NCT00905086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

May 19, 2009

Last Update Submit

September 29, 2015

Conditions

Breast CancerCognitive/Functional EffectsColorectal CancerLung CancerProstate CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

cognitive/functional effectspsychosocial effects of cancer and its treatmentstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage I colon cancerstage II colon cancerstage III colon cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage I prostate cancerstage II prostate cancerstage III prostate cancerextensive stage small cell lung cancerlimited stage small cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Interventions

questionnaire administrationOTHER

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.

cognitive assessmentPROCEDURE

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 carePROCEDURE

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 assessmentPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsLung NeoplasmsProstatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Mental Status and Dementia TestsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

May 1, 2009

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

US(1)