CClinicalTrials.gg
CompletedNCT03094780Updated Oct 4, 2019

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

An interventional study of Quality of life counseling and Video-conference quality of life counseling in Quality of Life and Advanced Cancer, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Quality of Life
  • Advanced Cancer

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In context

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 7,258 interventional studies indexed under Neoplasms.

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Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Quality of Life Counseling

    Behavioral: Quality of life counseling · Other: Video-conference quality of life counseling

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

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What researchers measure

Primary outcomes

  1. Change in the participant's QOL at 4 weeks (end of the intervention)

    Quality of Life, 0 to 10. 7 or higher is positive.

    Time frame: baseline, 4 weeks

  2. Change in the participant's QOL at 26 weeks

    Quality of Life, 0 to 10. 7 or higher is positive.

    Time frame: baseline, 26 weeks

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Study locations

3 sites
  • Mayo Clinic Jacksonville
    Jacksonville, Florida 32224, United States
  • Mayo Clinic
    Northfield, Minnesota 55057, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03094780
Lead sponsor
Mayo Clinic
Responsible party
Matthew M. Clark, Ph.D., L.P. (PI, Mayo Clinic) — Principal investigator
First posted
Mar 29, 2017
Start date
Jul 2016
Primary completion
Dec 2018
Completion
Feb 21, 2019
Last update
Oct 4, 2019

Study contacts

Matthew Clark, Ph.D., L.P.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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