Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-009226
- Jacksonville, Florida: 15-009226
NCT ID: NCT03094780
Sponsor Protocol Number: 15-009226
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available