Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment
NCT ID: NCT01360814
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
138 participants
OBSERVATIONAL
2005-01-31
2018-07-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To examine the efficacy of a structured multidisciplinary intervention compared to standard medical care on improving the subject's QOL as measured by the Functional Assessment of Cancer Therapy-General global summary score (FACT-G) at 4 weeks (or at end of the intervention), at 27 weeks and at 52 weeks.
SECONDARY OBJECTIVES:
I. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the subject's psychosocial functioning as measured by the 11 Linear Analogue Self Assessment (LASA) QOL scales, Profile of Mood States (POMS), the Functional Assessment of Chronic Illness Therapy-Spiritual well-being scale (FACIT-SP), Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors at 4 weeks (or at end of intervention), at 27 weeks and at 52 weeks.
II. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the caregiver's QOL as measured by the Caregiver QOL-Cancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS at 4, 27 and 52 weeks.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients receive six 90-minute sessions of multidisciplinary structured intervention comprising physical therapy, education, a cognitive-behavioral intervention, discussion and support, spiritual reflection, and a relaxation exercise over 2-4 weeks. Caregivers are invited to sessions 1, 3, 4, and 6. Patients may also receive brief telephone contact during the 6 month follow-up period.
GROUP B: Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.
After completion of study treatment, patients are followed up at 4 weeks (or at the end of intervention), at 27 weeks, and at 52 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GROUP A (multidisciplinary intervention)
Patients receive six 90-minute sessions of a multidisciplinary structured intervention comprising physical therapy, education, a cognitive-behavioral intervention, discussion and support, spiritual reflection, and a relaxation exercise over 2-4 weeks. Caregivers are invited to sessions 1, 3, 4, and 6. Patients may also receive brief telephone contact during the 6 month follow-up period.
quality-of-life assessment
Ancillary studies
telephone-based intervention
Receive multidisciplinary structured intervention
questionnaire administration
Ancillary studies
counseling intervention
Receive multidisciplinary structured intervention
exercise intervention
Receive multidisciplinary structured intervention
educational intervention
Receive multidisciplinary structured intervention
GROUP B (standard medical care)
Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
telephone-based intervention
Receive standard care
standard follow-up care
Receive standard care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
quality-of-life assessment
Ancillary studies
telephone-based intervention
Receive multidisciplinary structured intervention
questionnaire administration
Ancillary studies
counseling intervention
Receive multidisciplinary structured intervention
exercise intervention
Receive multidisciplinary structured intervention
educational intervention
Receive multidisciplinary structured intervention
telephone-based intervention
Receive standard care
standard follow-up care
Receive standard care
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 at Mayo Clinic
* Has a caregiver also willing to participate
Exclusion Criteria
* Expected survival of \< 6 months
* Active substance abuse (alcohol or drug)
* Participation in other psycho-social research trials
* Active thought disorder (bipolar illness, schizophrenia, etc.)
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew Clark, Ph.D.
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chock MM, Lapid MI, Atherton PJ, Kung S, Sloan JA, Richardson JW, Clark MM, Rummans TA. Impact of a structured multidisciplinary intervention on quality of life of older adults with advanced cancer. Int Psychogeriatr. 2013 Dec;25(12):2077-86. doi: 10.1017/S1041610213001452. Epub 2013 Sep 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2011-00670
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC0491
Identifier Type: OTHER
Identifier Source: secondary_id
2314-04
Identifier Type: OTHER
Identifier Source: secondary_id
MC0491
Identifier Type: -
Identifier Source: org_study_id