Mesothelioma Related Clinical Trials:
Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment



    - General Info     - Purpose     - Eligibility     - Contacts & Locations     - Additional Information


Status: Recruiting
Sponsors and Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00372840

Condition: Breast Cancer; Colorectal Cancer; Lung Cancer; Malignant Mesothelioma; Prostate Cancer; Psychosocial Effects/Treatment; Quality of Life; Thymoma and Thymic Carcinoma
Intervention: Procedure: educational intervention; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment


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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 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
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Uptake of recommended actions [ Designated as safety issue: No ]
  • Number of sections of the Facing Forward manual read with satisfaction and comprehension [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in psychological outcomes from baseline to 8-week follow-up [ Designated as safety issue: No ]

Estimated Enrollment:   332
Study Start Date:   May 2006

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 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.


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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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)

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372840
Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia     Recruiting
      Philadelphia, Pennsylvania, United States, 19111-2497
      Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi     215-728-4790        

Sponsors and Collaborators
Fox Chase Cancer Center CCOP Research Base
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Joanne Buzaglo, PhD     Fox Chase Cancer Center    

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Additional Information:

Publications:
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.
 

Study ID Numbers:   CDR0000464245, FCCC-FCRB-04-002-P
First Received:   September 6, 2006
Last Updated:   December 25, 2007
ClinicalTrials.gov Identifier:   NCT00372840
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma  
quality of life  
psychosocial effects/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

Study placed in the following topic categories:
Thoracic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Gastrointestinal Diseases
Colonic Diseases
Quality of Life
Urogenital Neoplasms
Rectal Diseases
Lung Neoplasms
Connective Tissue Diseases
Thymus Neoplasms
Rectal cancer
Breast Diseases
Non-small cell lung cancer
Digestive System Neoplasms
Skin Diseases
Breast Neoplasms
Genital Diseases, Male
Intestinal Diseases
Intestinal Neoplasms

Additional relevant MeSH terms:
Mesothelioma
Skin and Connective Tissue Diseases
Respiratory Tract Neoplasms
Male Urogenital Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Mesothelial
Neoplasms, Complex and Mixed

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