Group Interventions for Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT01775085|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : November 8, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775085
|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|
|Principal Investigator:||Wendy Lichtenthal, PhD||Memorial Sloan Kettering Cancer Center|