · Stage IIA Colorectal Cancer · Stage IIB Colorectal Cancer · Stage IIC Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02489422 ↗Enrolled (actual)
44
Serious AEs
15.9%
Results posted
May 2021
Primary outcome: Primary: Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) — 53.1; 56.8; 53.0; 57.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory Biomarker Analysis (Other); Questionnaire Administration (Other); Daily Survey Administration (Other); Yoga Skills Training (Behavioral); Attention Control (Behavioral); Actigraphy Assessment (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) |
53.1; 56.8; 53.0; 57.2; 51.1; 57.2 | — |
| SECONDARY Circadian Disruption (Daily) |
11.8; 11.9 | — |
| SECONDARY Circadian Disruption (Daily) |
11.8; 11.9 | — |
| SECONDARY Circadian Disruption (Recalled) |
19.6; 19.9; 24.1; 23.9; 19.8; 29.7 | — |
| SECONDARY Depressive Symptoms Assessed by PROMIS |
49.9; 51.4; 47.4; 51.2; 46.6; 50.5 | — |
| SECONDARY Fatigue (Daily) |
49.18; 53.27; 51.00; 53.29 | — |
| SECONDARY Depressive Symptoms (Daily) |
43.96; 45.49; 44.38; 44.58 | — |
| SECONDARY Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits |
0.58; 0.58 | — |
| SECONDARY Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits |
0.58; 0.58 | — |
| SECONDARY Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits |
0.87; 0.87 | — |
| SECONDARY Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits |
0.87; 0.87 | — |
| SECONDARY Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits |
1.01; 1.01 | — |
| SECONDARY Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits |
1.01; 1.01 | — |
| SECONDARY Psychological Stress Assessed by the Perceived Stress Scale (PSS) |
14.7; 16.5; 11.4; 13.7; 12.1; 12.3 | — |
| SECONDARY Psychological Stress Assessed by the PSS (Daily) |
1.34; 1.58; 1.69; 1.78 | — |
| SECONDARY Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily) |
10.51; 9.59; 10.53; 10.36 | — |
| SECONDARY Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory |
34.8; 34.2; 33.1; 30.6; 37.8; 39.3 | — |
| SECONDARY Minutes of Home Practice Completed |
11.2; 12.1 | — |
| SECONDARY Percent of Planned In Person Intervention Sessions Attended |
68; 72 | — |
| SECONDARY Number of Participants With Successful Qualitative Data Collection |
30 | — |
Summary
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
Eligibility Criteria
Inclusion Criteria
- Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
- Have an Eastern Cooperative Oncology Group performance status of =< 1
- Ability to understand and the willingness to sign and informed consent document in English
Exclusion Criteria
- Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
Data sourced from ClinicalTrials.gov (NCT02489422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.