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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Reported uptake of behavioral actions recommended in Facing Forward
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patients who have received surgery only with no adjuvant therapy;
- •second primary cancer or recurrent disease;
- •patients receiving brachytherapy only
研究组 & 干预措施
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.
干预措施: CIS (Cancer Information Service) Information Sheet (Other)
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.
干预措施: Facing Forward booklet (Other)
结局指标
主要结局
Reported uptake of behavioral actions recommended in Facing Forward
时间窗: 6-months post-baseline
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
时间窗: Baseline
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
时间窗: 8-weeks post-baseline
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?.
次要结局
- Usability of Facing Forward(6 months post-baseline)
- Usability of Facing Forward(Eight weeks post-baseline)