Last Updated: December 25, 2007

Verified by: National Cancer Institute (NCI), October 2007

Clinical Trial Phase: Phase 3 | Start Date: May 2006

Overall Status: Recruiting

Estimated Enrollment: 332

Brief Summary

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”

Condition Keyword(s):

• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Malignant Mesothelioma
• Prostate Cancer
• Psychosocial Effects/Treatment
• Quality of Life
• Thymoma and Thymic Carcinoma

Intervention(s):

• Procedure: educational intervention
• Procedure: psychosocial assessment and care
• Procedure: quality-of-life assessment

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 phase III 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 Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control

Detailed Clinical Trial 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 treatment 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.

Outcome Measures for this Clinical Trial

Primary:

• Uptake of recommended actions
• Number of sections of the Facing Forward manual read with satisfaction and comprehension

Secondary:

• Changes in psychological outcomes from baseline to 8-week follow-up

Criteria for Participation in this Clinical Trial

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)

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Fox Chase Cancer Center CCOP Research Base

Fox Chase Cancer Center - Philadelphia

Philadelphia Pennsylvania 19111-2497 United States

Overall Clinical Trial Officials and Contacts

Joanne Buzaglo, PhD Principal Investigator Fox Chase Cancer Center

Related Publications

References: Green BL, Krupnick JL, Rowland JH, Epstein SA, Stockton P, Spertus I, Stern N. Trauma history as a predictor of psychologic symptoms in women with breast cancer. J Clin Oncol. 2000 Mar;18(5):1084-93.

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00372840

Study ID Number: CDR0000464245

ClinicalTrials.gov Identifier: NCT00372840

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database

Clinical Trials Authorship and Review

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Labels: ClinicalTrial