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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01099 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0290 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or low grade glioma or tumors that have spread to the brain and their partners. A couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.
PRIMARY OBJECTIVES:
I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners.
II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group.
EXPLORATORY OBJECTIVES:
I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (CBMB PROGRAM): Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.
GROUP II (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
After completion of study, patients are followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (CBMB program) | Experimental | Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life. |
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| Group II (waitlist control) | Active Comparator | Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-Body Intervention Procedure | Procedure | Undergo CBMB program |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual | Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable. | Up to 6 weeks |
| Feasibility of CBMB program as determined by attrition | Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable. | Up to 6 weeks |
| Feasibility of CBMB program as determined by adherence | Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable. | Up to 6 weeks |
| Feasibility of CBMB program as determined by acceptability | Trial considered feasible if > 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable. | Up to 6 weeks |
| CBMB program efficacy | Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance. | Up to 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| CBMB program efficacy on quality of life (QOL) outcomes | Will examine treatment mediators and moderators. Will examine if treatment efficacy on QOL outcomes measured at T3 is potentially achieved through improved mindfulness, self-compassion, holding back and intimacy measured at T2 using linear regression analysis in both a and b paths. Ninety percent bootstrap CIs will be constructed to assess the significance of the indirect effects defined using the product-of-coefficient approach. Linear regression analysis or multi-level modeling will be used to test for the interaction effects between treatment and baseline mindfulness, self-compassion, holding back and intimacy, as well as baseline medical and demographic factors (i.e., sex, age, and Karnofsky performance status), each at a two-sided significance level of 0.1. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathrin Milbury | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 3 months after completion of study |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |