NCT00496106

Brief Summary

The purpose of the study is to:

  1. 1.Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care.
  2. 2.Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
  3. 3.Examine the longitudinal relationship between PTC associated modulations of quality of life (QOL) measures and biologic parameters (immune and neuroendocrine).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P50-P75 for not_applicable ovarian-cancer

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable ovarian-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

July 2, 2007

Last Update Submit

March 5, 2019

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care

    10 years

Secondary Outcomes (1)

  • To evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received the PTC intervention, compared to usual care

    10 years

Study Arms (2)

Control Arm

EXPERIMENTAL

6 telephone counseling sessions

Behavioral: Telephone counselingBehavioral: Telephone interview

Usual Care Arm

ACTIVE COMPARATOR

6 telephone counseling sessions

Behavioral: Telephone counselingBehavioral: Telephone interview

Interventions

Telephone counselingBEHAVIORAL

6 telephone counseling sessions

Control ArmUsual Care Arm
Telephone interviewBEHAVIORAL

telephone interview

Control ArmUsual Care Arm

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cervical cancer (stage I, II, or III) patients who have completed definitive treatment at least 2 months earlier and who were diagnosed between 9 and 20 months prior to enrollment.

You may not qualify if:

  • Stage IV cervical cancer.
  • Have undergone previous treatment with biological response modifier or prior immunotherapy within 4 weeks of study enrollment.
  • Used investigational drugs within 30 days.
  • Were under immune suppression for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

  • Wenzel L, Osann K, Hsieh S, Tucker JA, Monk BJ, Nelson EL. Psychosocial telephone counseling for survivors of cervical cancer: results of a randomized biobehavioral trial. J Clin Oncol. 2015 Apr 1;33(10):1171-9. doi: 10.1200/JCO.2014.57.4079. Epub 2015 Feb 23.

    PMID: 25713429DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lari B Wenzel, PhD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 4, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2010

Study Completion

February 1, 2011

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

US(1)