Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment
About this trial
This is an interventional other trial for Cervical Cancer focused on measuring psychosocial effects of cancer and its treatment, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer
Eligibility Criteria
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
Sites / Locations
- UCI, Health Policy and Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Psychosocial Telephone Counseling (PTC)
Usual Care
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.
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.