Hematopoietic and Lymphatic System NeoplasmNCT06709404
Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers
A study testing Telemedicine, Survey administration and Electronic health record review in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Telemedicine, Survey administration and Electronic health record review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary caregiver of a patient scheduled to receive CS+HIPEC at Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Access to a computer or smartphone and must have an email address
- 18 years of age or older at the time of consent
- The ability to understand and willingness to provide written informed consent
- The ability to read and write English
Who cannot join
- Patient declines access to their medical record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Katie Duckworth, PhD
About this study
Official title: Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the feasibility of a telehealth navigation intervention for CS+HIPEC caregivers.
SECONDARY OBJECTIVES:
- To assess the efficacy of the intervention on financial distress and depression in intervention and standard of care caregivers.
II. To compare financial distress in intervention caregivers as compared to standard of care caregivers.
III. To compare satisfaction with care experiences in intervention caregivers as compared to standard of care caregivers.
IV. To compare self-efficacy for navigating treatment-related costs in intervention caregivers as compared to standard of care participants.
- To compare self-reported community resource use among intervention and standard of care caregivers.
VI. To compare the quality of life over time in intervention caregivers as compared to standard of care caregivers.
VII. To compare social support over time in intervention caregivers as compared to standard of care caregivers.
VIII. To compare treatment satisfaction for intervention caregivers as compared to standard of care caregivers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery.
GROUP II: Participants receive standard caregiving experience on study.
After completion of study intervention, participants are followed up at 3, 6, 12, and 24 months.
- Being tested
- Telemedicine, Survey administration, Electronic health record review, Best Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Receive telehealth navigation intervention
Survey administrationOther
Ancillary studies
Electronic health record reviewOther
Ancillary studies
Best PracticeOther
Receive standard caregiving experience
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Telehealth intervention) | Experimental | Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery. Receives: Other: Telemedicine; Other: Survey administration; Other: Electronic health record review |
| Group 2 (Usual Care) | Active comparator | Participants receive standard caregiving experience on study. Receives: Other: Survey administration; Other: Electronic health record review; Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility)
Feasibility will be measured by the number of caregivers who complete the Center for Epidemiologic Studies-Depression Scale (CES-D). The 95% confidence interval for the observed rates will be calculated.
Measured: At 1 and 2 years
Secondary outcomes (8)
Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy
Depression will be based on the proportion of caregivers screening in with scores at or above 16, the score that indicates possible depression. These data will be dichotomized into depressed (yes/no) status and analyzed using a repeated measures logistic regression to see if the rate of depression changes. The model will include a time group interaction, and if that test is not significant, the term will be removed and the model refit to assess differences between groups and estimate change in CES-D score. The CES-D is a 20-item self-report measure developed to screen for depressive disorders. A score of ≥ 16 has been used as the cut-off score with higher scores indicating significant depressive symptoms. Caregivers who score ≥16 will be documented.
Measured: Up to 2 years
Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy
Will be measured using the adapted Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy item for caregivers. Repeated measures longitudinal models will be used to detect changes in these measures. Initially, the model will include a time group interaction, and if that test is not significant, the term will be removed and the model refit to assess differences between groups and estimate change in financial distress scores. Lower scores indicate greater financial distress; higher scores indicate better financial well being. Scores range from 0 to 44.
Measured: Up to 2 years
Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form
The results will be summarized and reported. This item is given once to the caregivers; these results will help to make changes to the intervention in future studies. Satisfaction scores will be compared between the 2 arms using an independent t-test.
Measured: Up to 2 years
Self-efficacy
The General Self Efficacy Scale is a ten-item scale with Likert-type items created to "assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Scores range from 10 to 40 with higher scores indicating greater self-efficacy
Measured: Up to 2 years
Self-reported community resource
Will be used among intervention and standard of care caregivers and will be reported as a proportion using these resources. The corresponding 95% confidence interval will also be reported. These rates can be compared between groups using a two-proportion Z-test.
Measured: Up to 2 years
Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC)
Will be measured using the Caregiver Quality of Life Index-Cancer scale for caregivers. Will be evaluated using repeated measures regression, with estimates of scores at the 5 time points reported and tested for differences across the 5 collection times. The CQOLC scale consists of 35 five-point Likert-type items. Scores range from 0-140 (Good 0-45, fair 46-90, poor 91-140). The CQOLC is made up of four subscales: Burden, Disruptiveness, Positive adaptation, and Financial concerns.
Measured: Up to 2 years
Social support - Medical Outcome Study Social Support Survey (MOS-SSS)
The MOS-SSS contains 19 functional support items hypothesized to measure five dimensions of social support: 1) emotional support, 2) informational support, 3) tangible support, 4) positive social interaction, and 5) affectionate support. Responses are on a five-point Likert-type scale ranging from 'none of the time' to 'all of the time.' Score range is 0-20. Total score is calculated by adding up the responses for each item. A higher score indicates a greater level of perceived social support.
Measured: Up to 2 years
Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE)
The FAMCARE scale is a 20-item self-report questionnaire that measures how satisfied family caregivers are with the healthcare provided to the patient and themselves. The scale uses a Likert scale ranging from 1 to 5, with 1 being "very satisfied" and 5 being "very dissatisfied". The FAMCARE scale can be scored as mean scores or percentages. The percentage score ranges from 20 to 100, with higher scores indicating greater caregiver satisfaction.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start31 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katie Duckworth, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709404
- Sponsor's protocol ID
- IRB00110615
- Other IDs
- P30CA012197, WFBCCC 98522
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT06709404
- Acronym / sponsor ID
- IRB00110615
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Nov 2024 (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.
This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.
Detailed description
PRIMARY OBJECTIVE:
- To assess the feasibility of a telehealth navigation intervention for CS+HIPEC caregivers.
SECONDARY OBJECTIVES:
- To assess the efficacy of the intervention on financial distress and depression in intervention and standard of care caregivers.
II. To compare financial distress in intervention caregivers as compared to standard of care caregivers.
III. To compare satisfaction with care experiences in intervention caregivers as compared to standard of care caregivers.
IV. To compare self-efficacy for navigating treatment-related costs in intervention caregivers as compared to standard of care participants.
- To compare self-reported community resource use among intervention and standard of care caregivers.
VI. To compare the quality of life over time in intervention caregivers as compared to standard of care caregivers.
VII. To compare social support over time in intervention caregivers as compared to standard of care caregivers.
VIII. To compare treatment satisfaction for intervention caregivers as compared to standard of care caregivers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery.
GROUP II: Participants receive standard caregiving experience on study.
After completion of study intervention, participants are followed up at 3, 6, 12, and 24 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Telehealth intervention) | Experimental | Other: Telemedicine, Other: Survey administration, Other: Electronic health record reviewParticipants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery. |
| Group 2 (Usual Care) | Active comparator | Other: Survey administration, Other: Electronic health record review, Other: Best PracticeParticipants receive standard caregiving experience on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary caregiver of a patient scheduled to receive CS+HIPEC at Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Access to a computer or smartphone and must have an email address
- 18 years of age or older at the time of consent
- The ability to understand and willingness to provide written informed consent
- The ability to read and write English
Key exclusion criteria (1 listed)
- Patient declines access to their medical record
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 |
|---|---|---|
| TelemedicineReceive telehealth navigation intervention | Other | Group 1 (Telehealth intervention) |
| Survey administrationAncillary studies | Other | Group 1 (Telehealth intervention), Group 2 (Usual Care) |
| Electronic health record reviewAncillary studies | Other | Group 1 (Telehealth intervention), Group 2 (Usual Care) |
| Best PracticeReceive standard caregiving experience | Other | Group 2 (Usual Care) |
Primary outcome
Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility)
Time frame: At 1 and 2 years
Feasibility will be measured by the number of caregivers who complete the Center for Epidemiologic Studies-Depression Scale (CES-D). The 95% confidence interval for the observed rates will be calculated.
8 secondary outcomes
Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy
Time frame: Up to 2 years
Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy
Time frame: Up to 2 years
Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form
Time frame: Up to 2 years
Self-efficacy
Time frame: Up to 2 years
Self-reported community resource
Time frame: Up to 2 years
Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC)
Time frame: Up to 2 years
Social support - Medical Outcome Study Social Support Survey (MOS-SSS)
Time frame: Up to 2 years
Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
Katie Duckworth principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine, Survey administration and Electronic health record review in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Wake Forest University Health Sciences 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 1 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (3367165772, Emily.Teal@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility) (time frame: At 1 and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.