Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment
A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial
3 other identifiers
observational
138
1 country
1
Brief Summary
This randomized clinical trial studies structured multidisciplinary intervention or standard medical care in improving quality of life (QOL) in patients receiving active cancer treatment. A structured multidisciplinary intervention may improve the QOL in patients receiving treatment for cancer. It is not yet known whether structured multidisciplinary intervention is more effective than standard medical care in improving QOL
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2009
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedDecember 18, 2019
May 1, 2019
4.2 years
May 23, 2011
December 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score
The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance \[ANOVA\], Generalized Estimating Equations \[GEE\]) will be used to measure and analyze QOL.
At baseline and 4, 27, and 52 weeks
Secondary Outcomes (2)
On improving the subject's psychosocial functioning as measured by the 11 LASA QOL scales, Profile of Mood States (POMS), the FACIT-SP, Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors
At baseline and 4, 27, and 52 weeks
On improving the caregiver's QOL as measured by the Caregiver QOLCancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS
At baseline and 4, 27 and 52 weeks
Study Arms (2)
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.
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.
Interventions
Ancillary studies
Receive multidisciplinary structured intervention
Ancillary studies
Receive multidisciplinary structured intervention
Receive multidisciplinary structured intervention
Receive multidisciplinary structured intervention
Eligibility Criteria
You may qualify if:
- 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 at Mayo Clinic
- Has a caregiver also willing to participate
You may not qualify if:
- Mini-mental state examination (MMSE) scores of \< 20
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 24001635DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Matthew Clark, Ph.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 26, 2011
Study Start
January 1, 2005
Primary Completion
March 13, 2009
Study Completion
July 2, 2018
Last Updated
December 18, 2019
Record last verified: 2019-05