Music-Based Relaxation for Anxiety in Young Cancer Survivors

Overseen By Robert Knoerl

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Hearing impairment, Cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a music-based relaxation program called TiMBRe, designed to reduce anxiety in young cancer survivors. The program lasts eight weeks and includes virtual music sessions tailored to each participant. Half of the participants will try TiMBRe, while the other half will receive standard care, such as calls and resources. It suits individuals aged 15-39 who completed cancer treatment at least a month ago and have recently experienced anxiety. As an unphased trial, this study provides a unique opportunity to explore innovative anxiety-reduction methods tailored to participants' needs.

Do I need to stop my current medications for this trial?

You can continue your current anxiety medications if you started them at least eight weeks before joining the study and haven't changed the dose. If you're planning to start new treatments for anxiety, you can't join the trial.

What prior data suggests that this music-based relaxation intervention is safe for young cancer survivors?

Research has shown that music-based relaxation methods, such as the TiMBRe program, are generally safe. Studies have found that similar music therapy during chemotherapy can reduce anxiety and improve well-being without causing harm. Because music-based treatments don't involve drugs, they avoid medication-related side effects. Participants in past studies reported feeling more relaxed and less anxious after these sessions. While TiMBRe is still under evaluation, it is designed to be well-tolerated, focusing on relaxation and stress relief through gentle, non-invasive music. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for anxiety in young cancer survivors that might include medications or therapy, TiMBRe offers a unique approach through music-based relaxation. This eight-week program is delivered virtually, making it highly accessible regardless of location. Researchers are excited about TiMBRe because it is tailored to individual needs, potentially enhancing its effectiveness in reducing anxiety. Additionally, its non-invasive nature and the comfort of engaging with music could make it a more appealing option for young people.

What evidence suggests that the TiMBRe intervention might be an effective treatment for anxiety?

Research has shown that music-based relaxation techniques can reduce anxiety in young cancer survivors. In this trial, the TiMBRe treatment, which participants may receive, uses music specifically designed to help them relax and feel less anxious. Although limited data exists on TiMBRe's effectiveness, music therapy has shown promise in similar situations for reducing anxiety. This method focuses on calming elements like tone and rhythm. The aim is to provide a soothing experience that may ease the anxiety often felt by young cancer survivors. ^{1 2 5 6 7}

Who Is on the Research Team?

Robert Knoerl

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for young cancer survivors aged 15-39 who have finished cancer treatment at least a month ago and are experiencing significant anxiety. Participants must be able to speak and read English, and they should score ≥55 on the PROMIS Anxiety 4a scale indicating notable anxiety levels.

Inclusion Criteria

Report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)

Speak/read English

I am between 15 and 39 years old.

Exclusion Criteria

Prognosis less than 3 months

I plan to start treatments for anxiety during the study.

I plan to start new medication for anxiety during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an eight-week, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety

8 weeks

8 virtual sessions (45 min/week)

Follow-up

Participants are monitored for changes in anxiety and other outcomes after the intervention

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• TiMBRe

Trial Overview The study is testing an eight-week virtual program called TiMBRe, which involves tailored music-based relaxation sessions lasting 45 minutes each week, aimed at reducing anxiety in adolescent and young adult cancer survivors.

How Is the Trial Designed?

Group I: TiMBRe Experimental Treatment 1 Intervention

an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in AYA cancer survivors with clinically-relevant anxiety.

Group II: Attention-Control Active Control 1 Intervention

Standard of care study staff calls and cancer survivorship resources

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 111 cancer in-patients showed that attending live music concerts significantly reduced their state anxiety by an average of 3.87 points, indicating a positive psychological impact.

The results suggest that organizing live music events in oncology units can be an effective way to improve the mental well-being of patients during their hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Live concerts reduce cancer inpatients' anxiety. Toccafondi, A., Bonacchi, A., Mambrini, A., et al.[2018]

In a study involving 42 men undergoing radiation therapy, music therapy did not significantly reduce anxiety levels compared to standard care, indicating that it may not be an effective intervention for all patients.

However, post-hoc analyses suggested that music therapy could still provide some benefits for patients with high anxiety levels, highlighting the need for tailored nursing interventions based on individual anxiety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music as a therapeutic intervention for anxiety in patients receiving radiation therapy. Smith, M., Casey, L., Johnson, D., et al.[2006]

In a study involving 98 cancer patients undergoing chemotherapy, music therapy was found to significantly reduce post-chemotherapy anxiety more effectively than verbal relaxation or usual care, particularly benefiting those with high state anxiety.

Both music therapy and verbal relaxation were effective in alleviating anxiety, but music therapy also led to an increase in skin temperature, suggesting a physiological response that may enhance patient comfort during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of the effect of music therapy and verbal relaxation on chemotherapy-induced anxiety. Lin, MF., Hsieh, YJ., Hsu, YY., et al.[2011]

In a clinical trial involving 120 female breast cancer patients, music therapy significantly reduced state anxiety levels compared to routine nursing care alone, with lower anxiety scores observed at three different post-test measurements.

The study demonstrated that music therapy can be an effective complementary intervention for managing anxiety in patients following radical mastectomy, highlighting its potential role in holistic cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. Li, XM., Zhou, KN., Yan, H., et al.[2022]

In a study involving 22 pediatric patients aged 8 to 16 undergoing ambulatory chemotherapy, music therapy significantly reduced anxiety levels compared to standard treatment alone.

All patients initially experienced moderate to high anxiety, but those who received music therapy on the second day of treatment reported lower anxiety levels after chemotherapy, highlighting the effectiveness of music as an adjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music as an adjuvant treatment for anxiety in pediatric oncologic patients]. Sepúlveda-Vildósola, AC., Herrera-Zaragoza, OR., Jaramillo-Villanueva, L., et al.[2014]

In a study of 170 Chinese female breast cancer patients, those who received music therapy and progressive muscle relaxation training showed significant reductions in depression and anxiety compared to those who only received routine nursing care.

Patients in the intervention group also experienced a shorter hospital stay, averaging 12.56 days, compared to 17.01 days for the control group, indicating that these therapies may enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: results on depression, anxiety and length of hospital stay. Zhou, K., Li, X., Li, J., et al.[2022]

In a randomized clinical trial involving breast cancer patients undergoing chemotherapy, a 30-minute music intervention before treatment significantly improved quality of life scores compared to a control group.

The music group also experienced lower levels of depression and anxiety, as well as reduced incidence of vomiting during chemotherapy, indicating that music can be an effective complementary therapy to alleviate some adverse effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. Lima, TU., Moura, ECR., Oliveira, CMB., et al.[2021]

A systematic review of 13 randomized controlled trials on music interventions for reducing anxiety in adult cancer patients found that while many individual studies reported significant anxiety reductions, the overall meta-analysis did not show a significant effect compared to control groups.

The lack of significant findings in the meta-analysis may be due to small sample sizes and variability in study methodologies, indicating a need for further research to identify effective music intervention strategies for specific cancer populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of music interventions on anxiety for adult cancer patients: a meta-analysis and systematic review. Nightingale, CL., Rodriguez, C., Carnaby, G.[2022]

In a study involving 200 oncology patients, music therapy significantly reduced pre-radiotherapy anxiety levels compared to a control group, with notable decreases in both State and Trait anxiety scores.

Patients who received music therapy also experienced a greater reduction in systolic blood pressure compared to those who rested, indicating that music intervention can have beneficial physiological effects alongside psychological relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifteen-minute music intervention reduces pre-radiotherapy anxiety in oncology patients. Chen, LC., Wang, TF., Shih, YN., et al.[2013]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11194329

Determining the Feasibility of Virtual Tailored, Music-Based ... Abstract Text. Clinical Problem: Up to 48.5% of adolescent and young adult (AYA, 15 – 39 years old) cancer survivors experience clinically relevant anxiety.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05911269

Feasibility of Virtual, Tailored, Music-Based Relaxation for ... Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors · Study Overview · Contacts and Locations.

3. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R34CA286712

Funded Grants | Division of Cancer Prevention Clinical Problem: Up to 48.5% of adolescent and young adult (AYA, 15 – 39 years old) cancer survivors experience clinically relevant anxiety.

4. withpower.com withpower.com/trial/phase-anxiety-disorders-5-2023-7d020

Music-Based Relaxation for Anxiety in Young Cancer ... TiMBRe is unique because it uses music-based relaxation specifically designed to reduce anxiety in young cancer survivors, focusing on elements like tone, ...

5. reporter.nih.gov reporter.nih.gov/search/9g19YGuPFkO5dvsExH60-A/project-details/10952065

Project Details Clinical Problem: Up to 48.5% of adolescent and young adult (AYA, 15 – 39 years old) cancer survivors experience clinically relevant anxiety.

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct05911269

Feasibility of Virtual, Tailored, Music-Based Relaxation for ... ... music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447645/

Effect of group music therapy on state-anxiety and well-being ... The results suggest that group music therapy during chemotherapy is a safe and effective strategy to improve mental health and well-being in ...