Clinical trial · Interventional
Programs to Support You During Chemotherapy (Pro-You)
Programs to Support You During Chemotherapy (Pro-You): Feasibility
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.
Conditions
Conditions (19)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depressive Symptoms | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Stage IIA Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Colon Cancer | Malignant Colon Neoplasm |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control | Other | — | UNRESOLVED |
| fatigue and depressive symptom assessment and management | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| psychological stress assessment | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| Yoga Skills Training (YST) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (YST intervention)
- description
- Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients review a handout describing the YST and to encourage patients to practice daily with strategies to increase adherence to home practice. Patients also receive an audio recording of the YST and devices to play the recording and are asked to keep a home practice log.
- interventionNames
- Behavioral: Yoga Skills Training (YST)
- Other: questionnaire administration
- Other: fatigue and depressive symptom assessment and management
- Other: psychological stress assessment
- Other: laboratory biomarker analysis
- type
- ACTIVE_COMPARATOR
- label
- Arm II (attention control)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 * Ability to understand and the willingness to sign an informed consent document written in English Exclusion Criteria: * Regularly engaged (\>= 3 days/week) in moderate physical activity of any kind (e.g., yoga) over the past 4 weeks * Has a self-reported history of diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia), comorbidities associated with poor sleep or fatigue (e.g., chronic fatigue syndrome), or a job with night shifts
References
Publications (0)
Data not yet available