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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372840
• Other study ID #: FCCC-FCRB-04-002-P
• Secondary ID: CDR0000464245NCI
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: March 2013

Study information

• Verified date: February 2020
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: March 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment
• Thymoma
• Thymoma and Thymic Carcinoma
• Thymus Neoplasms

Intervention

Other:
• educational intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of recommended actions		18 days, 8 weeks, 6 months after completion of treatment
Primary	Number of sections of the Facing Forward manual read with satisfaction and comprehension		18 days, 8 weeks, 6 months after completion of treatment
Secondary	Changes in psychological outcomes from baseline to 8-week follow-up		8 weeks, 6 months after completion of treatment