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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03094780
Enrollment
20
Registered
2017-03-29
Start date
2016-07-31
Completion date
2019-02-21
Last updated
2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Quality of Life

Brief 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.

Interventions

BEHAVIORALQuality of life counseling

Will receive quality of life counseling from PI, social workers, and physical therapists

OTHERVideo-conference quality of life counseling

Participants may video-conference to other sites to participate in group session dependent on Florida, Northfield and Arizona enrollment

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the participant's QOL at 4 weeks (end of the intervention)baseline, 4 weeksQuality of Life, 0 to 10. 7 or higher is positive.
Change in the participant's QOL at 26 weeksbaseline, 26 weeksQuality of Life, 0 to 10. 7 or higher is positive.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026