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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01764789
Other study ID # OSU-10026
Secondary ID NCI-2012-01177R2
Status Completed
Phase N/A
First received January 8, 2013
Last updated October 8, 2015
Start date October 2010
Est. completion date January 2012

Study information

Verified date October 2015
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 85 Years
Eligibility 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)

Study Design

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


Related Conditions & MeSH terms

  • Anxiety Disorder
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Endometrial Neoplasms
  • Fatigue
  • Germinoma
  • Gestational Trophoblastic Disease
  • Leydig Cell Tumor
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Pain
  • Peritoneal Carcinomatosis
  • Peritoneal Neoplasms
  • 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
  • Sarcoma
  • Trophoblastic Neoplasms
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms

Intervention

Other:
questionnaire administration
Ancillary studies
Procedure:
quality-of-life assessment
Patients will participate in a quality life assessment.
psychosocial assessment and care
Participate in multi-component biobehavioral intervention
Behavioral:
behavioral intervention
Participate in multi-component biobehavioral intervention
Other:
cognitive intervention
A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer.
educational intervention
Participate in multi-component biobehavioral intervention

Locations

Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life(QoL) Quality of life as assessed by Short Form (SF)-36 up to 28 weeks No
Secondary Mood as assessed by the Profile of Mood States (POMS) Up to 28 weeks No
Secondary Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D) Up to 28 weeks No
Secondary Stress as assessed by the Impact of Event Scale (IES) Up to 28 weeks No
Secondary Pain as assessed by the Brief Pain Inventory (BPI) Up to 28 weeks No
Secondary Fatigue as assessed by the Fatigue Severity Index (FSI) Up to 28 weeks No
Secondary Diurnal cortisol slope Study participants will also collect saliva samples at home 4 times a day for 3 days. Saliva samples will be collected at the baseline, mid-treatment, post-treatment and 3-month follow-up assessments. These samples will be used to measure cortisol. Up to 28 weeks No
Secondary Inflammation Blood samples will be used to measure levels of inflammatory markers. Blood draws will be coordinated with the participants' regularly scheduled blood draws to minimize discomfort. Up to 28 weeks No
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