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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

Tracking Information
First Submitted Date  ICMJE November 15, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE August 15, 2016
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients
Official Title  ICMJE Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Distress
  • Malignant Neoplasm
Intervention  ICMJE
  • Other: Memory Intervention
    Ring bell after final radiation treatment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation therapy
    Radiation therapy with or without chemotherapy
Study Arms  ICMJE
  • Active Comparator: Group A (no bell after final radiation)
    Patients undergo standard of care radiation therapy with or without chemotherapy.
    Interventions:
    • Other: Questionnaire Administration
    • Radiation: Radiation therapy
  • 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.
    Interventions:
    • Other: Memory Intervention
    • Other: Questionnaire Administration
    • Radiation: Radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2020)
82
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
240
Actual Study Completion Date  ICMJE November 15, 2018
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970617
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Patrick Williams University of Southern California
PRS Account University of Southern California
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP