Quality of LifeNCT03094780
Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers
A study testing Quality of life counseling and Video-conference quality of life counseling in people with Quality of Life and Advanced Cancer, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Advanced Cancer
- What is being tested?
- Quality of life counseling and Video-conference quality of life counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to 21 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic
Northfield, Minnesota, 55057
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Structured Multidisciplinary Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment & Their Caregivers: A Telemedicine Project
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.
- Conditions
- Quality of Life, Advanced Cancer
- Being tested
- Quality of life counseling, Video-conference quality of life counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life counselingBehavioural
Will receive quality of life counseling from PI, social workers, and physical therapists
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
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life Counseling | Other | Not described Receives: Behavioral: Quality of life counseling; Other: Video-conference quality of life counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the participant's QOL at 4 weeks (end of the intervention)
Quality of Life, 0 to 10. 7 or higher is positive.
Measured: baseline, 4 weeks
Change in the participant's QOL at 26 weeks
Quality of Life, 0 to 10. 7 or higher is positive.
Measured: baseline, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startJul 2016
- Primary completionDec 2018
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew M. Clark, Ph.D., L.P., Mayo Clinic
- Investigators
- Matthew Clark, Ph.D., L.P., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094780
- Sponsor's protocol ID
- 15-009226
- Status last verified
- Oct 2019
- First submitted
- 23 Aug 2016
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Multidisciplinary Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment & Their Caregivers: A Telemedicine Project
- ClinicalTrials.gov ID
- NCT03094780
- Acronym / sponsor ID
- 15-009226
- Conditions
- Quality of Life, Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Life Counseling | Other | Behavioral: Quality of life counseling, Other: Video-conference quality of life counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life counselingWill receive quality of life counseling from PI, social workers, and physical therapists | Behavioural | Quality of Life Counseling |
| Video-conference quality of life counselingParticipants may video-conference to other sites to participate in group session dependent on Florida, Northfield and Arizona enrollment | Other | Quality of Life Counseling |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Clark, Ph.D., L.P. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life counseling and Video-conference quality of life counseling in people with Quality of Life and Advanced Cancer, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the participant's QOL at 4 weeks (end of the intervention) (time frame: baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.