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Group Interventions for Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01775085
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
American Cancer Society, Inc.
University of Southern California
The New School for Social Research
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Survivor Behavioral: manualized group intervention Behavioral: standardized, manualized group intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of Group Interventions for Breast Cancer Survivors
Study Start Date : January 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS) Behavioral: manualized group intervention
MCG-BCS manual outlines 8 approximately, 90-minute modules: 1) Concepts & Sources of Meaning; 2) Identity, Cancer Survivorship, & Meaning; 3) Historical Sources of Meaning: Past Legacy; 4) Historical Sources of Meaning: Present & Future Legacy; 5) Attitudinal Sources of Meaning: Encountering Life's Limitations; 6) Creative Sources of Meaning: Creativity & Responsibility; 7) Experiential Sources of Meaning: Connecting with Life via Love, Beauty, & Humor; and 8) Transitions: Reflections & Hopes for the Future.

Active Comparator: Discussion Group (DG) Behavioral: standardized, manualized group intervention
DG is a standardized, manualized group developed by the MSKCC Psychiatry Service and utilized in a similar form in our completed and ongoing RCTs of MCGP. Based on models described by Rogers and Bloch, the essential components include reassurance, explanation, education, encouragement, and permission for expression. The process emphasizes Rogerian concepts (e.g., empathic understanding) and avoids techniques that are not exclusively supportive. The content focuses on education about here-and-now topics relevant to BCS (e.g., maintaining and eliciting social support, financial strains, return to work, physical symptom management), allowing emotional expression and discussion of difficult topics.




Primary Outcome Measures :
  1. feasibility as measured by the proportion of patients enrolled who complete 4 out of 8 modules, which should not be not lower than 40%. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775085


Locations
United States, New York
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
American Cancer Society, Inc.
University of Southern California
The New School for Social Research
Investigators
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01775085     History of Changes
Other Study ID Numbers: 12-291
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Interventions
Meaning-Centered Group (MCG)
Discussion Group (DG)
Modules
Sessions
12-291

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases