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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA078084-07 | U.S. NIH Grant/Contract | View source | |
| IRB#07-831 | Other Identifier | Fox Chase Cancer Center |
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| Name | Class |
|---|---|
| Christiana Care Health Services | OTHER |
| Abington Memorial Hospital | OTHER |
| Albert Einstein College of Medicine | OTHER |
| The Cooper Health System |
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The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.
The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.
The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Couples Group | Experimental | Enhanced Couples Group: consists of eight 90-minute sessions, conducted weekly. ECG has a didactic educational content presented by the group leader or practice of specific relationship communication, relationship support, and couple-focused stress management. ECG participants are also given instruction about what types of behaviors are unsupportive and training in how to not behave in an unsupportive manner. |
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| Support Group | Experimental | Support Group: 8 weekly 90-minute group counseling sessions. Using a standard approach to supportive therapy, the group interventionists will focus on encouraging participants to share their experiences with cancer, express their emotions related to the experience, voice problems they have in coping with the cancer, and offer support and advice to other members of the group. The co-facilitators will facilitate expression of affect and the sharing of the group's common issues related to cancer. Each session has a broad topic for discussion. Topics include communication with health care providers, issues related to occupational life, and coping with medical procedures and treatment. No formal or didactic information will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Counseling | Behavioral | Group counseling |
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| Measure | Description | Time Frame |
|---|---|---|
| Mental Health Inventory | time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention | |
| Impact of Events Scale-Revised | baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention | |
| Well-being Subscale of the Mental Health Inventory (MHI) | baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Outcomes Survey (MOS SF-36) | baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention | |
| Adherence to Chemotherapy | 1 yr follow-up | |
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Inclusion Criteria:
Exclusion criteria:
- patient is male
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Manne, PhD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health System | Newark | Delaware | 19713 | United States | ||
| Cooper Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24611691 | Result | Manne S, Kashy DA, Siegel S, Myers Virtue S, Heckman C, Ryan D. Unsupportive partner behaviors, social-cognitive processing, and psychological outcomes in couples coping with early stage breast cancer. J Fam Psychol. 2014 Apr;28(2):214-24. doi: 10.1037/a0036053. Epub 2014 Mar 10. | |
| 25242854 | Result | Manne SL, Siegel S, Kashy D, Heckman CJ. Cancer-specific Relationship Awareness, Relationship Communication, and Intimacy Among Couples Coping with Early Stage Breast Cancer. J Soc Pers Relat. 2014 May;31(3):314-334. doi: 10.1177/0265407513494950. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OTHER |
| Virtua Health | OTHER |
| City University of New York, School of Public Health | OTHER |
| National Cancer Institute (NCI) | NIH |
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| Adherence to Radiation Therapy |
| 1 yr follow-up |
| Voorhees Township |
| New Jersey |
| 08043 |
| United States |
| Virtua Health System | Voorhees Township | New Jersey | 08043 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19001 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Result | Manne, S. & Ostroff, J. (2011). Couple-focused group intervention for women diagnosed with early stage breast cancer and their partners. In. D. Kissane & M Watson (Eds.), IPOS Academy Handbook of Psychotherapies in Cancer Care. (pp. 129-139). Chichester, UK: Wiley. |
| D017437 |
| Skin and Connective Tissue Diseases |