Family CaregiversNCT02616107
Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
A study testing Managing Cancer Care: A Caregiver's Guide and Symptom Management Toolkit in people with Family Caregivers, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Caregivers
- What is being tested?
- Managing Cancer Care: A Caregiver's Guide and Symptom Management Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A family member of an individual with any stage of breast cancer receiving curative, palliative, or hospice care
- Aged 18+
- English speaking
- Live in Connecticut
- The patient for whom the participant is a caregiver has a six-month prognosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Smilow Cancer Hospital
New Haven, Connecticut, 06510
About this study
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:
- Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's Guide (MCC-CG), for family caregivers of patients with breast cancer to increase knowledge of care options, goals of care communication, and other SM skills.
- Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized controlled trial compared with an attention-control condition (symptom management education) on knowledge of care options, goals of care communication, and other key SM skills (engagement in SM, management of transitions and uncertainty, increasing self-efficacy, appropriate use of health care resources).
Read the detailed description
The investigators will address and accomplish aim 1 by taking the following steps:
- Conduct development focus groups with family caregivers of women with breast cancer.
- Develop the MCC-CG intervention prototype.
- Conduct feedback focus groups with family caregivers to evaluate the prototype.
- Revise the MCC-CG.
To address and accomplish aim 2, the investigators will do the following:
- Conduct a pilot RCT to evaluate the feasibility of recruiting and retaining a sample of family caregivers.
- Assess the initial efficacy of the MCC-CG to improve knowledge of care options, goals of care communication, and other SM skills.
- Estimate power and determine the best measures for a large RCT testing the MCC-PT and MCC-CG together.
- Conditions
- Family Caregivers
- Being tested
- Managing Cancer Care: A Caregiver's Guide, Symptom Management Toolkit
- Keywords
- Caregiver, Self-management, Care options, Goals of care, Breast cancer, Palliative care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Cancer Care: A Caregiver's GuideOther
Also called MCC-CG
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:
- Becoming a Cancer Caregiver [role, changes, challenges, adjusting, self-care]
- Basics of Cancer Caregiving [physical, functional, emotional, social, \& spiritual support; treatment timeline worksheet]
- Caregiver's Role in Managing Patient Care [who/what is involved; health care professionals worksheet]
- Managing Cancer Symptoms and Side Effects [common symptoms/side effects; maintaining health; nutrition \& exercise; medication management worksheet]
- Care Options: [information on curative, palliative and hospice care]
- Talking About Goals of Care [information on goals of care conversations]
- Managing Transitions [defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet]
Symptom Management ToolkitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Managing Cancer Care: A Caregiver's Guide |
| 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) Receives: Other: Symptom Management Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Care Options (KOCO)
11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.
Measured: 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).
Measured: 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).
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 months
Caregiver Burden Scale (CBS)
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.
Measured: 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.
Measured: 3 months
Caregiver Competence Scale
Self-efficacy will be measured using a 4-point Likert scale, with four questions total.
Measured: 3 months
Personal Gain Scale
Self-efficacy will be measured using a 4-point Likert scale, with four questions total.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startJul 2014
- Primary completion9 Nov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Dena-Schulman-Green, Yale University
- Investigators
- Dena J Schulman-Green, PhD, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616107
- Sponsor's protocol ID
- 1407014318
- Status last verified
- Mar 2017
- First submitted
- 18 Nov 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21205833Schulman-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.
PubMed 22694739Schulman-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.
PubMed 22551013Grey 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.
PubMed 25771190Schulman-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.
PubMed 23729228Schulman-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.
PubMed 26537980Hinchey 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.
PubMed 26855201Schulman-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.
PubMed 35670155
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
- ClinicalTrials.gov ID
- NCT02616107
- Acronym / sponsor ID
- 1407014318
- Conditions
- Family Caregivers
- Keywords
- Caregiver, Self-management, Care options, Goals of care, Breast cancer, Palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jul 2014
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's Guide (MCC-CG), for family caregivers of patients with breast cancer to increase knowledge of care options, goals of care communication, and other SM skills.
- Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized controlled trial compared with an attention-control condition (symptom management education) on knowledge of care options, goals of care communication, and other key SM skills (engagement in SM, management of transitions and uncertainty, increasing self-efficacy, appropriate use of health care resources).
Detailed description
The investigators will address and accomplish aim 1 by taking the following steps:
- Conduct development focus groups with family caregivers of women with breast cancer.
- Develop the MCC-CG intervention prototype.
- Conduct feedback focus groups with family caregivers to evaluate the prototype.
- Revise the MCC-CG.
To address and accomplish aim 2, the investigators will do the following:
- Conduct a pilot RCT to evaluate the feasibility of recruiting and retaining a sample of family caregivers.
- Assess the initial efficacy of the MCC-CG to improve knowledge of care options, goals of care communication, and other SM skills.
- Estimate power and determine the best measures for a large RCT testing the MCC-PT and MCC-CG together.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Managing Cancer Care: A Caregiver's GuideFamily 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 | Other: Symptom Management ToolkitFamily 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) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A family member of an individual with any stage of breast cancer receiving curative, palliative, or hospice care
- Aged 18+
- English speaking
- Live in Connecticut
- The patient for whom the participant is a caregiver has a six-month prognosis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Managing Cancer Care: A Caregiver's GuideAlso: MCC-CGMCC-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: 1. Becoming a Cancer Caregiver [role, changes, challenges, adjusting, self-care] 2. Basics of Cancer Caregiving [physical, functional, emotional, social, \& spiritual support; treatment timeline worksheet] 3. Caregiver's Role in Managing Patient Care [who/what is involved; health care professionals worksheet] 4. Managing Cancer Symptoms and Side Effects [common symptoms/side effects; maintaining health; nutrition \& exercise; medication management worksheet] 5. Care Options: [information on curative, palliative and hospice care] 6. Talking About Goals of Care [information on goals of care conversations] 7. Managing Transitions [defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet] | Other | Intervention |
| Symptom Management ToolkitAlong 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. | Other | Control |
Primary outcome
Knowledge of Care Options (KOCO)
Time frame: 3 months
11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.
Medical Communication Competence Scale (MCCS)
Time frame: 3 months
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).
Engagement in Cancer Self-Management Activities Scale (ECSMAS)
Time frame: 3 months
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).
5 secondary outcomes
Goals of Care Conversation
Time frame: 3 months
Caregiver Burden Scale (CBS)
Time frame: 3 months
Mishel Uncertainty in Illness Scale (MUIS)
Time frame: 3 months
Caregiver Competence Scale
Time frame: 3 months
Personal Gain Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Background: PubMed 21205833McCorkle 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.
- Background: PubMed 22694739Schulman-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.
- Background: PubMed 22551013Schulman-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.
- Background: PubMed 25771190Grey 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.
- Background: PubMed 23729228Schulman-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.
- Background: PubMed 26537980Schulman-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.
- Background: PubMed 26855201Hinchey 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.
- Derived from this study: PubMed 35670155Schulman-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dena J Schulman-Green, PhD principal investigator
Yale School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Cancer Care: A Caregiver's Guide and Symptom Management Toolkit in people with Family Caregivers, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Care Options (KOCO) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616107, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.