Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer

NCT00971919 | Unknown

• 2 other identifiers: EU-20926CDR0000639659
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer may help improve the quality of life for these patients and may help doctors plan the best treatment. PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for stage I, stage II, or stage III breast cancer.

Conditions

Breast Cancer; Pain; Perioperative/Postoperative Complications

Keywords

pain; perioperative/postoperative complications; breast cancer in situ; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (3)

• Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery

• Identification of which psychological and quality of life variables, after controlling for baseline demographic, surgical, and other factors, are predictive of chronic pain at 4 and 9 months after surgery

• Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline

Interventions

questionnaire administration OTHER

assessment of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer or carcinoma in situ of the breast by core biopsy or fine needle aspiration * Newly diagnosed disease * Stage I-III disease * Resectable disease * Being treated in the Aberdeen, Dundee, Perth, or Inverness Breast Unit * Planning to undergo primary surgical excision of the tumor (e.g., breast conservation surgery or mastectomy with or without axillary surgery \[sentinel node biopsy, axillary sample, or axillary clearance\]) * Planning to undergo standard adjuvant therapy after surgery, including radiotherapy, chemotherapy, and/or hormonal therapy, as per existing standard protocols * No detectable metastatic disease PATIENT CHARACTERISTICS: * Not pregnant * Speaks English * No history of mental illness PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aberdeen Royal Infirmary: lead

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pain; Postoperative Complications; Breast Carcinoma In Situ

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Julie Bruce, MD, PhD

  Aberdeen Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: March 1, 2007
• Primary Completion: May 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2009-09

Locations

GB (1)