DistressNCT02970617
Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients
A study testing Memory Intervention and Questionnaire Administration in people with Distress and Malignant Neoplasm, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Malignant Neoplasm
- What is being tested?
- Memory Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Distress, Malignant Neoplasm
- Being tested
- Memory Intervention, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory InterventionOther
Ring bell after final radiation treatment
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (no bell after final radiation) | Active comparator | Patients undergo standard of care radiation therapy with or without chemotherapy. Receives: 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. Receives: Other: Memory Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 months
Secondary outcomes (2)
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.
Measured: Up to 7 months
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.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start15 Aug 2016
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DistressStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick Williams, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970617
- Sponsor's protocol ID
- OS-15-15
- Other IDs
- NCI-2016-01259, OS-15-15, P30CA014089
- Status last verified
- Apr 2020
- First submitted
- 15 Nov 2016
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment
- ClinicalTrials.gov ID
- NCT02970617
- Acronym / sponsor ID
- OS-15-15
- Conditions
- Distress, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (no bell after final radiation) | Active comparator | Other: Questionnaire AdministrationPatients undergo standard of care radiation therapy with or without chemotherapy. |
| Group B (ring bell after final radiation treatment) | Experimental | Other: Memory Intervention, Other: Questionnaire AdministrationOn the final day of standard of care radiation therapy, patients ring a bell in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory InterventionRing bell after final radiation treatment | Other | Group B (ring bell after final radiation treatment) |
| Questionnaire AdministrationAncillary studies | Other | Group A (no bell after final radiation), Group B (ring bell after final radiation treatment) |
Primary outcome
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.
2 secondary outcomes
Anxiety level as assessed by Generalized Anxiety Disorder 7 scale
Time frame: Up to 7 months
Optimism-pessimism scores as assessed by the Life Orientation Test-Revised
Time frame: Up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Williams principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Intervention and Questionnaire Administration in people with Distress and Malignant Neoplasm, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress memory scales as assessed by the 11-point Numeric Rating Scale (time frame: Up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.