Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment

Completed

• Conditions: Malignant Neoplasm
• Interventions: Procedure: quality-of-life assessment; Behavioral: telephone-based intervention; Other: questionnaire administration; Other: counseling intervention; Procedure: standard follow-up care; Behavioral: exercise intervention; Other: educational intervention

• Registration Number: NCT01360814
• Lead Sponsor: Mayo Clinic

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-03-13
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-26
• Study Completion: 2018-07-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GROUP A (multidisciplinary intervention)	questionnaire administration	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)	quality-of-life assessment	Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.
GROUP A (multidisciplinary intervention)	counseling 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)	questionnaire administration	Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.
GROUP A (multidisciplinary intervention)	exercise 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 A (multidisciplinary intervention)	quality-of-life assessment	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 A (multidisciplinary intervention)	telephone-based 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)	standard follow-up care	Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.
GROUP A (multidisciplinary intervention)	educational 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)	telephone-based intervention	Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.

Primary Outcome Measures

Name	Time	Method
Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score	At baseline and 4, 27, and 52 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States