Group Interventions for Breast Cancer Survivors
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
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
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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