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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02970617
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Distress Malignant Neoplasm Other: Memory Intervention Other: Questionnaire Administration Radiation: Radiation therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Group A (no bell after final radiation)
Patients undergo standard of care radiation therapy with or without chemotherapy.
Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation therapy
Radiation therapy with or without chemotherapy

Experimental: Group B (ring bell after final radiation treatment)
On the final day of standard of care radiation therapy, patients ring a bell in the clinic.
Other: Memory Intervention
Ring bell after final radiation treatment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation therapy
Radiation therapy with or without chemotherapy




Primary Outcome Measures :
  1. Distress memory scales as assessed by the 11-point Numeric Rating Scale [ Time Frame: Up to 7 months ]
    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.


Secondary Outcome Measures :
  1. Anxiety level as assessed by Generalized Anxiety Disorder 7 scale [ Time Frame: Up to 7 months ]
    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.

  2. Optimism-pessimism scores as assessed by the Life Orientation Test-Revised [ Time Frame: Up to 7 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970617


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Patrick Williams University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02970617    
Other Study ID Numbers: OS-15-15
NCI-2016-01259 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OS-15-15 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Neoplasms