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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00915889
First received: June 5, 2009
Last updated: March 7, 2013
Last verified: March 2013

June 5, 2009
March 7, 2013
November 2006
May 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Utility of a psychosocial intervention in improving psychological functioning (i.e., decreasing depression and anxiety) among cervical cancer survivors [ Designated as safety issue: No ]
  • Utility of a psychosocial intervention in improving social functioning (i.e., family support and communication) among cervical cancer survivors [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00915889 on ClinicalTrials.gov Archive Site
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Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cancer Survivor
  • Cervical Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Behavioral: telephone-based intervention
    Either 6 or 8 telephone educational sessions
  • Other: counseling intervention
    counseling and communications studies
  • Other: questionnaire administration
    Ancillary studies
  • Other: study of socioeconomic and demographic variables
    Ancillary Studies
  • Procedure: psychosocial assessment and care
    6 weeks or 8 weeks of psychoeducational telephone sessions
  • 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.
    Intervention: Other: questionnaire administration
  • 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.
    Interventions:
    • Behavioral: telephone-based intervention
    • Other: counseling intervention
    • Other: questionnaire administration
    • Other: study of socioeconomic and demographic variables
    • Procedure: psychosocial assessment and care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
Not Provided
May 2012   (final data collection date for primary outcome measure)

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

Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00915889
06081, P30CA033572, CHNMC-06081, CDR0000642406
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Kimlin Ashing-Giwa, PhD City of Hope Medical Center
City of Hope Medical Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP