Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors

Not Applicable

Completed

• Conditions: Cancer Survivor; Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment
• Interventions: Behavioral: telephone-based intervention; Other: questionnaire administration; Other: counseling intervention; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

• Registration Number: NCT00915889
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the well-being and quality of life of cervical cancer survivors.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in African-American, Latina-American, or European-American cervical cancer survivors.

Detailed Description

OBJECTIVES: I. To evaluate the utility of the 6 telephone sessions (low intensity: LiTx) and 8 telephone sessions (high intensity: HiTx) plus Survivorship Booklet designed to educate and improve awareness of the physical and psychological impact of cancer and increase knowledge of appropriate medical and psychosocial resources for women with cervical cancer. II. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve psychological functioning (decrease depression and anxiety) of women with cervical cancer. III. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve social functioning (family support and communication).

OUTLINE: Patients are clinically assigned to 1 of 2 groups. GROUP I: Patients receive a survivorship booklet in the mail that contains information about cervical cancer. Patients then receive a follow-up telephone call at 3 months to clarify any issues relevant to the survivorship booklet. GROUP II: Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

Within 6 months to 3 years of a cervical cancer diagnosis Diagnosed with stages 1-3 invasive cervical cancer Not diagnosed with another type of cancer No other major disabling medical or psychiatric condition Survivors within 6 months to 3 years post diagnosis are included Participants must be able to read and/or speak either English or Spanish Women will not be excluded based on the type of treatment received for their cervical cancer or a history of diagnosis of mild depression or anxiety

Exclusion Criteria

Women with metastatic disease Women with major medical conditions (e.g., stroke and degenerative illness) Survivors with moderate to severe depression or anxiety Asian participants Stage 0 disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	counseling intervention	Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.
Group II	telephone-based intervention	Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.
Group I	questionnaire administration	Patients receive a survivorship booklet in the mail that contains information about cervical cancer. Patients then receive a follow-up telephone call at 3 months to clarify any issues relevant to the survivorship booklet.
Group II	questionnaire administration	Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.
Group II	study of socioeconomic and demographic variables	Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.
Group II	psychosocial assessment and care	Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.

Primary Outcome Measures

Name	Time	Method
Utility of a psychosocial intervention in educating and improving awareness of the physical and psychological impact of cancer and in increasing knowledge about appropriate medical and psychosocial resources for cervical cancer survivors	12 months after study initiation
Utility of a psychosocial intervention in improving social functioning (i.e., family support and communication) among cervical cancer survivors	12 months after study initiation
Utility of a psychosocial intervention in improving psychological functioning (i.e., decreasing depression and anxiety) among cervical cancer survivors	12 months after study initiation

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States