CancerNCT01718574
Bibliotherapy for Patients With Cancer
A study testing Self-help book in people with Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Self-help book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2013to Sep 2014
- 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
- 18+ years of age
- been diagnosed with cancer
- can read English
Who cannot join
- -participating in the "Think Smart, Live Well" group
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
MUHC Cedars CanSupport
Montreal, Quebec, H3A 1A1
Hope & Cope, JGH
Montreal, Quebec
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Self-help book
- Keywords
- self-help book, support service
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help bookOther
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
| Study group | Role | What they receive |
|---|---|---|
| Self-help book | Experimental | Not described Receives: Other: Self-help book |
| Usual Care Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Health Education Impact Questionnaire scores
Measured: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
Secondary outcomes (1)
change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores
Measured: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars CanSupport, Hope & Cope
- Responsible party
- Principal investigator, Dr. Annett Korner, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718574
- Sponsor's protocol ID
- 2888
- Status last verified
- Sep 2014
- First submitted
- 24 Oct 2012
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Efficacy of Bibliotherapy for Patients With Cancer: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01718574
- Acronym / sponsor ID
- 2888
- Conditions
- Cancer
- Keywords
- self-help book, support service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Cedars CanSupport, Hope & Cope
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Oct 2012 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help book | Experimental | Other: Self-help book |
| Usual Care Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age
- been diagnosed with cancer
- can read English
Key exclusion criteria (1 listed)
- -participating in the "Think Smart, Live Well" group
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 |
|---|---|---|
| Self-help bookParticipants 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 | Other | Self-help book |
Primary outcome
change in Health Education Impact Questionnaire scores
Time frame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
1 secondary outcome
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)
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 9 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help book in people with Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
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 3 inclusion and 1 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
change in Health Education Impact Questionnaire scores (time frame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)). 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 9 Sep 2014.