Group Interventions for Breast Cancer Survivors

NCT01775085 | Active Not Recruiting

• 1 other identifier: 12-291
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Survivor

Keywords

Interventions; Meaning-Centered Group (MCG); Discussion Group (DG); Modules; Sessions; 12-291

Outcome Measures

Primary Outcomes (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%.

  2 years

Study Arms (2)

Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)

EXPERIMENTAL

Behavioral: manualized group intervention

Discussion Group (DG)

ACTIVE COMPARATOR

Behavioral: standardized, manualized group intervention

Interventions

manualized group intervention BEHAVIORAL

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.

Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS)

standardized, manualized group intervention BEHAVIORAL

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.

Discussion Group (DG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Monique James, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (2)