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| Sponsor: | Fox Chase Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00372840 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Colorectal Cancer Lung Cancer Malignant Mesothelioma Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Thymoma and Thymic Carcinoma |
Other: educational intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label |
| Official Title: | Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment |
| Estimated Enrollment: | 332 |
| Study Start Date: | May 2006 |
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast, colorectal, prostate, or thoracic cancer*
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Principal Investigator: | Suzanne M. Miller, PhD | Fox Chase Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00372840 History of Changes |
| Other Study ID Numbers: | CDR0000464245, FCCC-FCRB-04-002-P |
| Study First Received: | September 6, 2006 |
| Last Updated: | January 12, 2012 |
| Health Authority: | United States: Federal Government |
|
psychosocial effects of cancer and its treatment stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIA colon cancer stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer limited stage small cell lung cancer stage I rectal cancer stage IIA rectal cancer |
stage IIB rectal cancer stage IIC rectal cancer stage IIIA rectal cancer pulmonary carcinoid tumor stage I thymoma stage II thymoma stage III thymoma stage I colon cancer stage IIA colon cancer stage IIB colon cancer stage IIC colon cancer stage IA malignant mesothelioma stage IB malignant mesothelioma stage II malignant mesothelioma stage III malignant mesothelioma |
|
Breast Neoplasms Carcinoma Colorectal Neoplasms Lung Neoplasms Mesothelioma Prostatic Neoplasms Thymoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type 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 Adenoma Neoplasms, Mesothelial Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |