Self-Assessment and Management for Chemotherapy-Induced Taste Changes

(TAS Trial)

Overseen By Mary L Hook, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Head/neck cancer, Dysgeusia, Eating disorder, others

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

Compensation: Varies

Number of Visits: 1

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the Taste Alteration Self-Assessment treatment different from other treatments for chemotherapy-induced taste changes?

The Taste Alteration Self-Assessment treatment is unique because it empowers patients to actively manage their taste changes through self-assessment and personalized strategies, rather than relying solely on medical interventions. This approach focuses on self-care and individual adaptation, which is not typically emphasized in standard treatments for taste changes caused by chemotherapy. ^{1 2 3 4 5}

What is the purpose of this trial?

The main questions it aims to answer are: 1. Does completing a standard assessment increase the detection of chemotherapy induced taste changes compared with usual care (no assessment)? What TA are experienced? Are there any patterns in TA symptom occurrence based on age, sex, race/ethnicity, cancer type, chemotherapy agent, etc. 2. Do patients take action to deal with the TA? What strategies are used? Do patients in the intervention group use the assessments to select interventions? 3. Do the interventions lessen TA symptoms and maintain food intake? Is the treatment (in-depth assessment and education) more effective in lessening the intensity of TA than usual care? Which level of assessment is needed to support symptom management to reduce symptom severity? Participants will: Complete baseline assessment before starting their initial chemotherapy infusion (all patients) Participate in baseline patient education based on assigned intervention (usual care vs. treatment) Engage in TA management between chemotherapy infusion clinic visits based on education Visit the clinic for chemotherapy infusions as scheduled; Complete TA assessments and reporting based on intervention; Work with nurse coaches to answer questions and help with the intervention. Complete study data collection on the 4th chemotherapy cycle (but continue intervention) Complete final data collection at 6 months

Research Team

Mary L Hook, PhD, RN

Principal Investigator

Aurora Sinai Medical Center

Eligibility Criteria

This trial is for individuals experiencing taste changes due to chemotherapy. Participants must be starting their initial chemotherapy and willing to complete assessments, engage in self-management, and work with nurse coaches. Specific details on inclusion or exclusion criteria are not provided.

Inclusion Criteria

Initiating chemotherapy (first day/first cycle) at participating clinics

My cancer is one of the most common types.

English speaking/reading (without an interpreter)

Exclusion Criteria

I have a genetic condition that affects my sense of taste.

I have someone legally designated to make decisions for me.

Known eating disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Education

Participants complete baseline assessment and receive patient education based on assigned intervention (usual care vs. treatment) before starting chemotherapy

1 week

1 visit (in-person)

Chemotherapy and Intervention

Participants engage in TA management between chemotherapy infusion clinic visits, complete TA assessments, and work with nurse coaches

4 chemotherapy cycles

Visits as per chemotherapy schedule

Data Collection and Continued Intervention

Complete study data collection on the 4th chemotherapy cycle and continue intervention

4 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, with final data collection at 6 months

6 months

Treatment Details

Interventions

• Taste Alteration Self-Assessment
• Taste Alteration Self-Management

Trial Overview The study tests if a standard assessment can better detect taste alterations (TA) from chemotherapy than usual care. It also examines the effectiveness of patient education and interventions in managing TA symptoms and maintaining food intake over six months.

Participant Groups

Group I: Treatment - TA Self-monitoring and Self-management Experimental Treatment 2 Interventions

The nurse-led intervention involves using a valid/reliable TA assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) and teaching the patient to use the assessments and the evidence-based Patient Education Sheet to select assessment-driven interventions to manage TA symptoms. Data is collected about the specific actions prescribed in the teaching tool to identify which interventions were used and their overall impact.

Group II: Control/Usual Care Active Control 1 Intervention

Chemotherapy infusion clinics deliver infusion services based on the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) Chemotherapy Administration Safety Standards (2020) including standard toxicity screening and providing standard chemotherapy patient education with general information for managing nausea and other gastrointestinal side effects and nutrition tips. Usual care patients will be supplemented with a single-item question to evaluate taste alteration severity and to gather information about what they are doing and their diet intake.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

Taste changes are a common side effect for patients undergoing chemotherapy with drugs like cisplatin, carboplatin, or cyclophosphamide, and these changes can significantly impact their ability to eat.

A self-care suggestion sheet was effective in helping patients manage taste changes, with strategies such as avoiding strong flavors, maintaining good oral hygiene, and eating smaller meals being particularly beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care strategies to cope with taste changes after chemotherapy. Rehwaldt, M., Wickham, R., Purl, S., et al.[2021]

In a study of 243 adult patients undergoing chemotherapy, a majority reported experiencing taste alterations (TAs), with the most common being difficulty in tasting saltiness, followed by umami and sweetness.

The severity and characteristics of TAs varied across different chemotherapy regimens and were linked to a decrease in quality of life, highlighting the need for healthcare professionals to assess and manage these side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence, Severity, and Self-Reported Characteristics of Taste Alterations in Patients Receiving Chemotherapy. Campagna, S., Gonella, S., Sperlinga, R., et al.[2019]

The Chinese version of the chemotherapy-induced taste alteration scale (C-CiTAS) was found to be a reliable and valid tool for assessing taste changes in 227 cancer patients undergoing chemotherapy, demonstrating strong psychometric properties.

The C-CiTAS showed good construct, convergent, and discriminant validity, with high reliability scores, including a Cronbach's alpha of 0.900 for the overall scale, indicating it is effective for evaluating taste alterations in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Chinese version of the chemotherapy-induced taste alteration scale. Pang, D., Qian, L., Chen, ZJ., et al.[2020]

Taste changes are a common and often severe side effect for patients undergoing chemotherapy, significantly impacting their quality of life, especially with drugs like cisplatin and doxorubicin.

Despite the frequency and distress caused by taste changes, healthcare providers rarely discuss this issue with patients or offer self-management strategies, highlighting a gap in patient care and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taste changes experienced by patients receiving chemotherapy. Wickham, RS., Rehwaldt, M., Kefer, C., et al.[2022]

Chemotherapy often leads to taste alterations in patients, significantly affecting their quality of life.

There is a need for consistent evaluation of taste changes in clinical practice to better support patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy-Induced Taste Alteration. Penna, S.[2023]

References

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

Self-care strategies to cope with taste changes after chemotherapy. [2021]

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

Prevalence, Severity, and Self-Reported Characteristics of Taste Alterations in Patients Receiving Chemotherapy. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Chinese version of the chemotherapy-induced taste alteration scale. [2020]

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

Taste changes experienced by patients receiving chemotherapy. [2022]

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

Chemotherapy-Induced Taste Alteration. [2023]