Trial Information

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

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.