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Development of Group Interventions for Breast Cancer Survivors


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer Survivor

Thank you

Trial Information

Development of Group Interventions for Breast Cancer Survivors


Inclusion Criteria:



- History of early-stage breast cancer (DCIS and Stages I, II, IIIA/B, operable Stage
IIIC) 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

- >3 months from completion of treatment (may be on hormone therapy, such as tamoxifen)
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, and Internet

For Phase 2 only:

- A score of > or = 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 in dosage and use of that
medication for at least 8 weeks, as 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

Exclusion Criteria:

- Evidence of other type of cancer (current diagnosis or history of
recurrence/metastasis) EXCEPT basal or squamous cell carcinoma of the skin as
confirmed by the medical record at MSKCC, by self-report, or by outside
correspondence

- 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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

feasibility

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Wendy Lichtenthal, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-291

NCT ID:

NCT01775085

Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer Survivor
  • Interventions
  • Meaning-Centered Group (MCG)
  • Standardized Support Group (SSG)
  • Modules
  • Sessions
  • 12-291
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725