Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02890615
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2016-08-24
Brief Title:
CanDirect Effectiveness of a Telephone-supported Depression Self-care Intervention for Cancer Survivors
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Effectiveness of a Telephone-supported Depression Self-care Intervention for Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CanDirect
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 eg 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
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 eg 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
Detailed Description:
This pragmatic randomized controlled superiority trial aims to assess the effectiveness of a telephone-supported depression SCI in cancer survivors with moderate depressive symptoms when given in addition to usual care in comparison to usual care only Because of the pragmatic nature of this trial members of both groups will continue to receive usual care for their depression which may vary widely depending on local resources and medical practice At each follow-up participants are asked about specific treatment they have received for depression since entering the study antidepressant medication initiation discontinuation change of dose or psychotherapy and their participation in community support groups and related activities investigators will explore whether this care mediates the effects of the intervention The study includes safeguards for participants who become suicidal or severely depressed during the study
Research questions
Among cancer survivors in the post-treatment phase who have moderate to moderately-severe depressive symptoms Patient Health Questionnaire PHQ-9 score 8-19
1 Primary research question What is the effect of a telephone-supported depression self-care intervention SCI plus usual care compared to usual care only control group CTL on the primary outcome - severity of depression symptoms as measured by the Centre for Epidemiologic Studies Depression Scale CES-D 6 months after randomization Hypothesis Participants who receive the SCI will have better 6 month primary outcomes than those randomized to the Control group
2 Secondary questions
1 What are the effects of the SCI on CES-D score at 3 months depression diagnosis at 6 months and mental health related quality of life activation severity of anxiety symptoms at 3 and 6 months and use of health services over 6 months Hypothesis Participants who receive the SCI will have better health outcomes and lower use of health services than those randomized to the Control group
2 Are the effects of the SCI on the primary outcome modified by 5 primary baseline patient characteristics major depression diagnosis antidepressant medication activation recruitment source clinical vs community and level of education or by 9 secondary patient characteristics cancer type ongoing adjuvant cancer treatment yes no years from cancer diagnosis quartiles severity of anxiety as measured by the Hospital Anxiety and Depression Scale - Anxiety subscale HADS-A physical health-related quality of life as measured by the Physical Component Summary PCS of the Short Form Health Survey SF-12 quartiles sex age quartiles family support for self-management quartiles province of residence Quebec Ontario
Hypothesis and support Effect moderators or modifiers represent variables eg patient characteristics measured at baseline that interact with treatment to change outcome for each sub-group These specify for whom treatment is most effective and can improve power in subsequent trials by better selection of study groups for stratification In selecting those potential modifiersmoderators that will be pre-specified for testing investigators followed consensus criteria for assessment of these factors Pinctus proposes 5 criteria for systematic reviews of randomized controlled trials confirming moderator effects 1 was the analysis a priori 2 was selection of factors for analysis clinically plausible and either theory-based or evidence-based 3 were moderators measured prior to randomization 4 adequate quality of measurement 5 explicit test of the interaction between moderator and treatment For meta-analyses exploring moderator effects criteria 1 and 2 are not required
Investigators will analyze 5 possible moderators using sub-group analyses
Major depression They hypothesize that the intervention will be more effective among participants with a diagnosis of major depression measured through the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Disorders - Major Depressive Syndrome in the Mood Disorders Module SCID than those without A meta-analysis of psychosocial interventions in cancer populations found that studies in which patients were pre-selected for higher levels of distress found greater effectiveness of the intervention A meta-analysis of depression self-care interventions also reported greater effectiveness in patients with major depression although only in univariate analysis
Antidepressant medication Investigators hypothesize that the intervention will be more effective among participants with baseline antidepressant medication than those without A meta-analysis found that the combination of psychotherapy and pharmacotherapy is more effective in the treatment of depression than psychotherapy alone
Activation Investigators hypothesize that the intervention will be more effective among participants with higher baseline activation than those with lower levels As there is no accepted cut-point on the Patient Activation Measure PAM scale higher activation will be defined as a PAM score in the highest quartile In a randomized controlled trial of the depression self-care intervention among primary care patients with chronic physical conditions investigators found that coaching was more effective among patients with higher baseline self-efficacy one component of activation
Recruitment source Investigators hypothesize that the intervention will be more effective among participants recruited from community settings than from clinical settings A meta-analysis of depression self-care interventions also reported lower effectiveness in patients studied in clinical settings although only in univariate analysis Participants recruited from community settings in this study eg from community groups and social media will already be selected to be more motivated to participate actively in the intervention
Level of education Investigators hypothesize that the intervention will be more effective among participants with higher education defined as some education beyond high school eg diploma or university compared with those with only high school or less education Investigators are not aware of evidence supporting this hypothesis but the use of paper and pencil and electronic tools will be more familiar to those with a higher level of education
In addition to these 5 hypothesized moderators investigators propose to examine the following 9 secondary potential baseline moderators each with a maximum of 4 categories
cancer type ongoing adjuvant cancer treatment yes no years from cancer diagnosis quartiles severity of anxiety HADS physical health-related quality of life PCS quartiles sex age quartiles family support for self-management quartiles province of residence Quebec Ontario
3 In the Intervention group is greater adherence to the SCI eg use of self-care tools completion of written exercises and mood monitoring goal setting greater number of coaching contacts associated with better primary and secondary outcomes Hypothesis Participants who adhere to the SCI particularly those who actively engage with the Cognitive behavioural therapy CBT-based tools will have greater reductions in depressive symptoms diagnoses and severity of anxiety symptoms and greater increases in activation and quality of life
3 Economic analysis
An economic analysis of the SCI is beyond the scope of this study In the current study investigators collect patient-reported data on use of health services and request additional optional consent for linkage to health care administrative data the Ontario Health Insurance Plan OHIP Claims database and the Discharge Abstract Database DAD They plan to seek additional funding for analyses of these use of services and administrative data for a future study on impact of the SCI on use of services They will only extract use of services data for patients who consent to this optional element and only for a period 12 months before and 12 months after the date of enrolment in the present trial Patients who consent to use of their administrative data are asked to provide their OHIP number to allow researchers to extract the required data
Research questions
Among cancer survivors in the post-treatment phase who have moderate to moderately-severe depressive symptoms Patient Health Questionnaire PHQ-9 score 8-19
1 Primary research question What is the effect of a telephone-supported depression self-care intervention SCI plus usual care compared to usual care only control group CTL on the primary outcome - severity of depression symptoms as measured by the Centre for Epidemiologic Studies Depression Scale CES-D 6 months after randomization Hypothesis Participants who receive the SCI will have better 6 month primary outcomes than those randomized to the Control group
2 Secondary questions
1 What are the effects of the SCI on CES-D score at 3 months depression diagnosis at 6 months and mental health related quality of life activation severity of anxiety symptoms at 3 and 6 months and use of health services over 6 months Hypothesis Participants who receive the SCI will have better health outcomes and lower use of health services than those randomized to the Control group
2 Are the effects of the SCI on the primary outcome modified by 5 primary baseline patient characteristics major depression diagnosis antidepressant medication activation recruitment source clinical vs community and level of education or by 9 secondary patient characteristics cancer type ongoing adjuvant cancer treatment yes no years from cancer diagnosis quartiles severity of anxiety as measured by the Hospital Anxiety and Depression Scale - Anxiety subscale HADS-A physical health-related quality of life as measured by the Physical Component Summary PCS of the Short Form Health Survey SF-12 quartiles sex age quartiles family support for self-management quartiles province of residence Quebec Ontario
Hypothesis and support Effect moderators or modifiers represent variables eg patient characteristics measured at baseline that interact with treatment to change outcome for each sub-group These specify for whom treatment is most effective and can improve power in subsequent trials by better selection of study groups for stratification In selecting those potential modifiersmoderators that will be pre-specified for testing investigators followed consensus criteria for assessment of these factors Pinctus proposes 5 criteria for systematic reviews of randomized controlled trials confirming moderator effects 1 was the analysis a priori 2 was selection of factors for analysis clinically plausible and either theory-based or evidence-based 3 were moderators measured prior to randomization 4 adequate quality of measurement 5 explicit test of the interaction between moderator and treatment For meta-analyses exploring moderator effects criteria 1 and 2 are not required
Investigators will analyze 5 possible moderators using sub-group analyses
Major depression They hypothesize that the intervention will be more effective among participants with a diagnosis of major depression measured through the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Disorders - Major Depressive Syndrome in the Mood Disorders Module SCID than those without A meta-analysis of psychosocial interventions in cancer populations found that studies in which patients were pre-selected for higher levels of distress found greater effectiveness of the intervention A meta-analysis of depression self-care interventions also reported greater effectiveness in patients with major depression although only in univariate analysis
Antidepressant medication Investigators hypothesize that the intervention will be more effective among participants with baseline antidepressant medication than those without A meta-analysis found that the combination of psychotherapy and pharmacotherapy is more effective in the treatment of depression than psychotherapy alone
Activation Investigators hypothesize that the intervention will be more effective among participants with higher baseline activation than those with lower levels As there is no accepted cut-point on the Patient Activation Measure PAM scale higher activation will be defined as a PAM score in the highest quartile In a randomized controlled trial of the depression self-care intervention among primary care patients with chronic physical conditions investigators found that coaching was more effective among patients with higher baseline self-efficacy one component of activation
Recruitment source Investigators hypothesize that the intervention will be more effective among participants recruited from community settings than from clinical settings A meta-analysis of depression self-care interventions also reported lower effectiveness in patients studied in clinical settings although only in univariate analysis Participants recruited from community settings in this study eg from community groups and social media will already be selected to be more motivated to participate actively in the intervention
Level of education Investigators hypothesize that the intervention will be more effective among participants with higher education defined as some education beyond high school eg diploma or university compared with those with only high school or less education Investigators are not aware of evidence supporting this hypothesis but the use of paper and pencil and electronic tools will be more familiar to those with a higher level of education
In addition to these 5 hypothesized moderators investigators propose to examine the following 9 secondary potential baseline moderators each with a maximum of 4 categories
cancer type ongoing adjuvant cancer treatment yes no years from cancer diagnosis quartiles severity of anxiety HADS physical health-related quality of life PCS quartiles sex age quartiles family support for self-management quartiles province of residence Quebec Ontario
3 In the Intervention group is greater adherence to the SCI eg use of self-care tools completion of written exercises and mood monitoring goal setting greater number of coaching contacts associated with better primary and secondary outcomes Hypothesis Participants who adhere to the SCI particularly those who actively engage with the Cognitive behavioural therapy CBT-based tools will have greater reductions in depressive symptoms diagnoses and severity of anxiety symptoms and greater increases in activation and quality of life
3 Economic analysis
An economic analysis of the SCI is beyond the scope of this study In the current study investigators collect patient-reported data on use of health services and request additional optional consent for linkage to health care administrative data the Ontario Health Insurance Plan OHIP Claims database and the Discharge Abstract Database DAD They plan to seek additional funding for analyses of these use of services and administrative data for a future study on impact of the SCI on use of services They will only extract use of services data for patients who consent to this optional element and only for a period 12 months before and 12 months after the date of enrolment in the present trial Patients who consent to use of their administrative data are asked to provide their OHIP number to allow researchers to extract the required data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None