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Completed

NCT Number: NCT01764789

Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

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.

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Key information

Conditions

Anxiety Disorder Abdominal Neoplasms Adenocarcinoma Adenocarcinoma, Mucinous Adnexal Diseases Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Ovarian Epithelial Depression Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Fallopian Tube Diseases Fallopian Tube Neoplasms Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gestational Trophoblastic Disease Gonadal Disorders Leydig Cell Tumor Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Gonadal Tissue Neurologic Manifestations Ovarian Diseases Ovarian Neoplasms Ovarian Sarcoma Ovarian Stromal Cancer Pain Pathological Conditions, Signs and Symptoms Peritoneal Carcinomatosis Peritoneal Diseases Peritoneal Neoplasms Pregnancy Complications Pregnancy Complications, Neoplastic 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 Sertoli-Leydig Cell Tumor Sex Cord-Gonadal Stromal Tumors Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Testicular Diseases Testicular Neoplasms Trophoblastic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

21 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Patients will participate in a quality life assessment.

Other names: quality of life assessment, Ancillary studies

psychosocial assessment and care

Procedure

Participate in multi-component biobehavioral intervention

Other names: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies

behavioral intervention

Behavioral

Participate in multi-component biobehavioral intervention

Other names: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment

Cognitive Intervention

Other

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

Other

Participate in multi-component biobehavioral intervention

Other names: intervention, educational

Primary outcomes

  1. Quality of life(QoL)

    Time frame: up to 28 weeks

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

Secondary outcomes

  1. Mood as assessed by the Profile of Mood States (POMS)

    Time frame: Up to 28 weeks

  2. Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)

    Time frame: Up to 28 weeks

  3. Stress as assessed by the Impact of Event Scale (IES)

    Time frame: Up to 28 weeks

  4. Pain as assessed by the Brief Pain Inventory (BPI)

    Time frame: Up to 28 weeks

  5. Fatigue as assessed by the Fatigue Severity Index (FSI)

    Time frame: Up to 28 weeks

  6. Diurnal cortisol slope

    Time frame: Up to 28 weeks

    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.

  7. Inflammation

    Time frame: Up to 28 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2013
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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