Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127465
Status:
COMPLETED
Last Update Posted:
2008-12-11
First Post:
2005-08-04
Brief Title:
Investigating the Impact of Tailored Reports on Anxiety Amongst Cancer Patients and Their Confidants
Sponsor:
University of Plymouth
Organization:
University of Plymouth
Study Overview
Official Title:
Investigating the Impact of Tailored Reports on Anxiety
Status:
COMPLETED
Status Verified Date:
2005-08
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:
Objective To explore the hypothesis that different methods of selecting and printing information for cancer patients could improve emotional support by affecting interaction with others and so lead to improved psychological wellbeing
Design Randomised trial with 8 groups three factors 2X2X2 Data collected at recruitment and three month follow-up
Participants 400 patients starting radiotherapy and their confidant the person in who they confide
Interventions Printed booklets
1 Half had general CancerBACUP information for that cancer half had personal information from the medical record plus selected general information
2 Half chose information by interacting with the computer half had a larger volume of material in booklets that were produced automatically
3 Half had additional anxiety management advice
Outcomes Patients views use of booklet with others change in reported social support change in anxiety and depression
Design Randomised trial with 8 groups three factors 2X2X2 Data collected at recruitment and three month follow-up
Participants 400 patients starting radiotherapy and their confidant the person in who they confide
Interventions Printed booklets
1 Half had general CancerBACUP information for that cancer half had personal information from the medical record plus selected general information
2 Half chose information by interacting with the computer half had a larger volume of material in booklets that were produced automatically
3 Half had additional anxiety management advice
Outcomes Patients views use of booklet with others change in reported social support change in anxiety and depression
Detailed Description:
Aim
Based on a randomised trial the researchers aimed to model use of leaflets in the home as a function of three factors
1 whether patients chose the information themselves or if it was chosen for them
2 whether it included personal information from their own medical record or not
3 whether it included anxiety management advice or not
The researchers aimed to model patient and confidants anxiety at three months as a function of these three factors and patients use of leaflets in the home
Patient Population Beatson Oncology Centre BOC Patients thought to be eligible were to be identified from outpatient appointment diaries over fifteen months Medical records were to be checked for all those initially identified to ensure that patients have breast gynaecological prostate or bladder or testicular or selected cancers of the head or neck Patients excluded were to be those
receiving palliative treatment
with no knowledge or understanding of their diagnosis very few
with visual or mental handicap
with severe pain or symptoms causing distress
medical or nursing students
taking part in other trials with possibly confounding interventions and
those not giving informed consent
Sample size The researchers aimed to recruit 400 patients This was to give 80 power to find a difference between 40 and 27 who have improved anxiety between eg 200 in personalised group and 200 in general group
Recruitment Eligible patients were to be sent a letter explaining the study and advising them that a researcher will approach them in a visit to the BOC soon after to seek participation in the study Patients were not to be recruited at their bad news consultation but as soon as possible thereafter and at any point in their course of contact and treatment at the Beatson At recruitment the researcher was to further explain the study and seek written consent If the patient consented the researcher was to arrange a time for the intervention and give the patient a questionnaire to take home to complete themselves and a questionnaire for their confidant
Baseline data Patients were to be asked to bring the completed questionnaire with them to the intervention consultation about one week later The questionnaire included the following sections
1 previous computer and information use perceived knowledge significant others in providing emotional support family and living arrangements
2 a Hospital Anxiety and Depression Scale HADS
3 a Miller Coping Style questionnaire
4 Helgesons measures of social support and negative interactions
Completion of this questionnaire should have taken about half an hour at home
Confidants The researchers aimed to recruit 400 confidants one for each patient but estimated that it were more likely to recruit say 60 of 400 Patients were to be asked if they were prepared to pass on the baseline questionnaire to a person selected by them as the person they are most likely to use to seek emotional support This may be a husband wife partner but may also be a daughter son or friend The confidant questionnaire has sections
1 demographics and relationship to patient newspaper read frequency of discussion with patient perceived knowledge
2 HADS
3 Miller coping style
The researchers did not know what proportion of patients would be prepared to pass on the questionnaire or what response rate would be received from confidants Rees in her work with daughters of women with breast cancer found that 93 of patients passed the questionnaires on and 77 of daughters responded If we got an overall 60 response ie 240 before and after questionnaires this would give us 80 power to find a difference between 40 and 23 who had improved anxiety between eg 120 in personalised group vs 120 in general group The confidant population would be less than the patient population Patients will not be excluded if there is no corresponding confidant
Randomisation for the three factors After recruitment the RA was to randomise for each of the three binary factors 2X2X2 factorial design
A Interactive v Automatic
B Medical Record v General
C Anxiety reducing advice v no advice
Patients were to randomised to the eight sub-groups in blocks of 32 and separately by breast vs rest The eight 2X2X2 subgroups each receive different styles of leaflet These are detailed further below
Baseline Data Collected from case notes was to be severity length of onset of cancer treatments so far surgery radiotherapy chemotherapy date of birth gender address deprivation category from postcode for all patients and a problem and treatment list for patients in the medical record groups
Intervention The delay between recruitment and intervention was to allow patients time to think about their participation and withdraw if desired At the intervention patients were to produce a report about their cancer Patients in the automatic group would not need to use the computer
Interactive vs automatic Those in the interactive groups were to choose from menus see information on the screen and press an add to report button on information screens for that information which they want to include in their report Patients choices were to be recorded by the computer
Those in the medical records group were to have personal information included based on their medical record They were to either have information automatically selected and formatted by the computer or to see it on screen and choose what they want to include
Lastly half the patients were to have an additional section offering advice for the reduction of anxiety This section was written based on previous work in cognitive behavioural therapy for anxiety
All reports were to include colour photos for example of treatment rooms staff and diagrams for example anatomical of good quality printing etc The patient were to be given the report to take away
Three month follow-up At three months patients were to be sent a follow-up questionnaire with the following sections
1 questions about their satisfaction with the information received their use of their reports their interactions with their family and friends and the influence of the reports on these interactions their perceived knowledge
2 HADS
3 Helgesons social support questionnaires
Significant others will be sent a questionnaire which has sections on
1 questions about their satisfaction with the information they have received
2 HADS
Measures of Outcome
Change in anxiety for patient or confidant between intervention and 3 month follow-up HADS
Change in social support for patient between intervention and 3 months Helgeson
Patient satisfaction with information score at 3 month follow-up
Confidant satisfaction with information score at 3 month follow-up
Whether patient had read report shown it or discussed it with the named confidant other family members or friends and whether the discussion was aided by use of the report
What patients liked and disliked about the reports
Amongst the interactive group choices made between presentation styles and how well these would correspond to automatic computer choices
Patient and staff time and hence costs needed for routine delivery of each intervention will be modelled on a variety of assumptions
Analysis The researchers were to produce a CONSORT patient flow diagram and compare losses to follow-up by the three interventions ABC Analysis of outcomes was to be for those patients completing both intervention and follow-up The researchers will focus on the following
Comparison of outcomes 1-4 by interventions A B and C while controlling for age gender cancer site time since diagnosis severity coping style using analysis of variance factorial design and multiple logistic regression
Comparison of outcomes 5 and 6 by interventions AB and C qualitative
Modelling of anxiety outcomes 1-2 on use of report at home outcome 4 perceived social support and interventions ABC
Frequencies of choices outcome 7 and comparison with automatic selection both statistically and through qualitative description of the differences
Comparison of patient and NHS costs outcome 8 will be made between the methods used in this trial and other methods of providing information
Comparison of anxiety change in patient and significant other
Analyses will be on those completing follow-up No substitution of data will be carried out for those randomised but not completing follow-up The researchers will thus be able to make provisional conclusions on how the different types of information provision influence interaction anxiety and patient satisfaction and on the correlation between the use of information with family and anxiety The researchers will have information on patient selection to inform the better development of automatic systems and costs to inform practical deployment
Based on a randomised trial the researchers aimed to model use of leaflets in the home as a function of three factors
1 whether patients chose the information themselves or if it was chosen for them
2 whether it included personal information from their own medical record or not
3 whether it included anxiety management advice or not
The researchers aimed to model patient and confidants anxiety at three months as a function of these three factors and patients use of leaflets in the home
Patient Population Beatson Oncology Centre BOC Patients thought to be eligible were to be identified from outpatient appointment diaries over fifteen months Medical records were to be checked for all those initially identified to ensure that patients have breast gynaecological prostate or bladder or testicular or selected cancers of the head or neck Patients excluded were to be those
receiving palliative treatment
with no knowledge or understanding of their diagnosis very few
with visual or mental handicap
with severe pain or symptoms causing distress
medical or nursing students
taking part in other trials with possibly confounding interventions and
those not giving informed consent
Sample size The researchers aimed to recruit 400 patients This was to give 80 power to find a difference between 40 and 27 who have improved anxiety between eg 200 in personalised group and 200 in general group
Recruitment Eligible patients were to be sent a letter explaining the study and advising them that a researcher will approach them in a visit to the BOC soon after to seek participation in the study Patients were not to be recruited at their bad news consultation but as soon as possible thereafter and at any point in their course of contact and treatment at the Beatson At recruitment the researcher was to further explain the study and seek written consent If the patient consented the researcher was to arrange a time for the intervention and give the patient a questionnaire to take home to complete themselves and a questionnaire for their confidant
Baseline data Patients were to be asked to bring the completed questionnaire with them to the intervention consultation about one week later The questionnaire included the following sections
1 previous computer and information use perceived knowledge significant others in providing emotional support family and living arrangements
2 a Hospital Anxiety and Depression Scale HADS
3 a Miller Coping Style questionnaire
4 Helgesons measures of social support and negative interactions
Completion of this questionnaire should have taken about half an hour at home
Confidants The researchers aimed to recruit 400 confidants one for each patient but estimated that it were more likely to recruit say 60 of 400 Patients were to be asked if they were prepared to pass on the baseline questionnaire to a person selected by them as the person they are most likely to use to seek emotional support This may be a husband wife partner but may also be a daughter son or friend The confidant questionnaire has sections
1 demographics and relationship to patient newspaper read frequency of discussion with patient perceived knowledge
2 HADS
3 Miller coping style
The researchers did not know what proportion of patients would be prepared to pass on the questionnaire or what response rate would be received from confidants Rees in her work with daughters of women with breast cancer found that 93 of patients passed the questionnaires on and 77 of daughters responded If we got an overall 60 response ie 240 before and after questionnaires this would give us 80 power to find a difference between 40 and 23 who had improved anxiety between eg 120 in personalised group vs 120 in general group The confidant population would be less than the patient population Patients will not be excluded if there is no corresponding confidant
Randomisation for the three factors After recruitment the RA was to randomise for each of the three binary factors 2X2X2 factorial design
A Interactive v Automatic
B Medical Record v General
C Anxiety reducing advice v no advice
Patients were to randomised to the eight sub-groups in blocks of 32 and separately by breast vs rest The eight 2X2X2 subgroups each receive different styles of leaflet These are detailed further below
Baseline Data Collected from case notes was to be severity length of onset of cancer treatments so far surgery radiotherapy chemotherapy date of birth gender address deprivation category from postcode for all patients and a problem and treatment list for patients in the medical record groups
Intervention The delay between recruitment and intervention was to allow patients time to think about their participation and withdraw if desired At the intervention patients were to produce a report about their cancer Patients in the automatic group would not need to use the computer
Interactive vs automatic Those in the interactive groups were to choose from menus see information on the screen and press an add to report button on information screens for that information which they want to include in their report Patients choices were to be recorded by the computer
Those in the medical records group were to have personal information included based on their medical record They were to either have information automatically selected and formatted by the computer or to see it on screen and choose what they want to include
Lastly half the patients were to have an additional section offering advice for the reduction of anxiety This section was written based on previous work in cognitive behavioural therapy for anxiety
All reports were to include colour photos for example of treatment rooms staff and diagrams for example anatomical of good quality printing etc The patient were to be given the report to take away
Three month follow-up At three months patients were to be sent a follow-up questionnaire with the following sections
1 questions about their satisfaction with the information received their use of their reports their interactions with their family and friends and the influence of the reports on these interactions their perceived knowledge
2 HADS
3 Helgesons social support questionnaires
Significant others will be sent a questionnaire which has sections on
1 questions about their satisfaction with the information they have received
2 HADS
Measures of Outcome
Change in anxiety for patient or confidant between intervention and 3 month follow-up HADS
Change in social support for patient between intervention and 3 months Helgeson
Patient satisfaction with information score at 3 month follow-up
Confidant satisfaction with information score at 3 month follow-up
Whether patient had read report shown it or discussed it with the named confidant other family members or friends and whether the discussion was aided by use of the report
What patients liked and disliked about the reports
Amongst the interactive group choices made between presentation styles and how well these would correspond to automatic computer choices
Patient and staff time and hence costs needed for routine delivery of each intervention will be modelled on a variety of assumptions
Analysis The researchers were to produce a CONSORT patient flow diagram and compare losses to follow-up by the three interventions ABC Analysis of outcomes was to be for those patients completing both intervention and follow-up The researchers will focus on the following
Comparison of outcomes 1-4 by interventions A B and C while controlling for age gender cancer site time since diagnosis severity coping style using analysis of variance factorial design and multiple logistic regression
Comparison of outcomes 5 and 6 by interventions AB and C qualitative
Modelling of anxiety outcomes 1-2 on use of report at home outcome 4 perceived social support and interventions ABC
Frequencies of choices outcome 7 and comparison with automatic selection both statistically and through qualitative description of the differences
Comparison of patient and NHS costs outcome 8 will be made between the methods used in this trial and other methods of providing information
Comparison of anxiety change in patient and significant other
Analyses will be on those completing follow-up No substitution of data will be carried out for those randomised but not completing follow-up The researchers will thus be able to make provisional conclusions on how the different types of information provision influence interaction anxiety and patient satisfaction and on the correlation between the use of information with family and anxiety The researchers will have information on patient selection to inform the better development of automatic systems and costs to inform practical deployment
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