跳至主要内容
临床试验/NCT01775085
NCT01775085
进行中(未招募)
不适用

Development of Group Interventions for Breast Cancer Survivors

Memorial Sloan Kettering Cancer Center2 个研究点 分布在 1 个国家目标入组 104 人2013年1月1日

概览

阶段
不适用
干预措施
manualized group intervention
疾病 / 适应症
Breast Cancer Survivor
发起方
Memorial Sloan Kettering Cancer Center
入组人数
104
试验地点
2
主要终点
feasibility as measured by the proportion of patients enrolled who complete 4 out of 8 modules, which should not be not lower than 40%.
状态
进行中(未招募)
最后更新
2个月前

概览

简要总结

The purpose of this study is to compare two types of groups for breast cancer survivors: a Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal with the emotional burden of having gone through the cancer experience. Participation in groups offering support often helps cancer survivors cope with stressors of life after having had cancer by giving them a place to express their feelings. The "Meaning-Centered Group" is intended to teach breast cancer survivors how to maintain or even increase a sense of meaning and purpose in their lives after treatment for cancer. The "Discussion Group" is intended to help breast cancer survivors cope by giving them a place to get support from other breast cancer survivors.

The goal of this study is to compare the benefits of these two types of group approaches for breast cancer survivors. The study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.

注册库
clinicaltrials.gov
开始日期
2013年1月1日
结束日期
2027年1月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

入排标准

入选标准

  • History of non-metastatic breast cancer (DCIS or Stage I, II, or III) as recorded in the medical record at MSKCC by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
  • Post completion of treatment (may be on hormone therapy, such as Tamoxifen or monoclonal antibody, such as Herceptin or Pertuzumab)) for any type of cancer as confirmed by the medical record at MSKCC, by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
  • Age 18 or older
  • Access to a telephone, computer (e.g. desktop, laptop, smartphone, tablet) and Internet
  • For Phase 2 only:
  • A score of ≥ to 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the patient's breast cancer or survivorship
  • If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or, confirmed by reports in the medical record at MSKCC, by selfreport, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
  • Did not participate in Phase 1

排除标准

  • Evidence of or treatment metastatic disease
  • Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the groups (i.e., acute psychiatric symptoms which require individual treatment).

研究组 & 干预措施

Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)

干预措施: manualized group intervention

Discussion Group (DG)

干预措施: standardized, manualized group intervention

结局指标

主要结局

feasibility as measured by the proportion of patients enrolled who complete 4 out of 8 modules, which should not be not lower than 40%.

时间窗: 2 years

研究点 (2)

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