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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-02-21

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.

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Detailed Description

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Conditions

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Quality of Life Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Quality of Life Counseling

Group Type OTHER

Quality of life counseling

Intervention Type BEHAVIORAL

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

Video-conference quality of life counseling

Intervention Type OTHER

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

Interventions

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Quality of life counseling

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

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No