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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Advanced Cancer
• Intervention / Treatment: Behavioral: Quality of life counseling; Other: Video-conference quality of life counseling

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
  • Minnesota
    • Northfield, Minnesota, United States, 55057
      • Mayo Clinic
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Quality of Life Counseling	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in the participant's QOL at 26 weeks	Quality of Life, 0 to 10. 7 or higher is positive.	baseline, 26 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Clark, Ph.D., L.P., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): February 21, 2019

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 15-009226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No