Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this two-year mixed methods study is to develop and test an intervention to improve cancer family caregivers' knowledge of care options (curative, palliative, and hospice care) and goals of care communication as part of a self-management (SM) training program.
The two specific aims of this project are to:
The investigators will address and accomplish aim 1 by taking the following steps:
To address and accomplish aim 2, the investigators will do the following:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Family caregivers of breast cancer patients who consent to participate in the study have a 50/50 chance of being randomized to the intervention group and will receive the booklet, Managing Cancer Care: A Caregiver's Guide (MCC-CG) (N=18) |
|
| Control | Active Comparator | Family caregivers of breast cancer patients who consent to participate in the study have a 50/50 chance of being randomized to the control group and will receive the Symptom Management Toolkit (N=17) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Managing Cancer Care: A Caregiver's Guide | Other | MCC-CG is a set of 7 printed modules including information about caregiver-nominated SM topics, conversation starters to facilitate communication with patients and providers, and links to caregiver resources. The modules are as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of Care Options (KOCO) | 11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care. | 3 months |
| Medical Communication Competence Scale (MCCS) | Adjusted to reflect views of the family caregiver, the MCCS will assess participants' communication skills, including information seeking, providing, and verifying, and socio-emotional communication will be measured using the MCCS. Each item on the MCCS is presented with a Likert scale ranging from 7 (strongly agree) to 1 (strongly disagree). | 3 months |
| Engagement in Cancer Self-Management Activities Scale (ECSMAS) | The 33-item ECSMAS was developed to measure cancer patients' self-reported self-management. The ECSMAS is organized around three conceptual domains derived from a metasynthesis of process of self-management in chronic illness: focus on illness needs, activating resources, and living with chronic illness. Items are adjusted to reflect views of the family caregiver, and an additional item has been added to the ECSMAS to assess caregivers' ability to manage transitions as a self-management skill (34 items total). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Goals of Care Conversation | This form documents frequency, perceived quality, and content of goals of care conversations with patients and providers, as well as capturing any transitions experienced. | 3 months |
| Caregiver Burden Scale (CBS) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic/Clinical form | Includes demographic data for caregivers and clinical data for the patient whom they provide care for. | Baseline |
| Health Care Utilization | Data is abstracted from participants' medical records, including use of the emergency room, unscheduled hospital admissions, admission to ICU, use of chemotherapy and radiation in the last two weeks of life, and referral to hospice, among other indicators of disease burden as specified by the Center to Advance Palliative Care. |
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dena J Schulman-Green, PhD | Yale School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21205833 | Background | McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, Wagner EH. Self-management: Enabling and empowering patients living with cancer as a chronic illness. CA Cancer J Clin. 2011 Jan-Feb;61(1):50-62. doi: 10.3322/caac.20093. Epub 2011 Jan 4. | |
| 22694739 | Background | Schulman-Green D, Ercolano E, Jeon S, Dixon J. Validation of the knowledge of care options instrument to measure knowledge of curative, palliative, and hospice care. J Palliat Med. 2012 Oct;15(10):1091-9. doi: 10.1089/jpm.2011.0514. Epub 2012 Jun 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Symptom Management Toolkit | Other | Along with an overview of symptom management, the Toolkit provides concise information on commonly experienced symptoms, including fatigue, alopecia, cognitive dysfunction, nausea and vomiting, and sleep problems, among others. Each chapter uses a question-and-answer format to cover the topics of who is most likely to experience the symptom, when and why the symptom may occur, how the symptom can be managed, and when to call a provider. Drs. Schulman-Green and McCorkle have previously tested the Symptom Toolkit in an attention-control group. |
|
This 22-item scale was developed to assess the experience of burden among caregivers, specifically addressing the dimensions of personal strain and role strain. Each item is presented with five response options ranging from 0-4 indicating "never", "rarely", "sometimes", "frequently", and "nearly always" sequentially.
| 3 months |
| Mishel Uncertainty in Illness Scale (MUIS) | Uncertainty will be measured using the 32-item MUIS, which was developed to measure the uncertainty adults perceive regarding symptoms, diagnosis, relationships, and planning for the future. Each item on the MUIS represents uncertainty in terms of a 5-point Likert-type format ranging from 1 (strongly disagree) to 5 (strongly agree). All items adjusted to reflect views of the caregiver. | 3 months |
| Caregiver Competence Scale | Self-efficacy will be measured using a 4-point Likert scale, with four questions total. | 3 months |
| Personal Gain Scale | Self-efficacy will be measured using a 4-point Likert scale, with four questions total. | 3 months |
| 3 months after 3-month data collection time point |
| 22551013 | Background | Schulman-Green D, Jaser S, Martin F, Alonzo A, Grey M, McCorkle R, Redeker NS, Reynolds N, Whittemore R. Processes of self-management in chronic illness. J Nurs Scholarsh. 2012 Jun;44(2):136-44. doi: 10.1111/j.1547-5069.2012.01444.x. Epub 2012 May 2. |
| 25771190 | Background | Grey M, Schulman-Green D, Knafl K, Reynolds NR. A revised Self- and Family Management Framework. Nurs Outlook. 2015 Mar-Apr;63(2):162-70. doi: 10.1016/j.outlook.2014.10.003. Epub 2014 Oct 15. |
| 23729228 | Background | Schulman-Green D, Jeon S. Printed guide improves knowledge of curative, palliative, and hospice care among women with metastatic breast cancer. Support Care Cancer. 2013 Oct;21(10):2651-3. doi: 10.1007/s00520-013-1864-x. Epub 2013 Jun 1. No abstract available. |
| 26537980 | Background | Schulman-Green D, Jeon S. Managing Cancer Care: a psycho-educational intervention to improve knowledge of care options and breast cancer self-management. Psychooncology. 2017 Feb;26(2):173-181. doi: 10.1002/pon.4013. Epub 2015 Nov 4. |
| 26855201 | Background | Hinchey J, Goldberg J, Linsky S, Linsky R, Jeon S, Schulman-Green D. Knowledge of Cancer Stage among Women with Nonmetastatic Breast Cancer. J Palliat Med. 2016 Mar;19(3):314-7. doi: 10.1089/jpm.2015.0133. Epub 2016 Feb 8. |
| 35670155 | Derived | Schulman-Green D, Linsky S, Blatt L, Jeuland J, Kapo J, Jeon S. Improving Breast Cancer Family Caregivers' Palliative Care Literacy: A Pilot Randomized Trial. J Fam Nurs. 2023 Feb;29(1):99-114. doi: 10.1177/10748407221099541. Epub 2022 Jun 7. |
| D017437 |
| Skin and Connective Tissue Diseases |