Psychosocial Adjustment After Radiation Therapy in Patients With Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Psychosocial Adjustment During the Post-Radiation Treatment Transition |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | August 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
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Other: questionnaire administration
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Primary care clinic
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00905086 History of Changes |
| Other Study ID Numbers: | CASE3Z08, P30CA043703, CASE3Z08 |
| Study First Received: | May 19, 2009 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Case Comprehensive Cancer Center:
|
cognitive/functional effects psychosocial effects of cancer and its treatment stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage I colon cancer stage II colon cancer stage III colon cancer stage I rectal cancer |
stage II rectal cancer stage III rectal cancer stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer extensive stage small cell lung cancer limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Lung Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013