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A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence


N/A
21 Years
85 Years
Open (Enrolling)
Female
Anxiety Disorder, Depression, Fatigue, Leydig Cell Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Pain, Peritoneal Carcinomatosis, Pseudomyxoma Peritonei, Recurrent Breast Cancer, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Cancer, Recurrent Gestational Trophoblastic Tumor, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Primary Peritoneal Cavity Cancer, Recurrent Uterine Sarcoma, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer

Thank you

Trial Information

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence


PRIMARY OBJECTIVES:

I. To refine the intervention. II. Test the acceptability, feasibility, and clinical
appropriateness of the intervention.

III. To provide a preliminary test of its efficacy.

OUTLINE:

Patients participate in a multi-component intervention based on cognitive and behavioral
principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote
hopefulness, and a problem solving approach which navigates around obstacles or generates
alternatives when goals become blocked. Additional topics may be covered as indicated by
clinical need and patients goals. Biobehavioral components include addressing social and
disease-specific quality of life, and pain education. Intensive treatment sessions continue
weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.

After completion of study treatment, patients are followed up at 28 weeks.


Inclusion Criteria:



- Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free
interval; second primary cancers do not meet this criterion

- English speaking

- Able and willing to give informed consent

- To be considered for the blood and saliva collection, women must fulfill the
following secondary criteria:

- Diagnosis of recurrent breast or ovarian cancer with any disease-free interval

Exclusion Criteria:

- Residence > 70 miles from research site

- Subnormal intellectual potential (diagnosis of mental retardation)

- Progressive neurological or chronic, progressive, debilitating condition (e.g.,
dementia)

- Non-ambulatory

- Life expectancy less than 160 days, per the treating oncologist

- Current suicide risk sufficient to preclude treatment on an outpatient basis

- Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Quality of life as assessed by Short Form (SF)-36

Outcome Time Frame:

up to 28 weeks

Safety Issue:

No

Principal Investigator

Barbara Andersen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OSU-10026

NCT ID:

NCT01764789

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Depression
  • Fatigue
  • Leydig Cell Tumor
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Pain
  • Peritoneal Carcinomatosis
  • Pseudomyxoma Peritonei
  • Recurrent Breast Cancer
  • Recurrent Cervical Cancer
  • Recurrent Endometrial Carcinoma
  • Recurrent Fallopian Tube Cancer
  • Recurrent Gestational Trophoblastic Tumor
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Primary Peritoneal Cavity Cancer
  • Recurrent Uterine Sarcoma
  • Recurrent Vaginal Cancer
  • Recurrent Vulvar Cancer
  • psychological intervention
  • breast cancer
  • gynecologic cancer
  • Anxiety Disorders
  • Breast Neoplasms
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue
  • Leydig Cell Tumor
  • Pseudomyxoma Peritonei
  • Trophoblastic Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Adenoma
  • Germinoma
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Gestational Trophoblastic Neoplasms
  • Sarcoma

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210