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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00670 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC0491 | Other Identifier | Mayo Clinic Cancer Center | |
| 2314-04 | Other Identifier | Mayo Clinic IRB |
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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
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality-of-life assessment | Procedure | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Clark, Ph.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24001635 | Derived | 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. |
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| telephone-based intervention | Behavioral | Receive multidisciplinary structured intervention |
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| questionnaire administration | Other | Ancillary studies |
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| counseling intervention | Other | Receive multidisciplinary structured intervention |
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| exercise intervention | Behavioral | Receive multidisciplinary structured intervention |
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| educational intervention | Other | Receive multidisciplinary structured intervention |
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| telephone-based intervention | Behavioral | Receive standard care |
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| standard follow-up care | Procedure | Receive standard care |
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| 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 | 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 | At baseline and 4, 27 and 52 weeks |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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