- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01359072
Enhancing Coping Skills in Patients With Cancer
August 21, 2012 updated by: Dr. Annett Korner, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
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
- McGill University Health Centre - Melanoma Clinic & Cedars CanSupport
-
-
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,
- 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.
Exclusion Criteria:
- 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.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention Treatment
|
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.
|
Experimental: Wait list
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measured with The Ways of Coping Questionnaire - Cancer Version scale and the Hospital Anxiety and Depression Scale
|
pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Annett Koerner, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
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
June 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 20, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimate)
May 24, 2011
Study Record Updates
Last Update Posted (Estimate)
August 22, 2012
Last Update Submitted That Met QC Criteria
August 21, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 10-327-PSY
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.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on Self administered coping intervention
-
Ohio UniversityNational Institute of Mental Health (NIMH)CompletedDepression | HIV InfectionsUnited States
-
Universidad Nacional de RosarioCompleted
-
Baylor UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedMild Cognitive Impairment | Poor Quality SleepUnited States
-
Baylor UniversityUniversity of Michigan; National Center for Complementary and Integrative Health...CompletedBreast Cancer | Hot Flashes | Postmenopausal SymptomsUnited States
-
Ekaterina PogrebtsovaCompletedMental Health Wellness 1
-
The University of Tennessee, KnoxvilleBaylor UniversityRecruitingBreast Cancer | Neoplasm Metastasis | Triple Negative Breast Neoplasms | Inflammatory Breast Neoplasms | Inflammatory Breast Cancer Stage IVUnited States
-
Baylor UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedPoor Quality Sleep | Alzheimer's Disease (Incl Subtypes) | Caregiver StressUnited States
-
Oregon Health and Science UniversityUniversity of GeorgiaActive, not recruitingHIV SeropositivityUnited States
-
University of South FloridaNational Cancer Institute (NCI)CompletedCancer | Unspecified Adult Solid Tumor, Protocol Specific | Psychological StressUnited States, Puerto Rico
-
University of ChicagoInnovations for Poverty ActionRecruitingBias, ImplicitColombia