Psychosocial Adjustment After Radiation Therapy in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00905086|
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : September 30, 2015
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cognitive/Functional Effects Colorectal Cancer Lung Cancer Prostate Cancer Psychosocial Effects of Cancer and Its Treatment||Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Psychosocial Adjustment During the Post-Radiation Treatment Transition|
|Study Start Date :||August 2008|
|Primary Completion Date :||February 2009|
|Study Completion Date :||May 2009|
Other: questionnaire administration
- Relationship between stress appraisal (as assessed by CAHS at baseline) and psychosocial adjustment (as assessed by PAIS-SR at 1 month after radiotherapy) [ Time Frame: one month after radiotherapy ]
- Relationship between stress appraisal and uncertainty, symptom distress, cancer stage, comorbidities, age, gender, race/ethnicity, and education at 2 weeks prior to completing radiotherapy [ Time Frame: 2 weeks prior to radiotherapy ]
- 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 [ Time Frame: At 1 month after completion of radiotherapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905086
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Barbara Daly, PhD, RN||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Principal Investigator:||Susan Mazanec, RN||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|