Group Interventions for Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 21, 2014
Last verified: August 2014

January 21, 2013
August 21, 2014
January 2013
January 2015   (final data collection date for primary outcome measure)
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%.
feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
as measured by the proportion of patients enrolled who complete 4 out of 8 sessions, which should not be not lower than 40%.
Complete list of historical versions of study NCT01775085 on ClinicalTrials.gov Archive Site
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Group Interventions for Breast Cancer Survivors
Development of Group Interventions for Breast Cancer Survivors

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Breast Cancer Survivor
  • 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.
  • 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.
  • Experimental: Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)
    Intervention: Behavioral: manualized group intervention
  • Active Comparator: Discussion Group (DG)
    Intervention: Behavioral: standardized, manualized group intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
January 2015
January 2015   (final data collection date for primary outcome measure)

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
  • >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 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:

  • Current evidence of, treatment for, or a history of recurrence/metastasis of an other type of cancer 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).
Female
18 Years and older
No
Contact: Malwina Tuman, MS 646-888-0134
Contact: Corinne Sweeney, MA 646-888-0134
United States
 
NCT01775085
12-291
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
American Cancer Society, Inc.
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP