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Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer


Inclusion Criteria:



- patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a
breast cancer

- patient has had breast cancer surgery within the last twelve months

- patient and partner married or cohabitating

- patient and partner 18 years of age or older

- patient and partner speak and read English

- patient and partner can provide meaningful informed consent

- patient and partner do not have any chronic physical or cognitive illness that would
preclude participation in the group sessions

- couple lives within 2 hour commuting distance to the center from which they are
recruited

Exclusion criteria:

- patient is male

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Mental Health Inventory

Outcome Time Frame:

time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention

Safety Issue:

No

Principal Investigator

Sharon L Manne, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CA-65727

NCT ID:

NCT00940277

Start Date:

December 2007

Completion Date:

October 2015

Related Keywords:

  • Breast Cancer
  • women couples counseling groups support intervention marriage
  • Breast Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Cooper Health SystemVoorhees, New Jersey  08043
Christiana Care Health SystemNewark, Delaware  19713
Virtua Health SystemVoorhees, New Jersey  08043