Clinical trial NCT02970617: Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients
Official title: Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Malignant Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Distress memory scales as assessed by the 11-point Numeric Rating Scale
timeFrame: Up to 7 months
Secondary outcomes:
measure: Anxiety level as assessed by Generalized Anxiety Disorder 7 scale
timeFrame: Up to 7 months
measure: Optimism-pessimism scores as assessed by the Life Orientation Test-Revised
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Patrick Williams
role: PRINCIPAL_INVESTIGATOR
References: