Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers

Quality of Life Clinical Trial

Official title:

A Structured Multidisciplinary Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment & Their Caregivers: A Telemedicine Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094780
• Other study ID #: 15-009226
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 21, 2019

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will use video technology in conjunction with in-person participation. This is a pilot project, where all enrolled participants will receive the multidisciplinary intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend an in-person group session, and participants (patients and caregivers) from Mayo Clinic Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use of video conferencing. The goals are to examine feasibility (percent of eligible patients and caregivers who enroll), attrition, and adherence (attend at least four of the six sessions), to determine any differences between the two formats, and to examine potential QOL differences as a result of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 21, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age.

• Ability to attend all treatment sessions and follow-up.

• Ability to provide written informed consent.

• Ability to participate in all aspects of the study.

• Initial diagnosis of cancer must have been 12 months prior to study entry.

• Intermediate to poor prognosis, defined as an expected 5-year survival of 0%-50% in the judgment of the physicians entering the patient on the study.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.

• 1 week of planned cancer treatment (radiation or chemotherapy) at Mayo Clinic.

• Has a caregiver also willing to participate.

• Willingness to get e-mail/text reminder to complete the follow-up survey or complete the follow-up survey with a study coordinator by phone.

Exclusion Criteria:

• Expected survival of <6 months.

• Active substance abuse (alcohol or drug).

• Participation in other psycho-social research trials.

• Active untreated thought disorder (bipolar illness, schizophrenia, etc.).

• Untreated suicidal intent or plan.

• In need of psychiatric hospitalization.

• Recurrent disease after disease-free interval of >6 months.

• Previous cancer 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer).

• Use of Proton Beam Radiation.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms
• Quality of Life

Intervention

Behavioral:
• Quality of life counseling
Will receive quality of life counseling from PI, social workers, and physical therapists

Other:
• Video-conference quality of life counseling
Participants may video-conference to other sites to participate in group session dependent on Florida, Northfield and Arizona enrollment

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Mayo Clinic	Northfield	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the participant's QOL at 4 weeks (end of the intervention)	Quality of Life, 0 to 10. 7 or higher is positive.	baseline, 4 weeks
Primary	Change in the participant's QOL at 26 weeks	Quality of Life, 0 to 10. 7 or higher is positive.	baseline, 26 weeks

External Links

•   Mayo Clinic Clinical Trials