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Trial record 95 of 2664 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

CanDirect: Effectiveness of a Telephone-supported Depression Self-care Intervention for Cancer Survivors (CanDirect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02890615
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jane McCusker, MD DrPH, McGill University

Brief Summary:

Depressive symptoms are common in cancer survivors; 15% or more of cancer patients, even 1 year after diagnosis, experience depressive symptoms that can have a negative impact on their quality of life. Canadian care guidelines for cancer survivors recommend supporting the active engagement of survivors in their self-care.

This study is an evaluation of the effect of a depression self-care program which includes a self-care toolkit and support in the form of regular telephone calls from a self-care coach.

The toolkit contains tools that help cancer survivors:

  1. Learn new information to better understand depression. This can help people feel that they are not alone, and that their experience is not abnormal. Better understanding a condition also helps people feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends.
  2. Learn and practice new coping skills. This can help people feel confident that they can engage in the behaviours that have been shown to be beneficial for mood, e.g. restructuring thoughts, problem solving, and planning pleasant activities.

People eligible for the study are aged 18 and over, 1-10 years post-diagnosis, have completed primary cancer treatment (chemotherapy, radiation therapy or surgery) for any type of cancer, and have moderate depressive symptoms (as measured by a Patient Health Questionnaire (PHQ-9) score of 8-19). Recruitment will be conducted at cancer care centres in Montreal and at the Princess Margaret Cancer Centre in Toronto, and via community cancer support groups in Quebec and Ontario. Each participant enrolled in the study will receive the self-care toolkit (half will receive the toolkit and support calls at the start of the study, and half will receive the toolkit at the end), and will be followed for 6 months.

This proposed self-care program is innovative in its approach to the treatment of depression and has the potential to significantly improve the quality of life for Canadian cancer survivors with persistent depressive symptoms. The results of the study will determine whether the supported depression self-care program for cancer survivors is effective. The program is designed to be sustainable and widely applicable as it involves minimal costs, and the coaching can be delivered by telephone by volunteers in hospital and community settings. Investigators will work with clinical stakeholders and patient representatives to ensure that deliverables are relevant to the target population. Specific deliverables (in both French and English) include: a toolkit with a manual describing its use; a manual detailing coaching procedures; reports for decision makers and community cancer care groups; and short summaries for stakeholder groups.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Depression self-care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Telephone-supported Depression Self-care Intervention for Cancer Survivors
Study Start Date : July 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depression Self-care Intervention (SCI)

Intervention group participants will receive the Depression Self-Care Toolkit for Cancer Survivors and will be supported by telephone by a coach who will help to activate them, guide them through the materials, help in selecting appropriate tools, and provide positive reinforcement. Coach contacts will be made every week for 3 months followed by 3 monthly contacts, up to a maximum of 15 contacts, lasting 10-20 minutes each.

The coach uses a stepped approach (i.e. educate about depression, initiate mood monitoring, determine participant's goals with respect to reducing depressive symptoms, and help with the use of specific tools). A suggested script is provided for the coach as a framework for each call. Tailoring of the SCI to different participants will be based on problems, depressive symptoms (from the PHQ-9), or concerns a participant may raise during the call.

Behavioral: Depression self-care
Toolkit and coaching

No Intervention: Control group
Members of both groups will continue to receive "usual care" for their depression. We will not interfere with usual care beyond recommending that participants discuss their depressive symptoms with their doctor. If participants consent, a short progress report will be send to their treating physician at the end of the study. At each follow-up, we will ask participants about specific treatment they have received for depression since entering the study (antidepressant medication initiation, discontinuation, change of dose, or psychotherapy) and use of community resources. The Intervention group will receive the Depression SCI. The Control group will receive only usual care for 6 months after randomization; they will be given the Toolkit with a single coaching call upon completion of the final interview, to ensure their access to depression treatment.



Primary Outcome Measures :
  1. Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, 3 months, 6 months ]

Secondary Outcome Measures :
  1. Change in severity of anxiety symptoms: Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-Anxiety) [ Time Frame: Baseline, 3 months, 6 months ]
  2. Change in mental and physical health-related quality of life: Short Form health survey (SF-12) [ Time Frame: Baseline, 3 months, 6 months ]
  3. Change in activation: Patient Activation Measure (PAM) [ Time Frame: Baseline, 3 months, 6 months ]
  4. Change in depression diagnosis: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV Disorders (SCID) [ Time Frame: Baseline, 6 months ]
  5. Change in use of health services: self-report [ Time Frame: Baseline, 3 month, 6 month ]
    doctor office and clinic visits, emergency room visits, hospitalizations, psychosocial treatment or support group participation, changes in cancer diagnosis or treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • completed primary cancer treatment (surgery, radiation and/or chemotherapy) for any type of cancer (NB: patients receiving adjuvant therapies will be eligible),
  • between 1-10 years post-diagnosis (as suggested by clinicians collaborating on the project),
  • with moderate depressive symptoms (PHQ-9 score of 8-19).

Exclusion criteria:

  • metastatic disease,
  • suicidal,
  • moderate-severe cognitive impairment,
  • unable to speak and read in English or French,
  • only non-melanoma skin cancer (without any other single primary cancer),
  • receiving ongoing psychological treatment at baseline (because of recent finding that this treatment may negatively modify the effectiveness of the coaching component of the intervention). NB: those who begin psychological treatment during follow-up will not be withdrawn.
  • dose of antidepressant medication changed within last 6 weeks at baseline. NB: those who change dose or treatment during follow-up will not be withdrawn.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890615


Locations
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Canada, Quebec
St Mary's Research Centre
Montreal, Quebec, Canada, H3T1M5
Sponsors and Collaborators
McGill University

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Responsible Party: Jane McCusker, MD DrPH, Professor Emerita and Full Professor Post-Retirement, McGill University
ClinicalTrials.gov Identifier: NCT02890615     History of Changes
Other Study ID Numbers: SMHC 16-15
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Keywords provided by Jane McCusker, MD DrPH, McGill University:
Survivors
Self Care

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders