Fatigue, Anxiety, Music, and Entertainment (FAME) Study

NCT03955003 | Completed DMC

• 1 other identifier: IRB_00116181
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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.

  FACIT-F scores can range between 0 and 52 (0 is the worst possible score). The FACIT-F is a 13-item symptom subscale measuring fatigue with chronic illness that has been validated among various cancer diagnosis and has been used in interventional, repeat measure studies with a test-retest reliability of r=0.90 and internal consistency of a=0.95 (Minton \& Stone, 2008).

  Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.

• 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

  The mean rate-of-change for the group post-baseline (trend) will be analyzed. Fatigue will also be analyzed by looking at trend of individual FACIT-F scores that can range between 0 and 52. The FACIT-F is a 13-item symptom subscale measuring fatigue with chronic illness that has been validated among various cancer diagnosis and has been used in interventional, repeat measure studies with a test-retest reliability of r=0.90 and internal consistency of a=0.95 (Minton \& Stone, 2008).

  Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.

• Anxiety severity levels of change over time will be compared to an attentional control group using the STAI-Y form.

  Anxiety will be analyzed by looking at gain of individual State section of State Trait Anxiety Inventory-State Scale (STAI) scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. The STAI-form Y-1 will be used to measure state anxiety. It has been used with cancer patients to measure state anxiety with a Cronbach's alpha score of .94 for state anxiety. STAI-form Y-1-inventory consists of 20 anxiety questions like "I feel calm" with participants rating their answers on a four-point Likert scale (1=not at all, 4=very much so). STAI-Y has a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.

• Anxiety change patterns over time will be compared to an attentional control group using the STAI-Y form.

  Anxiety will be analyzed by looking at the trend of individual using State section of State Trait Anxiety Inventory-State Scale (STAI) scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. The STAI-form Y-1 will be used to measure state anxiety. It has been used with cancer patients to measure state anxiety with a Cronbach's alpha score of .94 for state anxiety. STAI-form Y-1-inventory consists of 20 anxiety questions like "I feel calm" with participants rating their answers on a four-point Likert scale (1=not at all, 4=very much so). STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.

Secondary Outcomes (1)

• 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).

  Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.

Other Outcomes (2)

• Positive affect of group drumming will be measured over time using the Positive Affect & Well-being Scale-Short Form (PAW-SF).

  1st week, 3 weeks, and 6 weeks.

• Having a sense of flow during group drumming will be measured by the Core Flow States Scale (C FSS).

  After each group drumming session (6 weeks).

Study Arms (2)

Group Drumming

EXPERIMENTAL

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.

Behavioral: Group Drumming

Attention Control Entertaining Educational Series

OTHER

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.

Other: Attention Control

Interventions

Group Drumming 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.

Group Drumming

Attention Control OTHER

This is intended to control for time, place, and group affect.

Attention Control Entertaining Educational Series

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84102, United States

Location

Related Publications (15)

• Fairclough, D.L., Design and analysis of quality of life studies in clinical trials. 2010: CRC press.

  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.

  PMID: 17596576 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.

  PMID: 12064757 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.

  PMID: 10784636 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.

  PMID: 16186589 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.

  PMID: 17951229 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.

  PMID: 21922153 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.

  PMID: 22972968 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.

  PMID: 19152118 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.

  PMID: 10960931 RESULT

• Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.

  PMID: 19565683 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.

  PMID: 28039292 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.

  PMID: 19610129 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.

  RESULT

• Singer, J.D., J.B. Willett, and J.B. Willett, Applied longitudinal data analysis: Modeling change and event occurrence. 2003: Oxford university press.

  RESULT

MeSH Terms

Conditions

Fatigue; Anxiety Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 17, 2019
• Study Start: May 13, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)