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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00372840
First received: September 6, 2006
Last updated: May 2, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

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 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.

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372840

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Suzanne M. Miller, PhD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00372840     History of Changes
Other Study ID Numbers: FCCC-FCRB-04-002-P, CDR0000464245, NCI-2009-00569
Study First Received: September 6, 2006
Last Updated: May 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 20, 2014