Cancer SurvivorNCT00915889
Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors
A study testing telephone-based intervention, counseling intervention and questionnaire administration in people with Cancer Survivor and Cervical Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cancer Survivor, Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- telephone-based intervention, counseling intervention and questionnaire administration
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2009to 1 May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: 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.
Read the 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.
- Being tested
- telephone-based intervention, counseling intervention, questionnaire administration, study of socioeconomic and demographic variables, psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, cancer survivor
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
Either 6 or 8 telephone educational sessions
counseling interventionOther
counseling and communications studies
questionnaire administrationOther
Ancillary studies
study of socioeconomic and demographic variablesOther
Ancillary Studies
psychosocial assessment and careProcedure or surgery
6 weeks or 8 weeks of psychoeducational telephone sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: telephone-based intervention; Other: counseling intervention; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after study initiation
Utility of a psychosocial intervention in improving psychological functioning (i.e., decreasing depression and anxiety) among cervical cancer survivors
Measured: 12 months after study initiation
Utility of a psychosocial intervention in improving social functioning (i.e., family support and communication) among cervical cancer survivors
Measured: 12 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study start5 Apr 2009
- Primary completion1 May 2012
- Study completion1 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimlin Ashing-Giwa, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915889
- Sponsor's protocol ID
- 06081
- Other IDs
- P30CA033572, CHNMC-06081, CDR0000642406
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2009
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Survivorship Among African-, European-, and Latina-American Survivors
- ClinicalTrials.gov ID
- NCT00915889
- Acronym / sponsor ID
- 06081
- Keywords
- psychosocial effects of cancer and its treatment, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Apr 2009
- Primary completion
- 1 May 2012 (actual)
- Study completion
- 1 May 2012 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: questionnaire administrationPatients 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 | Experimental | Behavioral: telephone-based intervention, Other: counseling intervention, Other: questionnaire administration, Other: study of socioeconomic and demographic variables, Procedure: psychosocial assessment and carePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone-based interventionEither 6 or 8 telephone educational sessions | Behavioural | Group II |
| counseling interventioncounseling and communications studies | Other | Group II |
| questionnaire administrationAncillary studies | Other | Group I, Group II |
| study of socioeconomic and demographic variablesAncillary Studies | Other | Group II |
| psychosocial assessment and care6 weeks or 8 weeks of psychoeducational telephone sessions | Procedure or surgery | Group II |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimlin Ashing-Giwa, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-based intervention, counseling intervention and questionnaire administration in people with Cancer Survivor and Cervical Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.