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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09572 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1278 | Other Identifier | M D Anderson Cancer Center | |
| K07CA222335 | U.S. NIH Grant/Contract | View source | |
| R01HL142732 | U.S. NIH Grant/Contract | View source |
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PI Request
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Kawut, Steven, MD | INDIV |
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This study adapts and assesses the effect of a multicomponent physical activity intervention in reducing psychosocial distress in cancer patients. This study aims to develop a program to help increase physical activity and reduce stress in cancer survivors who live in rural areas.
PRIMARY OBJECTIVES:
I. To adapt a multicomponent intervention (HH+AIM) that assesses the perspective of health care provider and cancer survivors about:
Ia. Needs related to psychosocial distress and health behaviors in rural patients with cancer.
Ib. Needs related to implementing interventions within the treatment setting. Ic. Barriers to intervention delivery/participate. Id. Preferred means/methods for referring participants and receiving information related to the intervention.
SECONDARY OBJECTIVES:
I. To assess time spent sitting in prolonged bouts of 20 consecutive minutes or more (minutes/day).
II. To assess daily number of steps (collected using the activPAL over 7 days at week 8, data will be averaging over 7 days to get minutes per day).
III. To assess psychosocial distress measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores.
IV. To assess health-related quality of life measured using the SF-36 short form.
OUTLINE:
PART I: Patients and providers complete a questionnaire and attend an interview over 1 hour.
PART II: Patients are randomized to 1 of 2 groups.
GROUP I: Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
GROUP II: Patients receive usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (physical activity intervention) | Experimental | Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks. |
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| Group II (usual care) | Active Comparator | Patients receive usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Attend face-to-face mind-body sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| To establish a multicomponent intervention that assesses the perspective of health care provider | Through study completion, an average of 1 year | |
| To establish a multicomponent intervention that assesses the perspective of cancer survivors | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scherezade Mama, MD | 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 |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2022 | Oct 21, 2024 |
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| Best Practice | Other | Receive usual care |
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| Informational Intervention | Other | Receive targeted text messages |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| 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 |
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