Clinical trial NCT00905086: Psychosocial Adjustment After Radiation Therapy in Patients With Cancer
Official title: Psychosocial Adjustment During the Post-Radiation Treatment Transition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cognitive/Functional Effects
Colorectal Cancer
Lung Cancer
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

Eligibility 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

Primary outcomes:
measure: Relationship between stress appraisal (as assessed by CAHS at baseline) and psychosocial adjustment (as assessed by PAIS-SR at 1 month after radiotherapy)
timeFrame: one month after radiotherapy
measure: Relationship between stress appraisal and uncertainty, symptom distress, cancer stage, comorbidities, age, gender, race/ethnicity, and education at 2 weeks prior to completing radiotherapy
timeFrame: 2 weeks prior to radiotherapy
measure: 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
timeFrame: At 1 month after completion of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Barbara Daly, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Susan Mazanec, RN
role: PRINCIPAL_INVESTIGATOR
References: