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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01440855
First received: September 22, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Prostate Cancer
Breast Cancer
Colorectal Cancer
Thoracic Cancer
Other: CIS (Cancer Information Service) Information Sheet
Other: Facing Forward booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy and Feasibility of a Psychosocial Intervention Within CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment (CCOP:Community Clinical Oncology Program)

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Reported uptake of behavioral actions recommended in Facing Forward [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Items asked whether the respondent engaged in each recommended behavior (Yes or No); affirmative responses to the items comprising each subscale were summed to create four subscale scores:use of follow-up medical care (6 items; e.g., have you developed a wellness plan?), management of side effects of management (7 items; e.g., have you used any tips for regaining your appetite? ), uptake of stress management (8 items; e.g., have you used relaxation techniques? ), management of social and financial matters management (7 items; e.g., have you used suggested tips for dealing with family issues?.

  • Reported uptake of behavioral actions recommended in Facing Forward [ Time Frame: 8-weeks post-baseline ] [ Designated as safety issue: No ]
    Items asked whether the respondent engaged in each recommended behavior (Yes or No); affirmative responses to the items comprising each subscale were summed to create four subscale scores:use of follow-up medical care (6 items; e.g., have you developed a wellness plan?), management of side effects of management (7 items; e.g., have you used any tips for regaining your appetite? ), uptake of stress management (8 items; e.g., have you used relaxation techniques? ), management of social and financial matters management (7 items; e.g., have you used suggested tips for dealing with family issues?.

  • Reported uptake of behavioral actions recommended in Facing Forward [ Time Frame: 6-months post-baseline ] [ Designated as safety issue: No ]
    Items asked whether the respondent engaged in each recommended behavior (Yes or No); affirmative responses to the items comprising each subscale were summed to create four subscale scores:use of follow-up medical care (6 items; e.g., have you developed a wellness plan?), management of side effects of management (7 items; e.g., have you used any tips for regaining your appetite? ), uptake of stress management (8 items; e.g., have you used relaxation techniques? ), management of social and financial matters management (7 items; e.g., have you used suggested tips for dealing with family issues?.


Secondary Outcome Measures:
  • Usability of Facing Forward [ Time Frame: Eight weeks post-baseline ] [ Designated as safety issue: No ]
    Informativeness of booklet with respect to post-treatment challenges (8 items);confidence about the participant's ability to deal with each of the challenges (8 items);helpfulness (15 items)and understandability (15 items)of booklet as a whole and of 6 booklet sections and 3 appendices; likelihood of uptake(16 items)of engaging in behaviors recommended in booklet;whether (9 items) and extent to which (9 items)6 booklet sections and 3 appendices was read.

  • Usability of Facing Forward [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
    Informativeness of booklet with respect to post-treatment challenges (8 items);confidence about the participant's ability to deal with each of the challenges (8 items);helpfulness (15 items)and understandability (15 items)of booklet as a whole and of 6 booklet sections and 3 appendices; likelihood of uptake(16 items)of engaging in behaviors recommended in booklet;whether (9 items) and extent to which (9 items)6 booklet sections and 3 appendices was read.


Enrollment: 340
Study Start Date: February 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CIS Fact Sheet (CIS: Cancer Information Service)
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.
Other: CIS (Cancer Information Service) Information Sheet
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.
Experimental: Facing Forward booklet
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.
Other: Facing Forward booklet
NCI's (NCI: National Cancer Institute) 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440855

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Suzanne M Miller-Halegoua, PhD Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01440855     History of Changes
Other Study ID Numbers: IRB06803, U10CA101178-03
Study First Received: September 22, 2011
Last Updated: September 30, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
Survivorship
cancer control
psychosocial interventions
Facing Forward

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Prostatic Diseases
Rectal Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014