Fatigue, Anxiety, Music, and Entertainment (FAME) Study
NCT ID: NCT03955003
Last Updated: 2021-05-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
21 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-05-13
Study Completion Date
2020-12-15
Brief Summary
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Evaluate the feasibility of a six-week group drumming intervention on fatigue, anxiety, and cognitive impairment when compared to an attentional control for cancer patients who have undergone at least one treatment session of chemotherapy or radiation therapy.
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Detailed Description
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The AIMS related to specific outcomes are:
AIM 1. Evaluate the feasibility of a group drumming intervention.
RQ 1.1 What are the rates of recruitment?
RQ 1.2 What are the potential barriers to recruitment?
RQ 1.3 Was the group drumming intervention protocol delivered as designed?
RQ 1.4 Did the attention control group follow designed protocol?
RQ 1.5 What are the differences in treatment acceptability?
AIM 2. Evaluate adherence and duration between a group drumming intervention and attention control group.
RQ 2.1 What are the adherence rates for the 6-week interventions among cancer patients, and were these rates similar in the two treatment arms?
RQ 2.2 What are the dropout rates for the 6-week interventions among cancer patients, and were these rates similar in the two treatment arms?
RQ 2.3 Are there differential reasons for drop out based on group assignment?
AIM 3. To obtain preliminary data describing the impact of group drumming on fatigue and anxiety severity levels and change patterns over time as compared to an attentional control group.
Exploratory AIMs. To explore whether cancer patients, who participate in a 6-week group drumming intervention, will show improvement in cognitive function, as measured by the Functional Assessment of Cancer Therapy-Cognition (FACT-COG). To explore impact on group drumming and positive affect as measured by Positive Affect \& Well-being Scale-Short Form (PAW-SF) and Core Flow States (C FSS).
Statistical Methods, Data Analysis, and Interpretation. Demographics, feasibility measures, and outcome measures will be analyzed through a combination of descriptive and inferential analysis. Sample characteristics will be reported as means and quartiles, counts, or percentages, as appropriate, along with standard deviations or interquartile ranges to describe variability. Where it is possible to construe sample values as population estimates, standard errors and confidence intervals will also be provided. Comparable information will be provided for the samples randomly assigned to receive either intervention or attention control. Any chance imbalance will be controlled statistically by conditioning on baseline values, as described in many of the statistical references. Drop out and attendance percentages will be calculated within each group and evaluated as potential treatment responses.
Aim 1: This AIM focuses on determining the pragmatic possibility of success in recruiting and delivering a group drumming intervention. Rates of recruitment will include reporting the percentage of people who expressed an interest in participating from those approached, percentage of people who met inclusion criteria from those who expressed an interest, percentage of people consented from those who met inclusion criteria, the percentage of people consented from those who met inclusion criteria, the percentage of people who completed the questionnaires. Barriers to recruitment will include reporting percentage of those who were excluded from those who expressed an interest, documentation of barriers people stated for not being able to participate in the study with percentages for each reason. A CONSORT flowchart will be used to show how many people were screened, how many were eligible or excluded, how many consented, and how many completed the study. Fidelity related to following protocols for the group drumming intervention will be evaluated by using a music therapy validity checklist. The music therapist facilitating the intervention will sign a copy of the protocol and fidelity checklist prior to beginning the intervention and the percentage of deviations will be recorded on the protocol fidelity check list by the principal investigator during the first intervention group to be sure that the protocol is being followed in order to ensure fidelity.
Aim 2: Adherence (compliance, persistence, "dose") between a group drumming intervention and attention control group will be calculated based upon percentages of participants who missed a group, percentage of participants who dropped out, percentage of people who did not complete the study, and percentage of people who completed the study. Confidence intervals for the percentages will be derived from exact permutational tests that require no distributional assumptions and are hence more appropriate for small samples than those based on normal theory. Duration will be examined using discrete time survival analysis and bootstrapped confidence intervals. Reasons for missing a group will be tallied (see appendix 9), and grouped into "unrelated" or "possibly treatment-related" categories. Examples of "presumptively unrelated" reasons would be colds or minor illness, dental or medical appointments, family issues, or moved to a different area. If participants missed a group session because they could not accept or tolerate the experience, this would be coded as possibly treatment-related. Those who actively withdraw (letting music therapist or research team member know ahead of group or after group that they don't plan to return) will be noted separately as neutral reasons from those who passively withdraw (don't show up).
Similarly, the percentage of positive and negative answers to "How did the session go today?" will be reported. The answers to the two questions "what made this study challenging for you to attend?" and "what didn't you like about it?" will be reported and categorized into percentages.
Exploratory Aim 3: This aim provides preliminary pilot data describing the impact of group drumming on fatigue, anxiety, and cognitive impairment severity levels and change patterns. These data will be needed to plan sample size and design features in a future definitive comparative study. For this purpose, a formal statistical model is most useful, since it generates parameter estimates that can be applied to power calculations for similar model-based analyses to be used in the future study. Two aspects of an individual's response are relevant: the degree of overall treatment impact (gain) and the mean rate-of-change post-baseline (trend). Fatigue will be analyzed by looking at gain and trend of individual FACIT-F scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. Anxiety will be analyzed by looking at gain and trend of individual using STAI scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. Cognitive impairment will be analyzed by looking at gain and trend of individual using FACT-COG scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
Analysis model. The two primary outcomes of fatigue and anxiety will be analyzed using a mixed effects linear model that assumes that individual longitudinal responses, conditional on baseline values, are generated by treatment assignment, and time since baseline. Specifically, the post-baseline measures at three, six, and eight weeks after the last group ends will be analyzed by examining the difference in mean adjusted gains and trends. Equally important in this kind of pilot study, the model yields empirical Bayes estimates of individual gains and time trends. Such a clinical impact analysis model will allow the study to show individual responses related to who is benefitting, how much they are benefitting so that responses can be viewed based on trend and adjusted gain (or loss), and how varied these responses are relative to the mean treatment impact. Details of the model are developed in multiple scientific publications.
The following hypotheses will be explored under the clinical impact model: HImpact: Drumming yields greater mean improvement on fatigue, anxiety and cognitive impairment than does attention control. Hpersistence: The mean rate-of-change with drumming is more positive than that of the control treatment, Hheterogeneity: Patients receiving either intervention vary in the extent of their benefit. Data will be analyzed using SPSS Mixed and SAS Proc Mixed programs under inferential options appropriate for smaller samples (Restricted Maximum Likelihood with Kenward-Roger Degrees of Freedom). The hypothesis represents plausible expectations, not formal statistical assumptions of population magnitudes. The purpose of the analyses is to generate estimates for future planning, not to reach definitive conclusions.
I plan to recruit 26 participants (n=13 treatment, n=13 control) allowing for 20% drop out to yield 10 per group will allow me to plot the distributions of the individual and mean estimates in a scatterplot with adjusted gain and trend as the two axes.
AIM 1. Evaluate the feasibility of a group drumming intervention.
RQ 1.1 What are the rates of recruitment?
RQ 1.2 What are the potential barriers to recruitment?
RQ 1.3 Was the group drumming intervention protocol delivered as designed?
RQ 1.4 Did the attention control group follow designed protocol?
RQ 1.5 What are the differences in treatment acceptability?
AIM 2. Evaluate adherence and duration between a group drumming intervention and attention control group.
RQ 2.1 What are the adherence rates for the 6-week interventions among cancer patients, and were these rates similar in the two treatment arms?
RQ 2.2 What are the dropout rates for the 6-week interventions among cancer patients, and were these rates similar in the two treatment arms?
RQ 2.3 Are there differential reasons for drop out based on group assignment?
AIM 3. To obtain preliminary data describing the impact of group drumming on fatigue and anxiety severity levels and change patterns over time as compared to an attentional control group.
Exploratory AIMs. To explore whether cancer patients, who participate in a 6-week group drumming intervention, will show improvement in cognitive function, as measured by the Functional Assessment of Cancer Therapy-Cognition (FACT-COG). To explore impact on group drumming and positive affect as measured by Positive Affect \& Well-being Scale-Short Form (PAW-SF) and Core Flow States (C FSS).
Statistical Methods, Data Analysis, and Interpretation. Demographics, feasibility measures, and outcome measures will be analyzed through a combination of descriptive and inferential analysis. Sample characteristics will be reported as means and quartiles, counts, or percentages, as appropriate, along with standard deviations or interquartile ranges to describe variability. Where it is possible to construe sample values as population estimates, standard errors and confidence intervals will also be provided. Comparable information will be provided for the samples randomly assigned to receive either intervention or attention control. Any chance imbalance will be controlled statistically by conditioning on baseline values, as described in many of the statistical references. Drop out and attendance percentages will be calculated within each group and evaluated as potential treatment responses.
Aim 1: This AIM focuses on determining the pragmatic possibility of success in recruiting and delivering a group drumming intervention. Rates of recruitment will include reporting the percentage of people who expressed an interest in participating from those approached, percentage of people who met inclusion criteria from those who expressed an interest, percentage of people consented from those who met inclusion criteria, the percentage of people consented from those who met inclusion criteria, the percentage of people who completed the questionnaires. Barriers to recruitment will include reporting percentage of those who were excluded from those who expressed an interest, documentation of barriers people stated for not being able to participate in the study with percentages for each reason. A CONSORT flowchart will be used to show how many people were screened, how many were eligible or excluded, how many consented, and how many completed the study. Fidelity related to following protocols for the group drumming intervention will be evaluated by using a music therapy validity checklist. The music therapist facilitating the intervention will sign a copy of the protocol and fidelity checklist prior to beginning the intervention and the percentage of deviations will be recorded on the protocol fidelity check list by the principal investigator during the first intervention group to be sure that the protocol is being followed in order to ensure fidelity.
Aim 2: Adherence (compliance, persistence, "dose") between a group drumming intervention and attention control group will be calculated based upon percentages of participants who missed a group, percentage of participants who dropped out, percentage of people who did not complete the study, and percentage of people who completed the study. Confidence intervals for the percentages will be derived from exact permutational tests that require no distributional assumptions and are hence more appropriate for small samples than those based on normal theory. Duration will be examined using discrete time survival analysis and bootstrapped confidence intervals. Reasons for missing a group will be tallied (see appendix 9), and grouped into "unrelated" or "possibly treatment-related" categories. Examples of "presumptively unrelated" reasons would be colds or minor illness, dental or medical appointments, family issues, or moved to a different area. If participants missed a group session because they could not accept or tolerate the experience, this would be coded as possibly treatment-related. Those who actively withdraw (letting music therapist or research team member know ahead of group or after group that they don't plan to return) will be noted separately as neutral reasons from those who passively withdraw (don't show up).
Similarly, the percentage of positive and negative answers to "How did the session go today?" will be reported. The answers to the two questions "what made this study challenging for you to attend?" and "what didn't you like about it?" will be reported and categorized into percentages.
Exploratory Aim 3: This aim provides preliminary pilot data describing the impact of group drumming on fatigue, anxiety, and cognitive impairment severity levels and change patterns. These data will be needed to plan sample size and design features in a future definitive comparative study. For this purpose, a formal statistical model is most useful, since it generates parameter estimates that can be applied to power calculations for similar model-based analyses to be used in the future study. Two aspects of an individual's response are relevant: the degree of overall treatment impact (gain) and the mean rate-of-change post-baseline (trend). Fatigue will be analyzed by looking at gain and trend of individual FACIT-F scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. Anxiety will be analyzed by looking at gain and trend of individual using STAI scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. Cognitive impairment will be analyzed by looking at gain and trend of individual using FACT-COG scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
Analysis model. The two primary outcomes of fatigue and anxiety will be analyzed using a mixed effects linear model that assumes that individual longitudinal responses, conditional on baseline values, are generated by treatment assignment, and time since baseline. Specifically, the post-baseline measures at three, six, and eight weeks after the last group ends will be analyzed by examining the difference in mean adjusted gains and trends. Equally important in this kind of pilot study, the model yields empirical Bayes estimates of individual gains and time trends. Such a clinical impact analysis model will allow the study to show individual responses related to who is benefitting, how much they are benefitting so that responses can be viewed based on trend and adjusted gain (or loss), and how varied these responses are relative to the mean treatment impact. Details of the model are developed in multiple scientific publications.
The following hypotheses will be explored under the clinical impact model: HImpact: Drumming yields greater mean improvement on fatigue, anxiety and cognitive impairment than does attention control. Hpersistence: The mean rate-of-change with drumming is more positive than that of the control treatment, Hheterogeneity: Patients receiving either intervention vary in the extent of their benefit. Data will be analyzed using SPSS Mixed and SAS Proc Mixed programs under inferential options appropriate for smaller samples (Restricted Maximum Likelihood with Kenward-Roger Degrees of Freedom). The hypothesis represents plausible expectations, not formal statistical assumptions of population magnitudes. The purpose of the analyses is to generate estimates for future planning, not to reach definitive conclusions.
I plan to recruit 26 participants (n=13 treatment, n=13 control) allowing for 20% drop out to yield 10 per group will allow me to plot the distributions of the individual and mean estimates in a scatterplot with adjusted gain and trend as the two axes.
Conditions
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Fatigue
Anxiety
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Utilizing a randomized group pilot research design, the feasibility and exploratory impact of a group drumming intervention on fatigue, anxiety, and cognitive impairment in cancer patients will be compared to an attention control. Participants will be randomized to a six-week group drumming intervention or a six-week attention control group. The attention group is intended to control for time effects and the nonspecific effects of participating in a group learning activity.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Participants
Study Groups
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Group Drumming
6 week one hour/week drumming sessions. The detailed intervention protocol was created in collaboration with board-certified music therapists. The music used in the intervention will include both recorded percussion music and the use of percussion instruments.
Group Type
EXPERIMENTAL
Group Drumming
Intervention Type
BEHAVIORAL
Cancer patients will be led by a Board Certified Music Therapist to participate in group drumming for one hour per week, for six weeks.
Attention Control Entertaining Educational Series
6 week one hour/week educational series. The educational group is largely intended to create an attention group control so group effect and time of the drumming intervention can be controlled.
Group Type
OTHER
Attention Control
Intervention Type
OTHER
This is intended to control for time, place, and group affect.
Interventions
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Group Drumming
Cancer patients will be led by a Board Certified Music Therapist to participate in group drumming for one hour per week, for six weeks.
Intervention Type
BEHAVIORAL
Attention Control
This is intended to control for time, place, and group affect.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Adults 18 and over who have received at least one session of chemotherapy or radiation treatment and self-report symptoms of fatigue or anxiety at a level 4 or above on a scale of 0-10.
* Active treatment through one-year post completion of active treatment.
* At least one week after surgery.
* Ability to read and write in English.
* Active treatment through one-year post completion of active treatment.
* At least one week after surgery.
* Ability to read and write in English.
Exclusion Criteria
* Total deafness or severely impaired hearing.
* Absence of arms and/or hands.
* Current engagement in group drumming.
* Scheduled for surgery in the next 12 weeks.
* Currently taking medications for diagnosis of dementia or Alzheimer's disease.
* Substantial, uncorrected vision loss.
* Absence of arms and/or hands.
* Current engagement in group drumming.
* Scheduled for surgery in the next 12 weeks.
* Currently taking medications for diagnosis of dementia or Alzheimer's disease.
* Substantial, uncorrected vision loss.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Shelley White
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Site Status
Countries
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United States
References
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Fairclough, D.L., Design and analysis of quality of life studies in clinical trials. 2010: CRC press.
Reference Type
BACKGROUND
Moinpour CM, Darke AK, Donaldson GW, Thompson IM Jr, Langley C, Ankerst DP, Patrick DL, Ware JE Jr, Ganz PA, Shumaker SA, Lippman SM, Coltman CA Jr. Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2007 Jul 4;99(13):1025-35. doi: 10.1093/jnci/djm023. Epub 2007 Jun 27.
Reference Type
RESULT
Donaldson GW, Moinpour CM. Individual differences in quality-of-life treatment response. Med Care. 2002 Jun;40(6 Suppl):III39-53. doi: 10.1097/00005650-200206001-00007.
Reference Type
RESULT
Moinpour CM, Lovato LC, Thompson IM Jr, Ware JE Jr, Ganz PA, Patrick DL, Shumaker SA, Donaldson GW, Ryan A, Coltman CA Jr. Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors. J Clin Oncol. 2000 May;18(9):1942-53. doi: 10.1200/JCO.2000.18.9.1942.
Reference Type
RESULT
Donaldson GW, Moinpour CM. Learning to live with missing quality-of-life data in advanced-stage disease trials. J Clin Oncol. 2005 Oct 20;23(30):7380-4. doi: 10.1200/JCO.2005.07.022. Epub 2005 Sep 26. No abstract available.
Reference Type
RESULT
Moinpour CM, Donaldson GW, Redman MW. Do general dimensions of quality of life add clinical value to symptom data? J Natl Cancer Inst Monogr. 2007;(37):31-8. doi: 10.1093/jncimonographs/lgm007.
Reference Type
RESULT
Moinpour CM, Donaldson GW, Liepa AM, Melemed AS, O'Shaughnessy J, Albain KS. Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer. Qual Life Res. 2012 Jun;21(5):765-75. doi: 10.1007/s11136-011-9999-z. Epub 2011 Sep 16.
Reference Type
RESULT
Moinpour CM, Darke AK, Donaldson GW, Cespedes D, Johnson CR, Ganz PA, Patrick DL, Ware JE Jr, Shumaker SA, Meyskens FL, Thompson IM Jr. Health-related quality-of-life findings for the prostate cancer prevention trial. J Natl Cancer Inst. 2012 Sep 19;104(18):1373-85. doi: 10.1093/jnci/djs359. Epub 2012 Sep 12.
Reference Type
RESULT
Donaldson GW, Nakamura Y, Moinpour C. Mediators, moderators, and modulators of causal effects in clinical trials--Dynamically Modified Outcomes (DYNAMO) in health-related quality of life. Qual Life Res. 2009 Mar;18(2):137-45. doi: 10.1007/s11136-008-9439-x. Epub 2009 Jan 20.
Reference Type
RESULT
Moinpour CM, Sawyers Triplett J, McKnight B, Lovato LC, Upchurch C, Leichman CG, Muggia FM, Tanaka L, James WA, Lennard M, Meyskens FL Jr. Challenges posed by non-random missing quality of life data in an advanced-stage colorectal cancer clinical trial. Psychooncology. 2000 Jul-Aug;9(4):340-54. doi: 10.1002/1099-1611(200007/08)9:43.0.co;2-f.
Reference Type
RESULT
Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
Reference Type
RESULT
Coffman CJ, Edelman D, Woolson RF. To condition or not condition? Analysing 'change' in longitudinal randomised controlled trials. BMJ Open. 2016 Dec 30;6(12):e013096. doi: 10.1136/bmjopen-2016-013096.
Reference Type
RESULT
Liu GF, Lu K, Mogg R, Mallick M, Mehrotra DV. Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Stat Med. 2009 Sep 10;28(20):2509-30. doi: 10.1002/sim.3639.
Reference Type
RESULT
Liang, K.-Y. and S.L. Zeger, Longitudinal data analysis of continuous and discrete responses for pre-post designs. Sankhyā: The Indian Journal of Statistics, Series B, 2000: p. 134-148.
Reference Type
RESULT
Singer, J.D., J.B. Willett, and J.B. Willett, Applied longitudinal data analysis: Modeling change and event occurrence. 2003: Oxford university press.
Reference Type
RESULT
Other Identifiers
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IRB_00116181
Identifier Type: -
Identifier Source: org_study_id
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