Clinical trial · Interventional
Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes
Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial
- 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)
The purpose of the study is to: 1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care. 2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care. 3. Examine the longitudinal relationship between PTC associated modulations of quality of life (QOL) measures and biologic parameters (immune and neuroendocrine).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telephone counseling | Behavioral | — | UNRESOLVED |
| Telephone interview | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control Arm
- description
- 6 telephone counseling sessions
- interventionNames
- Behavioral: Telephone counseling
- Behavioral: Telephone interview
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Arm
- description
- 6 telephone counseling sessions
- interventionNames
- Behavioral: Telephone counseling
- Behavioral: Telephone interview
Primary outcomes (1)
- measure
- To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Cervical cancer (stage I, II, or III) patients who have completed definitive treatment at least 2 months earlier and who were diagnosed between 9 and 20 months prior to enrollment. Exclusion Criteria: * Stage IV cervical cancer. * Have undergone previous treatment with biological response modifier or prior immunotherapy within 4 weeks of study enrollment. * Used investigational drugs within 30 days. * Were under immune suppression for any reason.
References
Publications (1)
- DERIVEDWenzel L, Osann K, Hsieh S, Tucker JA, Monk BJ, Nelson EL. Psychosocial telephone counseling for survivors of cervical cancer: results of a randomized biobehavioral trial. J Clin Oncol. 2015 Apr 1;33(10):1171-9. doi: 10.1200/JCO.2014.57.4079. Epub 2015 Feb 23. PMID 25713429