Group Interventions for Breast Cancer Survivors
Primary Purpose
Breast Cancer Survivor
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
manualized group intervention
standardized, manualized group intervention
Sponsored by

About this trial
This is an interventional other trial for Breast Cancer Survivor focused on measuring Interventions, Meaning-Centered Group (MCG), Discussion Group (DG), Modules, Sessions, 12-291
Eligibility 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).
Sites / Locations
- Memorial Sloan Kettering Cancer Center at Commack
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)
Discussion Group (DG)
Arm Description
Outcomes
Primary Outcome Measures
feasibility as measured by the proportion of patients enrolled who complete 4 out of 8 modules, which should not be not lower than 40%.
Secondary Outcome Measures
Full Information
NCT ID
NCT01775085
First Posted
January 21, 2013
Last Updated
July 20, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01775085
Brief Title
Group Interventions for Breast Cancer Survivors
Official Title
Development of Group Interventions for Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivor
Keywords
Interventions, Meaning-Centered Group (MCG), Discussion Group (DG), Modules, Sessions, 12-291
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)
Arm Type
Experimental
Arm Title
Discussion Group (DG)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
manualized group intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standardized, manualized group intervention
Intervention Description
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique James, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center at Commack
City
Commack
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Group Interventions for Breast Cancer Survivors
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