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OpenTrials
Completed

NCT Number: NCT03094780

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

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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Key information

Conditions

Quality of Life Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Jacksonville, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

Quality of life counseling

Behavioral

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

Video-conference quality of life counseling

Other

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

Primary outcomes

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

    Time frame: baseline, 4 weeks

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

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

    Time frame: baseline, 26 weeks

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 29, 2017
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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