Breast CancerNCT00905086
Psychosocial Adjustment After Radiation Therapy in Patients With Cancer
An observational study of Breast Cancer and Cognitive/Functional Effects, run by Case Comprehensive Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer
- What is being tested?
- questionnaire administration, cognitive assessment and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Psychosocial Adjustment During the Post-Radiation Treatment Transition
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.
Read the 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.
- Conditions
- Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Lung Cancer, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- questionnaire administration, cognitive assessment, psychosocial assessment and care, quality-of-life assessment
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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 or surgery
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 or surgery
At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between stress appraisal (as assessed by CAHS at baseline) and psychosocial adjustment (as assessed by PAIS-SR at 1 month after radiotherapy)
Measured: 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
Measured: 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
Measured: At 1 month after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Daly, PhD, RN, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterSusan Mazanec, RN, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905086
- Sponsor's protocol ID
- CASE3Z08
- Other IDs
- P30CA043703, CASE3Z08
- Status last verified
- Sep 2015
- First submitted
- 19 May 2009
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Adjustment During the Post-Radiation Treatment Transition
- ClinicalTrials.gov ID
- NCT00905086
- Acronym / sponsor ID
- CASE3Z08
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationTwo 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. | Other | – |
| cognitive assessmentPatients 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). | Procedure or surgery | – |
| psychosocial assessment and carePatients 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). | Procedure or surgery | – |
| quality-of-life assessmentAt 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment. | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Daly, PhD, RN principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Susan Mazanec, RN principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cognitive/Functional Effects, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.