Clinical trial NCT03955003: Fatigue, Anxiety, Music, and Entertainment (FAME) Study
Official title: Addressing Fatigue, Anxiety, and Cognitive Impairment Through Rhythmic Effects: A Pilot Feasibility Study Using a Group Drumming Intervention With Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Anxiety
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Fatigue will be analyzed by looking at the degree of overall treatment impact (gain) changes over time in group and individual Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores.
timeFrame: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
measure: The mean rate-of-change patterns (trend) of group drumming on fatigue over time as compared to an attention control group will be measured using FACIT-F
timeFrame: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
measure: Anxiety severity levels of change over time will be compared to an attentional control group using the STAI-Y form.
timeFrame: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
measure: Anxiety change patterns over time will be compared to an attentional control group using the STAI-Y form.
timeFrame: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
Secondary outcomes:
measure: Cognitive function of 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).
timeFrame: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
Other outcomes:
measure: Positive affect of group drumming will be measured over time using the Positive Affect & Well-being Scale-Short Form (PAW-SF).
timeFrame: 1st week, 3 weeks, and 6 weeks.
measure: Having a sense of flow during group drumming will be measured by the Core Flow States Scale (C FSS).
timeFrame: After each group drumming session (6 weeks).
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
Study officials:
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