Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients

Malignant Neoplasm Clinical Trial

Official title:

Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970617
• Other study ID #: OS-15-15
• Secondary ID: NCI-2016-01259OS
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: November 15, 2018

Study information

• Verified date: April 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies how well ringing a bell on the final day of radiation therapy works in improving the memory of distress in cancer patients. Ringing a bell on the final day of radiation therapy may improve the memory of how painful the treatment was.

Description:

PRIMARY OBJECTIVES:

I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.

SECONDARY OBJECTIVES:

I. To measure the severity of patients' memory of distress from cancer treatment.

II. To assess the relationship between anxiety to actual distress and to remembered distress.

III. To assess the relationship between optimism-pessimism personality to actual distress and to remembered distress.

IV. To assess patient's cognitive dissonance reduction to actual distress and to remembered distress.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A (No bell ringing): Patients undergo standard of care radiation therapy with or without chemotherapy.

GROUP B (Bell ringing): On the final day of standard of care radiation therapy, patients ring a bell in the clinic.

After completion of study, patients are followed up for 7 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cancer

• Definitive radiation treatment with or without concurrent chemotherapy with curative intent; treatment prior to radiation therapy is acceptable (e.g. surgery, chemotherapy)

• Ability to understand and the willingness to sign a written informed consent; consents will be provided in English or Spanish

• Able to speak English or Spanish (questionnaires will be in English and Spanish)

Exclusion Criteria:

• Patients with either a malignant central nervous system (CNS)-primary cancer or with brain metastases; patients do not need to undergo brain imaging unless indicated per standard workup and management (e.g. advanced stage lung cancer receiving definitive therapy)

• Patients who will be receiving surgery or adjuvant chemotherapy within 1 month following radiation treatment

• Patients with widespread metastatic disease (> 3 distant metastases); patients with oligometastatic disease (=< 3 distant metastases) are allowed only if they are receiving definitive (curative) radiation therapy (RT) with or without chemotherapy

Related Conditions & MeSH terms

• Distress
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Memory Intervention
Ring bell after final radiation treatment
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation therapy
Radiation therapy with or without chemotherapy

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress memory scales as assessed by the 11-point Numeric Rating Scale	Patient baseline characteristics and treatment will be summarized in groups A and B. Repeated measures analysis of variance (ANOVA) will be used to compare distress memory scales between patients in group A and group B. A mixed regression model will be used to examine the effect of ringing the bell on the last day of radiotherapy on distress memory scales when considering covariates such as baseline patient characteristics, cancer type, radiotherapy total dose and duration, baseline distress scale, analgesic medication, disease recurrence status, optimism/pessimism personality and anxiety.	Up to 7 months
Secondary	Anxiety level as assessed by Generalized Anxiety Disorder 7 scale	Repeated measures ANOVA will be used to compare anxiety levels between patients in group A and group B. All p values will be two-sided at a significance level of 0.05.	Up to 7 months
Secondary	Optimism-pessimism scores as assessed by the Life Orientation Test-Revised	Repeated measures ANOVA will be used to compare optimisim-pessimism scores between patients in group A and group B. All p values will be two-sided at a significance level of 0.05.	Up to 7 months