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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA107383 | U.S. NIH Grant/Contract | View source | |
| UMCC 2003-094 | Other Identifier | University of Michigan | |
| IRBMED No. 2004-0129 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Wayne State University | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.
The purpose of this study is to:
A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief | Experimental | Dyads randomized to BRIEF arm received the Brief FOCUS Program (two home visits and one phone call by a trained nurse) in addition to standard clinical care. |
|
| Extensive | Experimental | Dyads randomized to EXTENSIVE arm received the Extensive FOCUS Program (4 home visits and two phone calls by a trained nurse) in addition to standard clinical care. |
|
| Control | No Intervention | Dyads randomized to CONTROL arm continued with standard clinical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief FOCUS Program | Behavioral | Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Baseline, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Risk for Distress | Baseline | |
| Change in Emotional Distress | Baseline, 3 and 6 months | |
| Change in Appraisal of Illness/Caregiving |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurel L Northouse, PhD, RN | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106 | United States | ||
| University of Michigan Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15990903 | Background | Northouse L. Helping families of patients with cancer. Oncol Nurs Forum. 2005 Jul 1;32(4):743-50. doi: 10.1188/05.onf.743-750. | |
| 22290823 | Result | Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, LoRusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31. |
| Label | URL |
|---|---|
| University of Michigan Comprehensive Cancer Center website | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| D003142 | Communication |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Extensive FOCUS Program | Behavioral | Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse. |
|
|
| Baseline, 3 and 6 months |
| Change in Uncertainty | Baseline, 3 and 6 months |
| Change in Hopelessness | Baseline, 3 and 6 months |
| Change in Self-efficacy | Baseline, 3 and 6 months |
| Change in Benefits of Illness | Baseline, 3 and 6 months |
| Change in Family Communication | Baseline, 3 and 6 months |
| Change in Support | Baseline, 3 and 6 months |
| Change in Depression | Baseline, 3 and 6 months |
| Change in Coping | Baseline, 3 and 6 months |
| Change in Health Care Resource Utilization | Baseline, 3 and 6 months |
| Change in Caregiver Burden | Baseline, 3 and 6 months |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Karmanos Cancer Center | Detroit | Michigan | 48202 | United States |
| Wayne State University | Detroit | Michigan | 48202 | United States |
| Providence Hospital Cancer Institute | Southfield | Michigan | 48075 | United States |
| 37794604 | Derived | Guan T, Chapman MV, de Saxe Zerden L, Zimmer C, Braden CJ, Rizo CF, Northouse L, Song L. Illness uncertainty and quality of life in patients with advanced cancer and their family caregivers: An actor-partner interdependence model analysis. Psychooncology. 2023 Nov;32(11):1744-1751. doi: 10.1002/pon.6228. Epub 2023 Oct 4. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |