Psychosocial Adjustment After Radiation Therapy in Patients With Cancer

NCT ID: NCT00905086

Last Updated: 2015-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-05-31

Brief Summary

RATIONALE: Gathering information about psychological and social adjustment after radiation therapy in patients with cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying psychosocial adjustment after radiation therapy in patients with breast cancer, colorectal cancer, lung cancer, or prostate cancer.

Detailed Description

OBJECTIVES:

• To describe psychosocial adjustment after radiotherapy in patients with stage I, II, or III breast, colorectal, lung, or prostate cancer.
• To determine if cognitive appraisal of health predicts psychosocial adjustment of these patients after radiotherapy.
• To examine whether social support moderates the relationship between cognitive appraisal of health and psychosocial adjustment of these patients after radiotherapy.
• To examine whether self-efficacy for coping with cancer moderates the relationship between cognitive appraisal of health and psychosocial adjustment of these patients after radiotherapy.
• To measure the effect of symptom distress, uncertainty, medical factors, and personal factors on cognitive appraisal of health of these patients before ending radiotherapy.

OUTLINE: Two weeks before completing planned radiotherapy, patients undergo assessment of stress appraisal and other factors predictive of post-radiotherapy psychosocial adjustment. Patients complete psychosocial assessments, including measures of patient perceptions of their illness (i.e., cognitive appraisal) and of the factors influencing their perceptions (i.e., uncertainty by the Mishel Uncertainty in Illness Scale-Community Form; symptom distress by the Memorial Symptom Assessment Scale Short Form; and comorbidity by the Charlson Comorbidity Index). Measures of patient social support and self-efficacy for coping are also assessed. At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.

Conditions

Breast Cancer; Cognitive/Functional Effects; Colorectal Cancer; Lung Cancer; Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

questionnaire administration

Two weeks before completing planned radiotherapy, patients undergo assessment of stress appraisal and other factors predictive of post-radiotherapy psychosocial adjustment. At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.

Intervention Type: OTHER

cognitive assessment

Patients complete psychosocial assessments, including measures of patient perceptions of their illness (i.e., cognitive appraisal) and of the factors influencing their perceptions (i.e., uncertainty by the Mishel Uncertainty in Illness Scale-Community Form; symptom distress by the Memorial Symptom Assessment Scale Short Form; and comorbidity by the Charlson Comorbidity Index).

Intervention Type: PROCEDURE

psychosocial assessment and care

Patients complete psychosocial assessments, including measures of patient perceptions of their illness (i.e., cognitive appraisal) and of the factors influencing their perceptions (i.e., uncertainty by the Mishel Uncertainty in Illness Scale-Community Form; symptom distress by the Memorial Symptom Assessment Scale Short Form; and comorbidity by the Charlson Comorbidity Index).

Intervention Type: PROCEDURE

quality-of-life assessment

At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast, colorectal, lung, or prostate cancer

• Stage I, II, or III disease
• Nonmetastatic disease
• Undergoing first course of curative radiotherapy, as indicated in the medical record

• Receiving treatment as an outpatient
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Able to receive treatment as an outpatient
• Lives in northeastern Ohio
• Cognitively intact, as evidenced by orientation to person, place, and time
• Has a telephone
• No hearing impairment (must be able to hear instructions)
• No malignancy expected to require surgery or chemotherapy ≤ 2 months after treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy for another type of cancer
• No concurrent or planned chemotherapy or surgery for at least 2 months after radiotherapy
• No concurrent treatment for recurrent cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Daly, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Susan Mazanec, RN

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE3Z08

Identifier Type: OTHER

Identifier Source: secondary_id

CASE3Z08

Identifier Type: -

Identifier Source: org_study_id