Clinical trial · Interventional
Fatigue, Anxiety, Music, and Entertainment (FAME) Study
Addressing Fatigue, Anxiety, and Cognitive Impairment Through Rhythmic Effects: A Pilot Feasibility Study Using a Group Drumming Intervention With Cancer Patients
NCT03955003CI-TRIAL-00051629FAMEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control | Other | — | UNRESOLVED |
| Group Drumming | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group Drumming
- description
- 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.
- interventionNames
- Behavioral: Group Drumming
- type
- OTHER
- label
- Attention Control Entertaining Educational Series
- description
- 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.
- interventionNames
- Other: Attention Control
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (15)
- BACKGROUNDFairclough, D.L., Design and analysis of quality of life studies in clinical trials. 2010: CRC press.
- RESULTMoinpour 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
- RESULTDonaldson 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
- RESULTMoinpour 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
- RESULTDonaldson 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
- RESULTMoinpour 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
- RESULTMoinpour 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.