Clinical trial · Interventional
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
Stress-Immune Response and Cervical Cancer
- 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)
RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function. PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychosocial Telephone Counseling (PTC) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psychosocial Telephone Counseling (PTC)
- description
- Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, \~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.
- interventionNames
- Behavioral: Psychosocial Telephone Counseling (PTC)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Eligible patients are randomized to receive either psychosocial telephone counseling (PTC) or usual care. The usual care are were only contacted by the study team to collect data in an identical frame to subjects receiving PTC.
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
INCLUSION CRITERIA Disease Characteristics: * Diagnosis of cervical cancer between the past 3-15 months * Stage I-III disease * Completed therapy for cervical cancer ≥ 1 month ago * Not receiving ongoing treatment * More than 4 weeks since prior immunotherapy * More than 30 days since prior investigational drugs * No prior biological response modifier * No concurrent corticosteroids * No concurrent immunosuppressive therapy Patient Characteristics: * Resident of Orange, San Diego, or Imperial County in California * English or Spanish speaking * No serious acute or chronic illness * Has access to a telephone EXCLUSION CRITERIA Disease Characteristics: * Stage IV cervical carcinoma * Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment * Used investigational drugs within 30 days of execution of the informed consent * Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection * Patients with metastatic disease or ongoing treatment * Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators Patient Characteristics: * Non-English or Spanish speakers
References
Publications (0)
Data not yet available