Music-Based Relaxation for Anxiety in Young Cancer Survivors

Overseen By Robert Knoerl

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Hearing impairment, Cancer treatment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.

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 data supports the effectiveness of the treatment TiMBRe for anxiety in young cancer survivors?

Research shows that music therapy can help reduce anxiety in cancer patients, including those undergoing chemotherapy and radiation therapy. Music has been used successfully as an additional treatment to lower anxiety levels in both adult and pediatric cancer patients. ^{1 2 3 4 5}

Is music-based relaxation safe for young cancer survivors?

Music-based relaxation has been studied in various cancer patients and is generally considered safe. It has been shown to improve quality of life and reduce anxiety, depression, and stress without any reported harmful effects. ^{1 2 3 6 7}

How is the treatment TiMBRe different from other treatments for anxiety in young cancer survivors?

TiMBRe is unique because it uses music-based relaxation specifically designed to reduce anxiety in young cancer survivors, focusing on elements like tone, rhythm, and harmony. Unlike standard anxiety treatments, which may involve medication or talk therapy, TiMBRe leverages the calming effects of music to help manage anxiety without the need for drugs. ^{1 2 3 8 9}

Research Team

Robert Knoerl

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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)

I am between 15 and 39 years old.

Speak/read English

Exclusion Criteria

Prognosis less than 3 months

Documentation of significant hearing impairment

I plan to start treatments for anxiety during the study.

Trial Timeline

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

Treatment Details

Interventions

• Control (Other)
• TiMBRe (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of the effect of music therapy and verbal relaxation on chemotherapy-induced anxiety. [2011]

2. Mexico pubmed.ncbi.nlm.nih.gov

[Music as an adjuvant treatment for anxiety in pediatric oncologic patients]. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Music as a therapeutic intervention for anxiety in patients receiving radiation therapy. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Fifteen-minute music intervention reduces pre-radiotherapy anxiety in oncology patients. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The impact of music interventions on anxiety for adult cancer patients: a meta-analysis and systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Live concerts reduce cancer inpatients' anxiety. [2018]

9. Scotland 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. [2022]