Psychosocial Adjustment After Radiation Therapy in Patients With Cancer

Breast Cancer Clinical Trial

Official title:

Psychosocial Adjustment During the Post-Radiation Treatment Transition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905086
• Other study ID #: CASE3Z08
• Secondary ID: P30CA043703CASE3
• Status: Completed
• Phase: N/A
• First received: May 19, 2009
• Last updated: September 29, 2015
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Cognitive/Functional Effects
• Colorectal Cancer
• Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• 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.

Procedure:
• 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).
• 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).
• quality-of-life assessment
At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between stress appraisal (as assessed by CAHS at baseline) and psychosocial adjustment (as assessed by PAIS-SR at 1 month after radiotherapy)		one month after radiotherapy	No
Primary	Relationship between stress appraisal and uncertainty, symptom distress, cancer stage, comorbidities, age, gender, race/ethnicity, and education at 2 weeks prior to completing radiotherapy		2 weeks prior to radiotherapy	No
Primary	Social support (as assessed by MOS-SSS) and self-efficacy (as assessed by CBI-L v2.0) as moderators of the relationship between cognitive appraisal and adjustment		At 1 month after completion of radiotherapy	No