Evaluation of the Efficacy of National Cancer Institute's Facing Forward Booklet in the Cancer Community Setting

Temple University Health System (TUHS)

Status: Completed

Conditions: Breast Cancer; Prostate Cancer; Thoracic Cancer; Colorectal Cancer

Treatments: Other: Facing Forward booklet; Other: CIS (Cancer Information Service) Information Sheet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01440855

U10CA101178-03 (U.S. NIH Grant/Contract)

IRB06803

Details and patient eligibility

About

This study was designed to provide a preliminary evaluation of the efficacy and usability of the 2004 revised version of the booklet, Facing Forward , Life After Cancer Treatment, (hereafter,Facing Forward) published by the National Cancer Institute. Facing Forward provides early stage cancer patients during the period after completing active treatment practical ways of dealing with common problems, including guidelines for managing physical, social, and emotional health. Assessments were completed at the patient's final cancer treatment visit. Follow-up assessments occurred eight weeks and 6 months later. The initial assessments covered background information (demographics, medical status), use of educational materials, survivorship activities, and psychological factors. The follow-up assessments included use of actions recommended in Facing Forward, ratings of Facing Forward with respect the booklet's informativeness, helpfulness, understandability, and extent read, the same psychological measures used initially, and a measure of self-efficacy.

Full description

This study was designed to provide a preliminary evaluation of the efficacy and usability of the 2004 revised version of the booklet, Facing Forward, Life After Cancer Treatment (hereafter,Facing Forward)published by the National Cancer Institute. Facing Forward provides early stage cancer patients during the period after completing active treatment practical ways of dealing with common problems, including guidelines for managing physical, social, and emotional health. The study employed a randomized controlled repeated measures design and compared Facing Forward with a control document published by the National Cancer Institute, The Cancer Information Service: Questions and Answers. The intervention arm received both Facing Forward and the control document and the control arm received only the latter. Assessments were completed at baseline, which occurred at the patient's final cancer treatment visit or alternatively at the first follow-up visit for those scheduled to be evaluated and/or restaged within 28 days of their last treatment visit. The first follow-up assessment occurred eight weeks following the baseline assessment via mail-home materials, and the second occurred 6 months following the baseline assessment, again via mail-home materials. Baseline measures included background information (demographics, medical status), use of educational materials, survivorship activities engaged in, and psychological factors. The 8-week and 6-month assessments included uptake of actions recommended in Facing Forward, and ratings of Facing Forward with respect to its usability, including the booklet's informativeness, helpfulness, understandability, and extent read, and the same psychological factors assessed at baseline.

Enrollment: 340 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• current age at or above 18 years;
• breast, colorectal, prostate, and/or thoracic cancer diagnosis,stage I, II, IIIa;
• approaching or attending the last treatment appointment of chemotherapy and or radiation therapy for the cancer diagnosis
• English speaking (able to read English at an 8th grade level);
• have a mailing address;
• have residential phone service;
• able to give informed consent.

Exclusion criteria

• patients who have received surgery only with no adjuvant therapy;
• second primary cancer or recurrent disease;
• patients receiving brachytherapy only

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

CIS Fact Sheet (CIS: Cancer Information Service)

Active Comparator group

Description:

CIS Fact Sheet, available on the Cancer Information Service website. Used to control for attention. 5-page document provides information about the CIS:What is it, How can CIS information specialists help me, How can I use CIS's services. Also includes definitions of glossary terms and a table of email and website addresses.

Treatment:

Other: CIS (Cancer Information Service) Information Sheet

Facing Forward booklet

Experimental group

Description:

NCI's Facing Forward 61-page booklet, which describes common feelings and reactions that cancer survivors experience during the re-entry phase and offers behavioral recommendations to help them through this period, i.e., ways of dealing with common problems and guidelines for managing physical, social, and emotional health. Booklet sections: Congratulations on Finishing Your Cancer Treatment, Getting Follow-up Medical Care, Ways to Manage Physical Changes, Body Changes and Intimacy, Your Feelings, Social and Work Relationships, Reflection, 6-page Appendix, which provides information on Financial and Legal Matters, and Resource Organizations.

Treatment:

Other: Facing Forward booklet