NCT03094780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

August 23, 2016

Last Update Submit

October 2, 2019

Conditions

Quality of LifeAdvanced Cancer

Outcome Measures

Primary Outcomes (2)

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

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

    baseline, 4 weeks

  • Change in the participant's QOL at 26 weeks

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

    baseline, 26 weeks

Study Arms (1)

Quality of Life Counseling

OTHER
Behavioral: Quality of life counselingOther: Video-conference quality of life counseling

Interventions

Quality of life counselingBEHAVIORAL

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

Quality of Life Counseling
Video-conference quality of life counselingOTHER

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

Quality of Life Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Northfield, Minnesota, 55057, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Matthew Clark, Ph.D., L.P.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 23, 2016

First Posted

March 29, 2017

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

February 21, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations

US(3)