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Ovarian CancerCXR01NCT00496106

Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes

A study testing Telephone counseling and Telephone interview in people with Ovarian Cancer, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to: 1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care. 2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care. 3. Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Telephone counseling and Telephone interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteUnited States
Study dates
Aug 2007to Feb 2011
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 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial

The purpose of the study is to:

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

The incidence and mortality rates for invasive cervical cancer in minority, low-income, and less educated women exceeds that for white, higher income, and better educated women. In southern California the incidence and mortality rates for cervical cancer are nearly twice that of non-Latina white women. Our preliminary work supports and extends the extant literature, noting that quality of life can be significantly disrupted among cervical cancer survivors, with qualitative differences in how Latina women experience cancer survivorship. However, there is a paucity of literature on interventions designed to assist cervical cancer survivors manage illness-specific stress and improve health behaviors. Our current NIH-funded work suggests that a six session psychosocial telephone counseling (PTC) intervention can improve QOL and decrease psychological distress, with accompanying intervention-induced neuroendocrine and immune parameter modulations which may be related to disease endpoints. In primary support of these significant biobehavioral findings, the project herein proposes to accomplish the following Specific Aims:

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

To achieve these aims the investigators will randomize patients ascertained through the two SEER cancer registries to PTC (N=125) or usual care (N=125), stratifying on English or Spanish language preference. Assessments will occur at baseline (9-20 months post diagnosis), and three and nine months post enrollment/baseline. Assessments will include evaluation of QOL (overall QOL, psychological distress, coping, social support, sexual functioning), health behaviors, neuroendocrine parameters dehydroepiandrosterone sulfate, growth hormone [DHEA-S, cortisol, GH] and immunologic parameters (natural killers [NK] cell activity, IL-5, interferon, human papillomavirus (HPV) E6/E7 peptides, IL-15, IL 10). This project has significant public health relevance for an important unstudied cancer survivor population, many of whom are poor and underserved. If effective, an intervention which could improve quality of life (QOL) and health behaviors, and enhance neuroendocrine and immune responses for women with cervical cancer could have significant implications toward disease recurrence or survival.

Conditions
Ovarian Cancer
Being tested
Telephone counseling, Telephone interview
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone counselingBehavioural

    6 telephone counseling sessions

  • Telephone interviewBehavioural

    telephone interview

Study groups in NCT00496106
Study groupRoleWhat they receive
Control ArmExperimental6 telephone counseling sessions
Receives: Behavioral: Telephone counseling; Behavioral: Telephone interview
Usual Care ArmActive comparator6 telephone counseling sessions
Receives: Behavioral: Telephone counseling; Behavioral: Telephone interview

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 10 years

Secondary outcomes (1)
  1. To evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received the PTC intervention, compared to usual care

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionAug 2010
  4. Study completionFeb 2011

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496106
Sponsor's protocol ID
2005-4526
Other IDs
R01CA118136-01A1
Acronym
CXR01
Status last verified
Mar 2019
First submitted
2 Jul 2007
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25713429

Questions about this trial

What is this clinical trial studying?

A study testing Telephone counseling and Telephone interview in people with Ovarian Cancer, run by University of California, Irvine 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?

The sponsor lists 1 inclusion and 4 exclusion criteria. 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 7 Mar 2019. 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?

To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00496106, which also lists 1 linked publication.

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 7 Mar 2019.

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