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| Sponsor: | Fox Chase Cancer Center CCOP Research Base |
|---|---|
| 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: | Randomized, Open Label, Active Control |
| 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
| Study ID Numbers: | CDR0000464245, FCCC-FCRB-04-002-P |
| Study First Received: | September 6, 2006 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00372840 History of Changes |
| 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 IIIB breast cancer stage IIIC breast cancer stage III colon cancer stage I prostate cancer stage II 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 II rectal cancer stage III rectal cancer invasive thymoma and thymic carcinoma noninvasive thymoma and thymic carcinoma pulmonary carcinoid tumor localized malignant mesothelioma |
|
Thoracic Neoplasms Prostatic Diseases Genital Neoplasms, Male Neoplasms, Mesothelial Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Rectal Diseases Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Thymus Neoplasms Breast Diseases Respiratory Tract Neoplasms Neoplasms by Histologic Type |
Digestive System Neoplasms Skin Diseases Breast Neoplasms Genital Diseases, Male Intestinal Diseases Intestinal Neoplasms Carcinoma Neoplasms Digestive System Diseases Lung Diseases Thymoma Mesothelioma Gastrointestinal Neoplasms Adenoma Prostatic Neoplasms |