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临床试验/NCT00416780
NCT00416780已完成不适用

Psychobiological Pathways: Breast Cancer Interventions

Pittsburgh Mind-Body Center at Carnegie Mellon University0 个研究点目标入组 350 人开始时间: 2006年12月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350

研究概览

简要总结

RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.

详细描述

OBJECTIVES:

  • Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.
  • Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.
  • Evaluate the efficacy of these intervention in these patients.
  • Evaluate the nature and extent of coping strategies in these patients.
  • Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).

  • Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.
  • Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.
  • Arm III (control): Patients receive usual care and are not asked to attend any meetings.

All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Supportive Care

入排标准

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

入选标准

  • DISEASE CHARACTERISTICS:
  • Diagnosed with breast cancer
  • First-time diagnosis of stage I or II disease
  • No more than 2 months since prior breast cancer surgery
  • Initial diagnosis of stage IV disease
  • Distant recurrence of prior breast cancer
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • Reside within a 60-mile radius of the greater Pittsburgh metropolitan area
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

排除标准

  • 未提供

研究者

发起方
Pittsburgh Mind-Body Center at Carnegie Mellon University
申办方类型
Other

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