Prostate CancerNCT01440855
Evaluation of the Efficacy of National Cancer Institute's Facing Forward Booklet in the Cancer Community Setting
A study testing CIS (Cancer Information Service) Information Sheet and Facing Forward booklet in people with Prostate Cancer and Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- CIS (Cancer Information Service) Information Sheet and Facing Forward booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients who have received surgery only with no adjuvant therapy;
- second primary cancer or recurrent disease;
- patients receiving brachytherapy only
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer, Breast Cancer, Colorectal Cancer, Thoracic Cancer
- Being tested
- CIS (Cancer Information Service) Information Sheet, Facing Forward booklet
- Keywords
- Survivorship, cancer control, psychosocial interventions, Facing Forward
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIS (Cancer Information Service) Information SheetOther
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.
Facing Forward bookletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CIS Fact Sheet (CIS: Cancer Information Service) | Active comparator | 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. Receives: Other: CIS (Cancer Information Service) Information Sheet |
| Facing Forward booklet | Experimental | 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. Receives: Other: Facing Forward booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported uptake of behavioral actions recommended in Facing Forward
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?.
Measured: Baseline
Reported uptake of behavioral actions recommended in Facing Forward
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?.
Measured: 8-weeks post-baseline
Reported uptake of behavioral actions recommended in Facing Forward
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?.
Measured: 6-months post-baseline
Secondary outcomes (2)
Usability of Facing Forward
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.
Measured: Eight weeks post-baseline
Usability of Facing Forward
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.
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startFeb 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne M Miller-Halegoua, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440855
- Sponsor's protocol ID
- IRB06803
- Other IDs
- U10CA101178-03
- Status last verified
- Sep 2011
- First submitted
- 22 Sep 2011
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01440855
- Acronym / sponsor ID
- IRB06803
- Conditions
- Prostate Cancer, Breast Cancer, Colorectal Cancer, Thoracic Cancer
- Keywords
- Survivorship, cancer control, psychosocial interventions, Facing Forward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIS Fact Sheet (CIS: Cancer Information Service) | Active comparator | Other: CIS (Cancer Information Service) Information SheetCIS 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. |
| Facing Forward booklet | Experimental | Other: Facing Forward bookletNCI'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- patients who have received surgery only with no adjuvant therapy;
- second primary cancer or recurrent disease;
- patients receiving brachytherapy only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIS (Cancer Information Service) Information SheetCIS 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 Fact Sheet (CIS: Cancer Information Service) |
| Facing Forward bookletNCI'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. | Other | Facing Forward booklet |
Primary outcome
Reported uptake of behavioral actions recommended in Facing Forward
Time frame: 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
Time frame: 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?.
Reported uptake of behavioral actions recommended in Facing Forward
Time frame: 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?.
2 secondary outcomes
Usability of Facing Forward
Time frame: Eight weeks post-baseline
Usability of Facing Forward
Time frame: 6 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne M Miller-Halegoua, PhD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIS (Cancer Information Service) Information Sheet and Facing Forward booklet in people with Prostate Cancer and Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported uptake of behavioral actions recommended in Facing Forward (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.