CancerFamCareNCT03532061
Caregivers' Strengths-Skills: Managing Older Cancer Patients' Symptoms
A study testing FamCare Program and Caregiver Support Group in people with Cancer, run by New York University.
Trial summary
Caregiver education and training programs that specifically target caregiver informational and training needs during the survivorship period have been limited. In recognition of families' direct involvement in health care decision-making, health advocacy and care provision, programs are needed that can maximize… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- FamCare Program and Caregiver Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2006to 31 Jul 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient Inclusion Criteria:
- Have a cancer diagnosis
- Have completed active treatment
- Be an older adult, aged 55 or older
- Have a family member who is their caregiver
- Understand English or Spanish
- Not be severely cognitively impaired
Patient Exclusion Criteria:
- Patient must be in the post-treatment period
Familial Caregiver Inclusion Criteria:
- Be 18 or older
- Live with or have frequent (at least weekly face-to-face) contact with patient
- Understand English or Spanish
Familial Caregiver Exclusion Criteria:
- Not be severely cognitively impaired
About this study
Official title: Enhancing Family Caregivers' Strengths and Skills in Managing Older Cancer Patients
Caregiver education and training programs that specifically target caregiver informational and training needs during the survivorship period have been limited. In recognition of families' direct involvement in health care decision-making, health advocacy and care provision, programs are needed that can maximize families' caregiving abilities and skills and provide them with the information and resources they may need to identify and address elderly cancer patients' post-treatment symptom management. The goal of this study was to implement and evaluate the efficacy of a short-term problem-solving skills training program (relative to participating in a caregiver support group) for familial caregivers to lower income older (55+) post-treatment cancer patients.
Read the detailed description
Cancer is one of the leading health disorders that can lead to impaired functioning and mortality in the elderly. With the aging of the population, more people will be living with a cancer diagnosis. The most dramatic increases will be among ethnic minorities. Advances in cancer detection and treatment are increasing cancer patients' survival and making it possible for many to be managed as outpatients and remain in the community. These advances have also contributed to an increased number of older adults living longer with/surviving for longer periods with having had cancer.
Recognition of the centrality of families' role in patients' treatment and recovery is widespread. Less attention, however, has been focused on developing programs and interventions that include or target the families' role during the cancer survivorship period, a period when patients are coping with the consequences of cancer and its treatment. During this period, when contact with the health care system is less intense, cancer patients' symptoms may go unrecognized or be poorly managed. Family members are directly involved in health care decision-making, functioning not only as a health care advocate for the elderly patient, but also ensuring that patients adhere to symptom management routines (e .g. encouraging them to take their pain medication, providing reassurance of the appropriateness of attending to certain symptoms). Family members' ongoing, frequent, contact with their elderly relative makes them ideally situated to monitor patients' functioning and detect subtle changes in their condition.
The goal of the proposed study was to implement and evaluate the utility of a brief training program to support and enhance the problem-solving caregiving skills of familial caregivers to facilitate optimum symptom control for older cancer patients during the post-treatment period. The rationale for this approach is based upon a diverse body of theoretical and empirical work. It represents a distillation and consolidation of research on cancer and the family, and draws from the broader bodies of work on disease management in the elderly, disparities in health care, cultural perspectives on illness, family caregiving in chronic disease, health behavior, health education and emerging approaches in palliative care.
Given the challenges patients and families may be experiencing during the post treatment period, ethical considerations mandated some type of service provision for the comparison condition. It was necessary to select an intervention that would be of potential benefit to the caregiver and/or the elderly patient, but would not necessarily be expected to directly impact the caregiver skills targeted in the Problem-solving condition. These considerations led to the selection of a caregiver support program as an acceptable comparison condition.
This investigation addresses a significant gap in the caregiver literature. While there is widespread recognition of the centrality of the family's role in long-term care situations, little attention has been focused on the post-treatment period. Programs that can empower familial caregivers and enhance their problem-solving strengths may enable them to be more effective in managing their relatives' care needs.
- Conditions
- Cancer
- Being tested
- FamCare Program, Caregiver Support Group
- Keywords
- Familial Caregiver, Cancer, Symptom Management, COPE Principles, Problem-solving Skills Training Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamCare ProgramBehavioural
6 in-person sessions of biweekly home care problem-solving skills training (FamCare) delivered by a health educator.
Caregiver Support GroupOther
6 in-person caregiver support group sessions held biweekly and moderated by a health educator.
| Study group | Role | What they receive |
|---|---|---|
| FamCare Group | Experimental | Family caregivers who receive 6 in-person problem-solving skills training sessions (FamCare Program). Receives: Behavioral: FamCare Program |
| Caregiver Support Group | Active comparator | Family caregivers who receive 6 in-person caregiver support group sessions. Receives: Other: Caregiver Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Social Problem-Solving Inventory Scale Score
Social Problem-Solving Inventory-Revised (SPSI-R:L): This is a 52 item instrument that measures one's ability to resolve problems encountered in everyday living. Scoring results in five standardized scale scores (1. Positive problem orientation; 2. Negative problem orientation; 3. Impulsivity/carelessness style; 4. Avoidance style; and 5. Rational problem solving), four Rational Problem Solving subscale scores (1. Problem definition formulation; 2. Generation of alternative solutions; 3. Decision making; and 4. Solution implementation and verification) and a Total SPSI-R:L standard score. Raw scores are converted to standard scores. The total SPSI-R:L score and each scale/subscale score has a mean of 100 and a standard deviation of 15. With the total SPSI-R:L score, higher scores indicate "good" social problem-solving ability. The extent to which "good" and "poor" problem-solving ability is demonstrated, is determined by observing how far the scores are from the mean score of 100.
Measured: Baseline, 1 & 7 months post-intervention delivery
Secondary outcomes (1)
Caregiver's Satisfaction with Quality of Patient Care - FAMCARE Scale Score
The impact of the short-term problem-solving skills training program on the caregiver's perceptions of and satisfaction with the quality of the patient's care relative to participating in the support condition, will be assessed utilizing the FAMCARE Scale. The FAMCARE Scale is a 20 item measure used to assess family satisfaction with health care of patients with advanced cancer. The scale contains 20 items and each item is a five-point Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied). The summary scale and individual subscales (Information giving, Availability of care, Physical care, and Pain control) are scored to range from 20-100, with high scores indicative of treatment/care dissatisfaction. To make the FAMCARE Scale easier to interpret, the scores were computed to reverse the scale such that higher values indicate higher satisfaction with care.
Measured: Baseline, 1 & 7 months post-intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start7 Aug 2006
- Primary completion14 Apr 2011
- Study completion31 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by New York 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Victoria H. Raveis, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532061
- Sponsor's protocol ID
- 10-01719
- Other IDs
- 7R01CA115315-06
- Acronym
- FamCare
- Status last verified
- May 2019
- First submitted
- 5 Apr 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raveis VH, Tobin J, Karus D, Zhou R, Faber KE, Carrero M, Estrada I. Family caregiving to older, minority cancer survivors living in the community: Perspectives from a randomized control trial of caregiver problem-solving skills training. The Gerontologist 51(S2):496, 2011.
Raveis VH, Tobin J, Karus D, Faber K, Zhou R, Carrero M, Estrada I. Family caregiving transitions: Addressing the care needs of older adults during the cancer survivorship period. The Gerontologist 50(S1): 475, 2010.
Raveis VH, Karus D, Zhou R, Carrero-Tagle M, Faber K, Estrada I, Tobin JN. FamCare: Cognitive-behavioral problem solving training for family caregivers to cancer survivors. Gerontologist 56(Suppl_3): 684, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Family Caregivers' Strengths and Skills in Managing Older Cancer Patients
- ClinicalTrials.gov ID
- NCT03532061
- Acronym / sponsor ID
- FamCare / 10-01719
- Conditions
- Cancer
- Keywords
- Familial Caregiver, Cancer, Symptom Management, COPE Principles, Problem-solving Skills Training Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Aug 2006 (actual)
- Primary completion
- 14 Apr 2011 (actual)
- Study completion
- 31 Jul 2011 (actual)
- First posted
- 22 May 2018 (actual)
- 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.
Caregiver education and training programs that specifically target caregiver informational and training needs during the survivorship period have been limited. In recognition of families' direct involvement in health care decision-making, health advocacy and care provision, programs are needed that can maximize families' caregiving abilities and skills and provide them with the information and resources they may need to identify and address elderly cancer patients' post-treatment symptom management. The goal of this study was to implement and evaluate the efficacy of a short-term problem-solving skills training program (relative to participating in a caregiver support group) for familial caregivers to lower income older (55+) post-treatment cancer patients.
Detailed description
Cancer is one of the leading health disorders that can lead to impaired functioning and mortality in the elderly. With the aging of the population, more people will be living with a cancer diagnosis. The most dramatic increases will be among ethnic minorities. Advances in cancer detection and treatment are increasing cancer patients' survival and making it possible for many to be managed as outpatients and remain in the community. These advances have also contributed to an increased number of older adults living longer with/surviving for longer periods with having had cancer.
Recognition of the centrality of families' role in patients' treatment and recovery is widespread. Less attention, however, has been focused on developing programs and interventions that include or target the families' role during the cancer survivorship period, a period when patients are coping with the consequences of cancer and its treatment. During this period, when contact with the health care system is less intense, cancer patients' symptoms may go unrecognized or be poorly managed. Family members are directly involved in health care decision-making, functioning not only as a health care advocate for the elderly patient, but also ensuring that patients adhere to symptom management routines (e .g. encouraging them to take their pain medication, providing reassurance of the appropriateness of attending to certain symptoms). Family members' ongoing, frequent, contact with their elderly relative makes them ideally situated to monitor patients' functioning and detect subtle changes in their condition.
The goal of the proposed study was to implement and evaluate the utility of a brief training program to support and enhance the problem-solving caregiving skills of familial caregivers to facilitate optimum symptom control for older cancer patients during the post-treatment period. The rationale for this approach is based upon a diverse body of theoretical and empirical work. It represents a distillation and consolidation of research on cancer and the family, and draws from the broader bodies of work on disease management in the elderly, disparities in health care, cultural perspectives on illness, family caregiving in chronic disease, health behavior, health education and emerging approaches in palliative care.
Given the challenges patients and families may be experiencing during the post treatment period, ethical considerations mandated some type of service provision for the comparison condition. It was necessary to select an intervention that would be of potential benefit to the caregiver and/or the elderly patient, but would not necessarily be expected to directly impact the caregiver skills targeted in the Problem-solving condition. These considerations led to the selection of a caregiver support program as an acceptable comparison condition.
This investigation addresses a significant gap in the caregiver literature. While there is widespread recognition of the centrality of the family's role in long-term care situations, little attention has been focused on the post-treatment period. Programs that can empower familial caregivers and enhance their problem-solving strengths may enable them to be more effective in managing their relatives' care needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FamCare Group | Experimental | Behavioral: FamCare ProgramFamily caregivers who receive 6 in-person problem-solving skills training sessions (FamCare Program). |
| Caregiver Support Group | Active comparator | Other: Caregiver Support GroupFamily caregivers who receive 6 in-person caregiver support group sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| FamCare Program6 in-person sessions of biweekly home care problem-solving skills training (FamCare) delivered by a health educator. | Behavioural | FamCare Group |
| Caregiver Support Group6 in-person caregiver support group sessions held biweekly and moderated by a health educator. | Other | Caregiver Support Group |
Primary outcome
Change in Caregiver Social Problem-Solving Inventory Scale Score
Time frame: Baseline, 1 & 7 months post-intervention delivery
Social Problem-Solving Inventory-Revised (SPSI-R:L): This is a 52 item instrument that measures one's ability to resolve problems encountered in everyday living. Scoring results in five standardized scale scores (1. Positive problem orientation; 2. Negative problem orientation; 3. Impulsivity/carelessness style; 4. Avoidance style; and 5. Rational problem solving), four Rational Problem Solving subscale scores (1. Problem definition formulation; 2. Generation of alternative solutions; 3. Decision making; and 4. Solution implementation and verification) and a Total SPSI-R:L standard score. Raw scores are converted to standard scores. The total SPSI-R:L score and each scale/subscale score has a mean of 100 and a standard deviation of 15. With the total SPSI-R:L score, higher scores indicate "good" social problem-solving ability. The extent to which "good" and "poor" problem-solving ability is demonstrated, is determined by observing how far the scores are from the mean score of 100.
1 secondary outcome
Caregiver's Satisfaction with Quality of Patient Care - FAMCARE Scale Score
Time frame: Baseline, 1 & 7 months post-intervention delivery
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 3 Nov 2022.
- BackgroundRaveis VH, Tobin J, Karus D, Zhou R, Faber KE, Carrero M, Estrada I. Family caregiving to older, minority cancer survivors living in the community: Perspectives from a randomized control trial of caregiver problem-solving skills training. The Gerontologist 51(S2):496, 2011.
- BackgroundRaveis VH, Tobin J, Karus D, Faber K, Zhou R, Carrero M, Estrada I. Family caregiving transitions: Addressing the care needs of older adults during the cancer survivorship period. The Gerontologist 50(S1): 475, 2010.
- Results publicationRaveis VH, Karus D, Zhou R, Carrero-Tagle M, Faber K, Estrada I, Tobin JN. FamCare: Cognitive-behavioral problem solving training for family caregivers to cancer survivors. Gerontologist 56(Suppl_3): 684, 2016.
- 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.
Victoria H. Raveis, PhD principal investigator
New York University
Questions about this trial
What is this clinical trial studying?
A study testing FamCare Program and Caregiver Support Group in people with Cancer, run by New York University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Caregiver Social Problem-Solving Inventory Scale Score (time frame: Baseline, 1 & 7 months post-intervention delivery). 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 NCT03532061, which also lists 3 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 3 Nov 2022.