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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment

Conditions
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Breast Cancer, Colorectal Cancer, Lung Cancer, Malignant Mesothelioma, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Thymoma and Thymic Carcinoma

Intervention / Treatment
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* Other: educational intervention
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Other: educational intervention<br> <br> |
| Active Comparator: Arm II<br>Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers. | Procedure: psychosocial assessment and care<br> <br> Procedure: quality-of-life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of recommended actions |  | 18 days, 8 weeks, 6 months after completion of treatment | 
| Number of sections of the Facing Forward manual read with satisfaction and comprehension |  | 18 days, 8 weeks, 6 months after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in psychological outcomes from baseline to 8-week follow-up |  | 8 weeks, 6 months after completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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