CancerNCT01359072
Enhancing Coping Skills in Patients With Cancer
A study testing Self administered coping intervention in people with Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Approximately 30% of all patients with cancer report levels of psychological distress indicative of the need for psychological intervention. Research suggests that learning more adaptive coping strategies improves psychological adjustment to 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 administered coping intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Aug 2012
- 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,
- able to read English,
- a cancer patient presenting at the McGill University Health Centre (MUHC) interested in participating,
- willing to receive minimal therapist contact (by telephone) and self administered therapy,
- able to give their own consent.
Who cannot join
- currently receiving psychological/psychiatric treatment/counselling,
- indicate at the time of recruitment that they intend to seek psychological treatment elsewhere during the study period,
- a history of psychosis or bipolar disorder,
- substance abuse/dependence in last 6 months,
- taking psychotropic medication with altering dosages in the past 3 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre - Melanoma Clinic & Cedars CanSupport
Montreal, Quebec, H3A 1A1
About this study
Official title: Enhancing Coping Skills in Patients With Cancer - a Randomized Controlled Study
- Approximately 30% of all patients with cancer report levels of psychological distress indicative of the need for psychological intervention.
- Research suggests that learning more adaptive coping strategies improves psychological adjustment to cancer.
- It is imperative to develop cost-efficient, feasible psychosocial interventions.
- The aim is to test the efficacy of the self administered format of a psycho-educational intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for cancer patients.
It is hypothesized that:
- patients would show significant reductions in distress (i.e., depression and anxiety) over the 6-week treatment period, and that treatment would produce superior results compared to wait-list; patients would maintain or even increase their improvement up to 3 months following treatment.
- the treatment would enhance more adaptive coping strategies.
- greater self-reported adherence to the treatment/homework would be associated with symptom improvement, more autonomous self-regulation and higher perceived competence for adhering to the coping intervention program.
- Conditions
- Cancer
- Being tested
- Self administered coping intervention
- Keywords
- coping, psychological distress, self-administered intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self administered coping interventionOther
The self administered coping intervention (i.e. NUCARE workbook) aims to teach individuals how to cope with their cancer. The intervention embraces two major areas: (i) the enhancement of a sense of personal control; and (ii) the learning of emotional and instrumental coping responses. The approach emphasizes training in problem-solving, relaxation techniques, cognitive coping skills, goal setting, communication, social support and lifestyle factors. The didactic material of the Nucare program is comprised of a workbook containing 12 chapters addressing the above mentioned aspects.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Treatment | Experimental | Not described Receives: Other: Self administered coping intervention |
| Wait list | Experimental | Not described Receives: Other: Self administered coping intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
Measured: pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention
Secondary outcomes (1)
Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
Measured with The Ways of Coping Questionnaire - Cancer Version scale and the Hospital Anxiety and Depression Scale
Measured: pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: This study is currently terminated due to low recruitment rate.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 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
- Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal
- Responsible party
- Principal investigator, Dr. Annett Korner, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Annett Koerner, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359072
- Sponsor's protocol ID
- 10-327-PSY
- Status last verified
- Aug 2012
- First submitted
- 20 May 2011
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Coping Skills in Patients With Cancer - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01359072
- Acronym / sponsor ID
- 10-327-PSY
- Conditions
- Cancer
- Keywords
- coping, psychological distress, self-administered intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is currently terminated due to low recruitment rate.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 May 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.
- Approximately 30% of all patients with cancer report levels of psychological distress indicative of the need for psychological intervention.
- Research suggests that learning more adaptive coping strategies improves psychological adjustment to cancer.
- It is imperative to develop cost-efficient, feasible psychosocial interventions.
- The aim is to test the efficacy of the self administered format of a psycho-educational intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for cancer patients.
It is hypothesized that:
- patients would show significant reductions in distress (i.e., depression and anxiety) over the 6-week treatment period, and that treatment would produce superior results compared to wait-list; patients would maintain or even increase their improvement up to 3 months following treatment.
- the treatment would enhance more adaptive coping strategies.
- greater self-reported adherence to the treatment/homework would be associated with symptom improvement, more autonomous self-regulation and higher perceived competence for adhering to the coping intervention program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Treatment | Experimental | Other: Self administered coping intervention |
| Wait list | Experimental | Other: Self administered coping intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18+ years of age,
- able to read English,
- a cancer patient presenting at the McGill University Health Centre (MUHC) interested in participating,
- willing to receive minimal therapist contact (by telephone) and self administered therapy,
- able to give their own consent.
Key exclusion criteria (5 listed)
- currently receiving psychological/psychiatric treatment/counselling,
- indicate at the time of recruitment that they intend to seek psychological treatment elsewhere during the study period,
- a history of psychosis or bipolar disorder,
- substance abuse/dependence in last 6 months,
- taking psychotropic medication with altering dosages in the past 3 months.
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 administered coping interventionThe self administered coping intervention (i.e. NUCARE workbook) aims to teach individuals how to cope with their cancer. The intervention embraces two major areas: (i) the enhancement of a sense of personal control; and (ii) the learning of emotional and instrumental coping responses. The approach emphasizes training in problem-solving, relaxation techniques, cognitive coping skills, goal setting, communication, social support and lifestyle factors. The didactic material of the Nucare program is comprised of a workbook containing 12 chapters addressing the above mentioned aspects. | Other | Immediate Intervention Treatment, Wait list |
Primary outcome
Change in The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
Time frame: pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention
1 secondary outcome
Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
Time frame: pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention
Results and safety
The study was stopped early (reason given: This study is currently terminated due to low recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
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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.
Annett Koerner, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self administered coping intervention in people with Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 Aug 2012. 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 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 was stopped early (reason given: This study is currently terminated due to low recruitment rate.). Results are not available in the source record.
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 The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention (time frame: pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention). 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 22 Aug 2012.