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

June 3, 2015 updated by: City of Hope Medical Center

Cervical Cancer Survivorship Among African-, European-, and Latina-American Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: questionnaire administration
Ancillary studies
Experimental: 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.
Other: questionnaire administration
Ancillary studies
Behavioral: telephone-based intervention
Either 6 or 8 telephone educational sessions
Other: counseling intervention
counseling and communications studies
Other: study of socioeconomic and demographic variables
Ancillary Studies
Procedure: psychosocial assessment and care
6 weeks or 8 weeks of psychoeducational telephone sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 months after study initiation
12 months after study initiation
Utility of a psychosocial intervention in improving psychological functioning (i.e., decreasing depression and anxiety) among cervical cancer survivors
Time Frame: 12 months after study initiation
12 months after study initiation
Utility of a psychosocial intervention in improving social functioning (i.e., family support and communication) among cervical cancer survivors
Time Frame: 12 months after study initiation
12 months after study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kimlin Ashing-Giwa, PhD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06081
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-06081
  • CDR0000642406 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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