- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01718574
Bibliotherapy for Patients With Cancer
September 5, 2014 updated by: Dr. Annett Korner, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Feasibility, Acceptability and Efficacy of Bibliotherapy for Patients With Cancer: a Randomized Control Trial
The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- MUHC Cedars CanSupport
-
Montreal, Quebec, Canada
- Hope & Cope, JGH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18+ years of age
- been diagnosed with cancer
- can read English
Exclusion Criteria:
-participating in the "Think Smart, Live Well" group
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Self-help book
|
Participants have 6 weeks to complete a 12 chapter self-help workbook.
The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses
|
|
NO_INTERVENTION: Usual Care Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change in Health Education Impact Questionnaire scores
Time Frame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
|
pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores
Time Frame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
|
pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
October 24, 2012
First Submitted That Met QC Criteria
October 30, 2012
First Posted (ESTIMATE)
October 31, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 9, 2014
Last Update Submitted That Met QC Criteria
September 5, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2888
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.