Group Interventions for Breast Cancer Survivors

This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01775085
First received: January 21, 2013
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

Many cancer patients seek help to deal with the emotional burden of their illness. The purpose of this study is to compare two types of psychoeducational groups for breast cancer survivors: a meaning-centered group and a standardized support group. The study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.


Condition Intervention
Breast Cancer Survivor
Behavioral: manualized group intervention
Behavioral: standardized, manualized group intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development of Group Interventions for Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    as measured by the proportion of patients enrolled who complete 4 out of 8 modules, which should not be not lower than 40%.


Estimated Enrollment: 85
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS) Behavioral: manualized group intervention
MCG-BCS manual outlines 8, 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: Standard Support Group (SSG) Behavioral: standardized, manualized group intervention
SSG is a standardized, manualized group developed by the MSKCC Psychiatry Service and adapted into a psychoeducational education. Based on supportive care models described by Rogers and Bloch, the essential components include reassurance, explanation, psychoeducation, 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 psychoeducation about here-and-now topics relevant to BCS maintaining and eliciting social support, financial strains, return to work, physical symptom management), allowing emotional expression, and discussion of difficult topics.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775085

Contacts
Contact: Malwina Tuman, MS 646-888-0134
Contact: Corinne Sweeney, MA 646-888-0134

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States
Contact: Malwina Tuman     646-888-0134        
Contact: Corrine Sweeney     646-888-0134        
Principal Investigator: Wendy Lichtenthal, MD            
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Malwina Tuman, MS     646-888-0134        
Contact: Corrine Sweeney, MA     646-888-0134        
Principal Investigator: Wendy Lichtenthal, PhD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
American Cancer Society, Inc.
Investigators
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01775085     History of Changes
Other Study ID Numbers: 12-291
Study First Received: January 21, 2013
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013