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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09153 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-0380 | Other Identifier | M D Anderson Cancer Center | |
| R21CA256694 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial examines the acceptability and effect of a parenting support intervention for families coping with solid tumor that has spread to other places in the body (metastatic) or has come back (recurrent). Parenting support program may help to reduce common parenting concerns, improve communication between parents and children about cancer, and improve the overall psychological wellbeing of parents.
PRIMARY OBJECTIVES:
I. Examine the acceptability a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers. (Trial 1) II. Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers. (Trial 2) III. Evaluate the initial evidence for intervention efficacy relative to waitlist control (WLC) group regarding patient and spousal caregiver psychological symptoms (primary outcome) and parenting concerns and parenting efficacy (secondary outcomes) and patient end of life (EOL) healthcare utilization (exploratory outcome). (Trial 2) IV. Understand the patients and caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research. (Trial 2)
OUTLINE:
TRIAL 1: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.
TRIAL 2: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.
GROUP II: Participants receive standard of care.
After completion of study, participants in Trial 1 are followed up at 6 and 12 weeks and participants in Trial 2 are followed up at 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (education material, videoconference session) | Experimental | Examine the acceptability of a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers (cohort A) and 10 patients with an advanced cancer diagnosis and their family caregivers (cohort B). |
|
| Group II (waitlist control) | Active Comparator | Participants receive standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathrin Milbury | Contact | 713-745-2868 | kmilbury@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Kathrin Milbury | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M.D. Anderson Cancer Center | View source |
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| Educational Intervention | Other | Receive educational materials and attend videoconference sessions |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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