Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106717
Status:
COMPLETED
Last Update Posted:
2008-03-20
First Post:
2005-03-29
Brief Title:
Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life
Sponsor:
Javeriana University
Organization:
Javeriana University
Study Overview
Official Title:
Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life
Status:
COMPLETED
Status Verified Date:
2005-03
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:
None
Brief Summary:
Narrative medicine addresses the therapeutic benefits that derive from patients forming and telling their personal stories It offers an innovative model for improving health outcomes When a patient with cancer and marked suffering writes a narrative of what he or she is going through this process may reduce pain and improve quality of life
Therefore we seek to evaluate the effectiveness of writing a narrative on pain intensity and health related quality of life
We propose a randomized single blind evaluator controlled trial Patients with cancer pain of intensity at least 510 with a minimum Karnofsky score of 50 will be randomized into three groups 1 Narrative group Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks 2 Writing-control group Patients will fill a pain diary once a week for three weeks 3 Control group Subjects will not writefill anything Pain will be evaluated using the numerical scale before randomization and then weekly for 8 weeks We will also evaluate how pain interferes with general activity mood work relation with others sleep and enjoyment of life using the Brief Pain Inventory As secondary outcomes we will evaluate health related quality of life with the treatment outcomes of pain survey which is a modification of the SF 36 short form health survey and a global measure of well-being before randomization and then at 4 and 8 weeks We will also evaluate the emotional disclosure of the narratives
We will use an intention to treat analysis To analyze the effect of the treatment on pain intensity quality of life and well-being we will employ an analysis of repeated measures using generalized estimating equations We will include in the regression models the treatment group the emotional disclosure score the time and the interaction between treatment group and time
Therefore we seek to evaluate the effectiveness of writing a narrative on pain intensity and health related quality of life
We propose a randomized single blind evaluator controlled trial Patients with cancer pain of intensity at least 510 with a minimum Karnofsky score of 50 will be randomized into three groups 1 Narrative group Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks 2 Writing-control group Patients will fill a pain diary once a week for three weeks 3 Control group Subjects will not writefill anything Pain will be evaluated using the numerical scale before randomization and then weekly for 8 weeks We will also evaluate how pain interferes with general activity mood work relation with others sleep and enjoyment of life using the Brief Pain Inventory As secondary outcomes we will evaluate health related quality of life with the treatment outcomes of pain survey which is a modification of the SF 36 short form health survey and a global measure of well-being before randomization and then at 4 and 8 weeks We will also evaluate the emotional disclosure of the narratives
We will use an intention to treat analysis To analyze the effect of the treatment on pain intensity quality of life and well-being we will employ an analysis of repeated measures using generalized estimating equations We will include in the regression models the treatment group the emotional disclosure score the time and the interaction between treatment group and time
Detailed Description:
Background and Significance To our knowledge there are no randomized controlled trials RCTs that evaluate the benefits of narrative medicine but there has been research on the effect of writing about traumatic events on health outcomes which resembles writing a narrative However the populations included have been almost exclusively young healthy students or workers and the majority of studies have been performed by the same research group
Study Population We will recruit patients with cancer who report a pain intensity of at least 510 We will include patients who are still able to read and write To evaluate this physical ability we will use the Karnofsky scale The minimum score a patient needs to have will be 50
Study Design This is a randomized single blind evaluator controlled trial Patients will sign an informed consent Patients will be randomized into three groups
1 Narrative group Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks 2 Writing-control group Patients will fill a pain diary requiring approximately 20 minutes once a week for three weeks 3 Control group Subjects will not writefill out anything
Patients in the narrative group will be asked to write about their illness and how it has affected their lives We will not guide the narrative in any other way
The number of office visits will be the same in the three groups all patients will be seen weekly up to a total of 8 weeks In addition the pain physician will fill a check list to make sure that the presence and severity of symptoms important to patients such as pain nausea anorexia constipation and lack of sleep are addressed in all subjects
We will evaluate the content of the narratives For the evaluation of the narratives we will use a Likert scale that goes from no emotional disclosure to very much emotional disclosure We will also count the number of cognitive words and the number of positive and negative emotion words The quantitative analysis of vocabulary will be performed with a text-analysis computer program
Primary Outcome Reduction of pain intensity is the primary outcome Pain intensity will be evaluated by a registered nurse who is not aware of the group allocation before randomization and then weekly for 8 weeks To evaluate pain we will use the numerical rating scale in which 0 is no pain and 10 is the worst pain imaginable
Secondary Outcomes Health related quality of life and the sense of well-being are secondary outcomes For the evaluation of health related quality of life we will employ the treatment outcomes of pain survey TOPS which is a modification of the SF-36 for patients with pain Patients will fill the questionnaire with the help of a registered nurse who is not aware of the group allocation before randomization and then at 4 weeks and 8 weeks
For the evaluation of global well-being we will use a Likert scale that goes from very bad to excellent Patients will be asked the global measure of well-being weekly
In addition we will evaluate how pain interferes with general activity mood work relation with others sleep and enjoyment of life using the interference factors of the Brief Pain Inventory BPI
Adherence to Treatment We will call all participants once a week to remind them about writing the story the pain dairy or to come to the office visits
Data Analysis We will use an intention to treat analysis
To analyze the effect of the treatment on pain intensity we will employ an analysis of repeated measures using generalized estimating equations GEE
To determine the effect of the exposure on quality of life we will follow the same procedure described above The outcome of interest will be the score of each dimension evaluated in the TOPS As explanatory variables we will include in the regression models the treatment group the time and the interaction between treatment group and time
To analyze the effect of the exposure on pain interference we will employ GEE similar to the procedure we described above The outcome of interest will be the BPI global score which is a sum of the scores of each one of the dimensions evaluated general activity mood work relation with others sleep and enjoyment of life If the BPI global score is different among groups we then proceed to evaluate each dimension separately to determine which one is affected by narrative medicine As explanatory variables we will include in the regression models the treatment group the time and the interaction between treatment group and time
To determine the effect of the exposure on the global measure of well-being we will use a similar approach described for pain intensity and quality of life The outcome variable will be the well-being score and the explanatory variables will be treatment group the time and the interaction between treatment group and time
To determine the impact of the quality of the narrative on each of the outcomes evaluated pain intensity pain interference quality of life and well-being we will include in the corresponding regression model in addition to the explanatory variables treatment group the time the interaction between treatment group and time the emotional disclosure score
Due to the subjectivity of the emotional disclosure evaluation two physicians will perform the evaluation the pain physician and the psychiatrist We will measure the agreement between the two evaluators using the Kappa statistics for ordinal variables
To identify and characterize those patients who best respond to narrative medicine we will include in all the regression models described above the gender education level age of the subject and the interaction between these variables and the treatment group The evaluation of the interactions will permit us to determine if the effect of narrative medicine depends on the gender education level or age of the patients In addition we will use latent growth curve analyses to explore the effect of these variables
To establish the feasibility of narrative intervention we will compare the number of patients who adhere to the treatment in each group using a chi square test
Study Period The exposure will have a duration of 3 weeks and then we will continue the follow up for 5 more weeks for a total of 8 weeks We estimate that in 12 months we can finish the recruitment and follow up of the patients and that we need 3 more months to analyze the data and to prepare the manuscript for publication
Sample Size We have shown that a difference of 2 units in a scale from 0 to 10 is clinically important to patients To detect such difference between the groups with 80 power and an alpha error of 005 assuming that the baseline pain intensity in our patients will be on average 6 4 we estimated the need for 63 patients per group To allow for a 10 loss of follow up we will include a total of 70 patients per group
To assure that patients with advanced cancer will be similarly distributed in the three groups we will use a stratified randomization Our measure of disease severity will be the Karnofsky scale The cutoff will be 80 A score of 80 or higher indicates that the patient is able to work
Study Population We will recruit patients with cancer who report a pain intensity of at least 510 We will include patients who are still able to read and write To evaluate this physical ability we will use the Karnofsky scale The minimum score a patient needs to have will be 50
Study Design This is a randomized single blind evaluator controlled trial Patients will sign an informed consent Patients will be randomized into three groups
1 Narrative group Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks 2 Writing-control group Patients will fill a pain diary requiring approximately 20 minutes once a week for three weeks 3 Control group Subjects will not writefill out anything
Patients in the narrative group will be asked to write about their illness and how it has affected their lives We will not guide the narrative in any other way
The number of office visits will be the same in the three groups all patients will be seen weekly up to a total of 8 weeks In addition the pain physician will fill a check list to make sure that the presence and severity of symptoms important to patients such as pain nausea anorexia constipation and lack of sleep are addressed in all subjects
We will evaluate the content of the narratives For the evaluation of the narratives we will use a Likert scale that goes from no emotional disclosure to very much emotional disclosure We will also count the number of cognitive words and the number of positive and negative emotion words The quantitative analysis of vocabulary will be performed with a text-analysis computer program
Primary Outcome Reduction of pain intensity is the primary outcome Pain intensity will be evaluated by a registered nurse who is not aware of the group allocation before randomization and then weekly for 8 weeks To evaluate pain we will use the numerical rating scale in which 0 is no pain and 10 is the worst pain imaginable
Secondary Outcomes Health related quality of life and the sense of well-being are secondary outcomes For the evaluation of health related quality of life we will employ the treatment outcomes of pain survey TOPS which is a modification of the SF-36 for patients with pain Patients will fill the questionnaire with the help of a registered nurse who is not aware of the group allocation before randomization and then at 4 weeks and 8 weeks
For the evaluation of global well-being we will use a Likert scale that goes from very bad to excellent Patients will be asked the global measure of well-being weekly
In addition we will evaluate how pain interferes with general activity mood work relation with others sleep and enjoyment of life using the interference factors of the Brief Pain Inventory BPI
Adherence to Treatment We will call all participants once a week to remind them about writing the story the pain dairy or to come to the office visits
Data Analysis We will use an intention to treat analysis
To analyze the effect of the treatment on pain intensity we will employ an analysis of repeated measures using generalized estimating equations GEE
To determine the effect of the exposure on quality of life we will follow the same procedure described above The outcome of interest will be the score of each dimension evaluated in the TOPS As explanatory variables we will include in the regression models the treatment group the time and the interaction between treatment group and time
To analyze the effect of the exposure on pain interference we will employ GEE similar to the procedure we described above The outcome of interest will be the BPI global score which is a sum of the scores of each one of the dimensions evaluated general activity mood work relation with others sleep and enjoyment of life If the BPI global score is different among groups we then proceed to evaluate each dimension separately to determine which one is affected by narrative medicine As explanatory variables we will include in the regression models the treatment group the time and the interaction between treatment group and time
To determine the effect of the exposure on the global measure of well-being we will use a similar approach described for pain intensity and quality of life The outcome variable will be the well-being score and the explanatory variables will be treatment group the time and the interaction between treatment group and time
To determine the impact of the quality of the narrative on each of the outcomes evaluated pain intensity pain interference quality of life and well-being we will include in the corresponding regression model in addition to the explanatory variables treatment group the time the interaction between treatment group and time the emotional disclosure score
Due to the subjectivity of the emotional disclosure evaluation two physicians will perform the evaluation the pain physician and the psychiatrist We will measure the agreement between the two evaluators using the Kappa statistics for ordinal variables
To identify and characterize those patients who best respond to narrative medicine we will include in all the regression models described above the gender education level age of the subject and the interaction between these variables and the treatment group The evaluation of the interactions will permit us to determine if the effect of narrative medicine depends on the gender education level or age of the patients In addition we will use latent growth curve analyses to explore the effect of these variables
To establish the feasibility of narrative intervention we will compare the number of patients who adhere to the treatment in each group using a chi square test
Study Period The exposure will have a duration of 3 weeks and then we will continue the follow up for 5 more weeks for a total of 8 weeks We estimate that in 12 months we can finish the recruitment and follow up of the patients and that we need 3 more months to analyze the data and to prepare the manuscript for publication
Sample Size We have shown that a difference of 2 units in a scale from 0 to 10 is clinically important to patients To detect such difference between the groups with 80 power and an alpha error of 005 assuming that the baseline pain intensity in our patients will be on average 6 4 we estimated the need for 63 patients per group To allow for a 10 loss of follow up we will include a total of 70 patients per group
To assure that patients with advanced cancer will be similarly distributed in the three groups we will use a stratified randomization Our measure of disease severity will be the Karnofsky scale The cutoff will be 80 A score of 80 or higher indicates that the patient is able to work
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