Clinical trial · Interventional
Support for People Undergoing Chemotherapy
Study of Stress Management and Exercise Intervention During Cancer Chemotherapy
- 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)
Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients. This study seeks to evaluate the separate and combined effects of stress management training and exercise training on quality of life during chemotherapy treatment. Participants receive either a home-based, self-administered program in 1 of 3 types (stress management, exercise, or stress management + exercise) or usual care (reading materials). It is hypothesized that the combined program (stress management + exercise) will be significantly associated with better quality of life than the usual care group, the exercise only group, and the stress management only group. All participants are assessed at 3 timepoints: before they begin chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first infusion.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined stress management and exercise training | Behavioral | — | UNRESOLVED |
| Exercise Training | Behavioral | — | UNRESOLVED |
| Stress Management training | Behavioral | — | UNRESOLVED |
| Usual care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Active Control: Usual Care
- interventionNames
- Behavioral: Usual care
- type
- EXPERIMENTAL
- label
- 2
- description
- Stress Management Intervention
- interventionNames
- Behavioral: Stress Management training
- type
- EXPERIMENTAL
- label
- 3
- description
- Exercise Intervention
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: participants must: * Be diagnosed with cancer * Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks * Be ≥18 years of age or older * Have an ECOG performance status of 0, 1, or 2 * Be capable of speaking and reading English * Be able to provide informed consent Exclusion Criteria: * ECOG of 3 or greater * Presence of contraindications to participating in moderate intensity exercise including: 1. . metastases to weight-bearing sites (spine, pelvis, lower extremities) 2. . active infections 3. . cardiomyopathy or congestive heart failure 4. . severe pulmonary or ventilatory disease (FEV 1.0\<50%) 5. . large pleural effusions or pericardial effusions 6. . anemia (Hgb \<8g/dL) 7. . neutropenia (absolute neutrophil count \< 0.05 x 10(9th)/L) 8. . severe osteoporosis (\> 2.5 SD below age and gender norms) 9. . thrombocytopenia (platelets \< 20 x 10(9th)/L) 10. . hyponatremia (Na+ \< 130 mmol/L) 11. . hypokalemia (K+ ≤ 3.0 mmol/L) 12. . hypercalcemia (Ca++ \> 6.5 mmol/L) 13. . abnormal ECG 14. . sensorimotor deficits sufficient to impede unassisted walking * Receipt of intravenous chemotherapy administration in the past 2 months * Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications * Presence of other contraindications as determined by the attending oncologist and research staff
References
Publications (5)
- BACKGROUNDCourneya KS, Mackey JR, & Quinney HA. Neoplasms. In Myers, Herbert, Humphrey (eds): American College of Sports Medicine resources for clinical exercise physiology: musculoskeletal, neuromuscular, immunologic, and hematologic conditions. New York: Lippincott.
- BACKGROUNDCourneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093. PMID 12721239
- BACKGROUNDCourneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. doi: 10.1002/pon.658. PMID 12748973
- BACKGROUNDJacobsen PB, Meade CD, Stein KD, Chirikos TN, Small BJ, Ruckdeschel JC. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002 Jun 15;20(12):2851-62. doi: 10.1200/JCO.2002.08.301. PMID 12065562
- DERIVEDPhillips KM, Jim HS, Small BJ, Tanvetyanon T, Roberts WS, Jacobsen PB. Effects of self-directed stress management training and home-based exercise on stress management skills in cancer patients receiving chemotherapy. Stress Health. 2012 Dec;28(5):368-75. doi: 10.1002/smi.2450. Epub 2012 Sep 13. PMID 22972771