Clinical trial NCT01440855: Evaluation of the Efficacy of National Cancer Institute's Facing Forward Booklet in the Cancer Community Setting
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Breast Cancer
Colorectal Cancer
Thoracic Cancer
Keywords: Survivorship
cancer control
psychosocial interventions
Facing Forward
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-27
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Reported uptake of behavioral actions recommended in Facing Forward
timeFrame: Baseline
measure: Reported uptake of behavioral actions recommended in Facing Forward
timeFrame: 8-weeks post-baseline
measure: Reported uptake of behavioral actions recommended in Facing Forward
timeFrame: 6-months post-baseline
Secondary outcomes:
measure: Usability of Facing Forward
timeFrame: Eight weeks post-baseline
measure: Usability of Facing Forward
timeFrame: 6 months post-baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Suzanne M Miller-Halegoua, PhD
role: PRINCIPAL_INVESTIGATOR
References: