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临床试验/NCT00496106
NCT00496106已完成不适用

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

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2007年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
2
主要终点
To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Control Arm

Experimental

6 telephone counseling sessions

干预措施: Telephone counseling (Behavioral)

Control Arm

Experimental

6 telephone counseling sessions

干预措施: Telephone interview (Behavioral)

Usual Care Arm

Active Comparator

6 telephone counseling sessions

干预措施: Telephone counseling (Behavioral)

Usual Care Arm

Active Comparator

6 telephone counseling sessions

干预措施: Telephone interview (Behavioral)

结局指标

主要结局

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

时间窗: 10 years

次要结局

  • To evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received the PTC intervention, compared to usual care(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lari Wenzel

Professor of Medicine

University of California, Irvine

研究点 (2)

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