- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372840
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer
Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment
RATIONALE: Printed educational materials, such as the Facing Forward Series: Life After Cancer Treatment manual, may help make the transition from cancer patient to cancer survivor easier in patients who are finishing treatment for cancer. It is not yet known if the Facing Forward Series: Life After Cancer Treatment manual and The Cancer Information Service, Questions and Answers fact sheet is more effective than the The Cancer Information Service, Questions and Answers fact sheet alone in helping to make life after cancer treatment easier and to improve quality of life in patients with breast cancer, colorectal cancer, prostate cancer, or chest cancer.
PURPOSE: This randomized clinical trial is studying how well printed education materials work in assisting patients who are finishing treatment for stage I, stage II, or stage IIIA breast cancer, colorectal cancer, prostate cancer, or chest cancer to make the transition from cancer patient to cancer survivor easier.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Determine the efficacy of a psychoeducational intervention comprising a specific print intervention manual (Facing Forward Series: Life After Cancer Treatment [Facing Forward manual]) and a general print intervention fact sheet (The Cancer Information Service, Questions and Answers) vs the general print intervention fact sheet only on the uptake of recommended actions (e.g., developing a wellness plan after treatment, dealing with pain and fatigue, finding support groups to deal with feelings after treatment, and dealing with family issues after treatment) in patients completing active treatment for stage I-IIIA breast, prostate, colorectal, or thoracic cancer.
- Explore patient process evaluations of the Facing Forward manual in terms of its usability, comprehension, and satisfaction.
Secondary
- Examine psychological outcomes (i.e., depressive symptoms, fear of recurrence, health-related quality of life, and self-efficacy) as a function of exposure to the Facing Forward manual.
OUTLINE: This is a multicenter, randomized, controlled, open-label, cohort study. Patients are stratified according to participating center, prior chemotherapy (yes vs no), and type of cancer (breast vs colorectal vs prostate vs thoracic). Patients are randomized to 1 of 2 arms.
- Arm I (intervention): Patients receive a specific print intervention manual entitled Facing Forward Series: Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.
- Arm II (control): Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.
In both arms, patients are evaluated at baseline (within 18 days of the patient's final cancer treatment visit), 8 weeks (via mailed home materials), and then at 6 months (via mailed home materials). Baseline evaluations include background information (i.e., demographics and medical status), baseline use of educational materials, survivorship activities, and psychological factors (i.e., depressive symptoms, quality of life, fear of recurrence, and self-efficacy). Psychological factors are also reassessed at 8 weeks and 6 months, as well as use of educational materials and survivorship activities.
For patients in both arms, uptake of recommended actions are reassessed. Patients in arm I complete ratings of the Facing Forward Series: Life After Cancer Treatment manual usability, comprehension, and satisfaction at 8 weeks and 6 months.
PROJECTED ACCRUAL: A total of 332 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of breast, colorectal, prostate, or thoracic cancer*
- Stage I-III disease
- Approaching, attending, or already attended with the past 28 days, the last treatment appointment of chemotherapy and/or radiotherapy NOTE: *Stage IIIA disease for thoracic cancer and excluded mesothelioma; if small cell lung cancer is present must be limited stage disease
- No more than 1 primary cancer
- No recurrent disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- Able to speak/read English at an 8th grade level
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior brachytherapy only
- No prior surgery only (i.e., must have received prior adjuvant therapy and surgery)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive a specific print intervention manual entitled Facing Forward Series: Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.
|
|
Active Comparator: Arm II
Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uptake of recommended actions
Time Frame: 18 days, 8 weeks, 6 months after completion of treatment
|
18 days, 8 weeks, 6 months after completion of treatment
|
Number of sections of the Facing Forward manual read with satisfaction and comprehension
Time Frame: 18 days, 8 weeks, 6 months after completion of treatment
|
18 days, 8 weeks, 6 months after completion of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in psychological outcomes from baseline to 8-week follow-up
Time Frame: 8 weeks, 6 months after completion of treatment
|
8 weeks, 6 months after completion of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne M. Miller, PhD, Fox Chase Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IIIA breast cancer
- stage III prostate cancer
- stage IIIA non-small cell lung cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage II breast cancer
- stage I breast cancer
- limited stage small cell lung cancer
- psychosocial effects of cancer and its treatment
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III thymoma
- stage I rectal cancer
- stage I colon cancer
- stage IIA colon cancer
- stage IIB colon cancer
- stage IIC colon cancer
- stage IIIA colon cancer
- stage IIA rectal cancer
- stage IIB rectal cancer
- stage IIC rectal cancer
- stage IIIA rectal cancer
- pulmonary carcinoid tumor
- stage II malignant mesothelioma
- stage III malignant mesothelioma
- stage IA malignant mesothelioma
- stage IB malignant mesothelioma
- stage I thymoma
- stage II thymoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms, Complex and Mixed
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Breast Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
- Thymoma
- Thymus Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
Other Study ID Numbers
- FCCC-FCRB-04-002-P
- CDR0000464245 (Registry Identifier: PDQ (Physician Data Query))
- NCI-2009-00569 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- 06-803 (Other Identifier: FCCC IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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