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

Study Overview
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Brief Summary
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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.

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

Conditions
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Quality of Life, Advanced Cancer

Intervention / Treatment
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* Behavioral: Quality of life counseling
* Other: Video-conference quality of life counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Quality of Life Counseling<br> | Behavioral: Quality of life counseling<br>* Will receive quality of life counseling from PI, social workers, and physical therapists<br>Other: Video-conference quality of life counseling<br>* Participants may video-conference to other sites to participate in group session dependent on Florida, Northfield and Arizona enrollment<br>|

What is the study measuring?
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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 |