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
NCT ID: NCT00372840
Last Updated: 2020-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
340 participants
INTERVENTIONAL
2006-05-31
2013-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Arm I
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.
educational intervention
Arm II
Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.
psychosocial assessment and care
quality-of-life assessment
Interventions
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educational intervention
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Exclusion Criteria
* 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)
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Suzanne M. Miller, PhD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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. doi: 10.1200/JCO.2000.18.5.1084.
Other Identifiers
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CDR0000464245
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00569
Identifier Type: REGISTRY
Identifier Source: secondary_id
06-803
Identifier Type: OTHER
Identifier Source: secondary_id
FCCC-FCRB-04-002-P
Identifier Type: -
Identifier Source: org_study_id
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