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Group Interventions for Breast Cancer Survivors

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Active, not recruiting

Conditions

Breast Cancer Survivor

Treatments

Behavioral: manualized group intervention
Behavioral: standardized, manualized group intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)
Experimental group
Treatment:
Behavioral: manualized group intervention
Discussion Group (DG)
Active Comparator group
Treatment:
Behavioral: standardized, manualized group intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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