NCT00915889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

5.5 years

First QC Date

June 5, 2009

Last Update Submit

June 3, 2015

Conditions

Cancer SurvivorCervical CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentstage IA cervical cancerstage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancercancer survivor

Outcome Measures

Primary Outcomes (3)

  • 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 psychological functioning (i.e., decreasing depression and anxiety) among 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

EXPERIMENTAL

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.

Behavioral: telephone-based interventionOther: counseling interventionOther: questionnaire administrationOther: study of socioeconomic and demographic variablesProcedure: psychosocial assessment and care

Interventions

telephone-based interventionBEHAVIORAL

Either 6 or 8 telephone educational sessions

Group II
counseling interventionOTHER

counseling and communications studies

Group II
questionnaire administrationOTHER

Ancillary studies

Group IGroup II
study of socioeconomic and demographic variablesOTHER

Ancillary Studies

Group II
psychosocial assessment and carePROCEDURE

6 weeks or 8 weeks of psychoeducational telephone sessions

Group II

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CounselingPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • Kimlin Ashing-Giwa, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 8, 2009

Study Start

November 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)