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

NCT02970617 | Completed DMC

• 3 other identifiers: OS-15-15NCI-2016-01259P30CA014089
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distress; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety level as assessed by Generalized Anxiety Disorder 7 scale

  Up to 7 months

• Optimism-pessimism scores as assessed by the Life Orientation Test-Revised

  Up to 7 months

Study Arms (2)

Group A (no bell after final radiation)

ACTIVE COMPARATOR

Patients undergo standard of care radiation therapy with or without chemotherapy.

Other: Questionnaire Administration

Group B (ring bell after final radiation treatment)

EXPERIMENTAL

On the final day of standard of care radiation therapy, patients ring a bell in the clinic.

Other: Memory Intervention; Other: Questionnaire Administration

Interventions

Memory Intervention OTHER

Ring bell after final radiation treatment

Group B (ring bell after final radiation treatment)

Questionnaire Administration OTHER

Ancillary studies

Group A (no bell after final radiation); Group B (ring bell after final radiation treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Patrick Williams

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 22, 2016
• Study Start: August 15, 2016
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: October 7, 2025

Record last verified: 2020-04

Locations

US (1)