Brief Title
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
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
Brief 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.
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.
Study Type
Interventional
Primary Outcome
Uptake of recommended actions
Secondary Outcome
Changes in psychological outcomes from baseline to 8-week follow-up
Condition
Breast Cancer
Intervention
educational intervention
Study Arms / Comparison Groups
Arm I
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
340
Start Date
May 2006
Completion Date
March 2013
Primary Completion Date
November 2010
Eligibility 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)
Gender
All
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Suzanne M. Miller, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00372840
Organization ID
FCCC-FCRB-04-002-P
Secondary IDs
CDR0000464245
Responsible Party
Sponsor
Study Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Suzanne M. Miller, PhD, Principal Investigator, Fox Chase Cancer Center
Verification Date
February 2020