Head and Neck CancerNCT04552587
The HEART Study (Healthy Eating and Recovery Together)
A study testing Heart APP in people with Head and Neck Cancer and Survivorship, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Survivorship, Nutrition Aspect of Cancer
- What is being tested?
- Heart APP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 10 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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:
- 18 years and older
- Patients with stage I-IVB HNC of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region)
- In the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months
- Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener
Patient Exclusion Criteria:
- head and neck cancer patients who do not undergo treatment
- Patients who do not read or understand English
- Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
- Patients who do not have a smartphone for use in the study
Caregiver Inclusion Criteria:
- 18 years and older
- Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment
Caregiver Exclusion Criteria:
- Caregivers who do not read or understand English
- Caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. The clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. After the visit, the program will provide an App for caregivers with follow-up resources and mobile support for one month.
Read the detailed description
The long-term goal of this research is to improve physical, emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-Support program to prepare and support caregivers after treatment.
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be recruited to a single-arm intervention study to evaluate the feasibility, acceptability and short-term effects of a nutrition-focused mobile support system. The intervention includes 1) a clinic visit (offered in-person or virtually) with a tablet-based needs assessment at the end of or after completing treatment which will generate 2) a tailored care plan with messages, educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3) a caregiver App with encouragement, reminders and tips delivered through messaging and peer videos. Participants will complete baseline and 6-week follow-up surveys.
- Being tested
- Heart APP
- Keywords
- mHealth, Head and Neck Cancer, Survivorship, Caregiver
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart APPBehavioural
The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.
| Study group | Role | What they receive |
|---|---|---|
| HEART | Experimental | Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback. Receives: Behavioral: Heart APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.
Measured: 6 week follow-up visit
Intervention Delivery/ Fidelity
Number of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).
Measured: 6 week follow up visit
Intervention Reach
Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.
Measured: Baseline and 6 week follow up visit
Secondary outcomes (16)
Ease of Use/System Usability
System Usability Scale (SUS) - The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores indicating better usability.
Measured: 6 week follow up visit only (no baseline comparison)
Mean Score of Unmet Needs
30-item Cancer Survivors/Partners Unmet Needs instruments (CaSUN/ CaSPUN). Needs were endorsed on a yes/no basis, with a range of 0-30 total endorsed needs. A higher score indicates more endorsed needs. Average number of needs is reported.
Measured: Baseline and 6 week follow up visit
PROMIS Depression- Short Form (SF) v1.0 Form 8A
PROMIS Depression- SF v1.0 form 8A is an 8-item Patient-Reported Outcomes Measure Information System (PROMIS) short-form instrument. Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and "Always" whereby a higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 6 week followup indicates reduced depression.
Measured: Baseline and 6 week follow-up visit
Mean Score of Survivorship Readiness/Caregiver Preparedness
The 11-item Preparing for Life As a New Survivor (PLANS) Knowledge Subscale, developed at the University of Michigan, is utilized to evaluate survivor and caregiver (1) knowledge of diagnosis, treatment and side effects, and (2) communication with the cancer team regarding diagnosis, treatment and side effects and 3) preparedness for what to expect over the next year. Items are rated on a 6-point scale where: strongly disagree=1, moderately disagree =2, slightly disagree=3, slightly agree= 4, moderately agree=5 and strongly agree=6. Items were averaged, with a range of 1-6 with higher scores indicating higher levels of agreement.
Measured: Baseline and 6 week follow-up visit
Mean Score of Self-Efficacy
Based on the National Cancer Institute Follow-up Care Use Among Survivors (FOCUS) survey, two questions were asked: "How confident are you that you can get advice or information related to your/your loved one's cancer if you needed at this time?" and "How confident are you that you can (assist your loved one to) keep to the follow-up care schedule recommended by your doctors?" Participants rated items on a 5-point Likert scale where 0="Not at all confident" to 4= "Completely confident." Scores were averaged for each question, whereby higher scores indicated higher level of confidence. Change from baseline to 6 week follow up is also reported. Negative change indicates decline in self-efficacy.
Measured: Baseline and 6 week follow-up visit
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Coping was measured using a 5-item cancer-specific subscale version of the Dyadic Coping Inventory. Items are rated on a 5-point scale from 1 ("never") to 5 ("always"). Scores were averaged with a higher score indicating a better outcome. A decrease in change between baseline and 6 week followup visit indicates worsening outcome over time.
Dyadic Efficacy is an investigator developed 1-item question "How confident are you that you and your loved one can work together as a team to manage the cancer-related problems that come up?" Item was answered on a scale of 0 ("not at all confident") to 10 ("extremely confident"), with average score reported. A decrease in change between baseline and 6 week followup visit indicates worsening, where as an increase in change indicates improvement.
Measured: Baseline and 6 week follow-up visit
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
PROMIS Scale v1.2 - Global Health short form consists of 10 items that assess overall perceived quality of life and five general domains of health and functioning including overall physical health, mental health, social health, pain, and fatigue. Scoring uses a 5-point Likert scale with the response scores reversed (5=None to 1=Very severe) so that higher scores for responses always indicate better health. Raw scores are summed and converted to a T-score (mean score of 50, SD ± 10), Therefore a person with a T-score of 40 is one SD below the mean. A decrease in the change from baseline to 6 week follow up indicates worsening quality of life, whereas an increase indicates improvement.
Measured: Baseline and 6 week follow-up visit
Caregiver Burden
4-item screening version of the Zarit Burden Interview is a self-report measure of caregiver burden. Caregivers rate each item on a 5-point Likert scale (0=never, 4= nearly always). Higher scores indicate greater caregiver distress. Total score range: 0 to 16, ≥ 8: high burden. An increase in change from baseline to 6 week follow up visit indicates increased caregiver distress.
Measured: Baseline and 6 week follow up visit
Ease of Mobile App Use/User Engagement
Number of weekly prompt responses missed out of 184 total expected (23 caregivers given 2 prompts per week for 4 weeks).
Measured: 4 weeks during app use
Number of Participants With Care Plan Use Endpoints
Number of participants of use of care plan after session, including patient and caregiver report of "Referred to Care Plan again," "Used Care Plan," "Used educational materials," and "Shared Care Plan with others."
Measured: 6 week follow up visit
Percentage of Participants Rating App Satisfaction/ Perceived Importance
Ratings of satisfaction with app and prompts on a 6 point descriptive rating scale ranging from strongly agree to strongly disagree. Measurements reported below are count of participants who moderately or strongly agreed with individual prompts.
Measured: 6 week follow up visit
Process Monitoring Data
Resources needed: Session length overall, length of nursing portion of session, length of app training- number of minutes
Measured: After session completion
Change From Baseline in Nutritional Status Scale
Investigator-developed 1 item: "During the past two weeks, how satisfied have you been with your nutritional status (from Extremely satisfied (1) to Not at all satisfied (5))?"
Measured: Baseline and 6 week follow up visit
Change From Baseline in Symptom Distress/Symptom Management
Adapted Symptom Distress Scale 1 item scaled to assess how distressing symptoms are to participant. 0= not at all distressing, 10= extremely distressing
1 item to assess patient and caregiver perceptions concerning patient ability to manage symptoms. 0= can manage extremely well, 10= cannot manage at all
Measured: Baseline and 6 week follow up visit
Change From Baseline in Emotional Support
PROMIS Short Form v2.0 - Emotional Support - 4a is a 4-item questionnaire. Item banks (currently adults only) assess perceived feelings of being cared for and valued as a person; having confidant relationships. PROMIS instruments are scored using item-level calibrations. Each question usually has five response options ranging in value from one to five. Raw scores are the sum of values of the response to each question then rescaled to to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.
Measured: Baseline and 6 week follow up visit
Change From Baseline in Symptom Severity
MD Anderson Symptom Inventory (MDASI) Head and Neck Module- Includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 6 week follow up indicates improvement of symptoms.
Measured: Baseline and 6 week follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start4 Dec 2020
- Primary completion10 Oct 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Katherine Sterba, Medical University of South Carolina
- Investigators
- Katherine Sterba, PhD. MPH, Principal investigator, Medical University of SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552587
- Sponsor's protocol ID
- 0006621
- Other IDs
- R21CA215557-02
- Status last verified
- Jan 2023
- First submitted
- 3 Sep 2020
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04552587
- Acronym / sponsor ID
- 0006621
- Keywords
- mHealth, Head and Neck Cancer, Survivorship, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 20 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. The clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. After the visit, the program will provide an App for caregivers with follow-up resources and mobile support for one month.
Detailed description
The long-term goal of this research is to improve physical, emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-Support program to prepare and support caregivers after treatment.
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be recruited to a single-arm intervention study to evaluate the feasibility, acceptability and short-term effects of a nutrition-focused mobile support system. The intervention includes 1) a clinic visit (offered in-person or virtually) with a tablet-based needs assessment at the end of or after completing treatment which will generate 2) a tailored care plan with messages, educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3) a caregiver App with encouragement, reminders and tips delivered through messaging and peer videos. Participants will complete baseline and 6-week follow-up surveys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEART | Experimental | Behavioral: Heart APPPatients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback. |
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 |
|---|---|---|
| Heart APPThe HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support. | Behavioural | HEART |
Primary outcome
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Time frame: 6 week follow-up visit
Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.
Intervention Delivery/ Fidelity
Time frame: 6 week follow up visit
Number of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).
Intervention Reach
Time frame: Baseline and 6 week follow up visit
Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.
16 secondary outcomes
Ease of Use/System Usability
Time frame: 6 week follow up visit only (no baseline comparison)
Mean Score of Unmet Needs
Time frame: Baseline and 6 week follow up visit
PROMIS Depression- Short Form (SF) v1.0 Form 8A
Time frame: Baseline and 6 week follow-up visit
Mean Score of Survivorship Readiness/Caregiver Preparedness
Time frame: Baseline and 6 week follow-up visit
Mean Score of Self-Efficacy
Time frame: Baseline and 6 week follow-up visit
Mean Score of Dyadic Coping/ Dyadic Efficacy
Time frame: Baseline and 6 week follow-up visit
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
Time frame: Baseline and 6 week follow-up visit
Caregiver Burden
Time frame: Baseline and 6 week follow up visit
Ease of Mobile App Use/User Engagement
Time frame: 4 weeks during app use
Number of Participants With Care Plan Use Endpoints
Time frame: 6 week follow up visit
Percentage of Participants Rating App Satisfaction/ Perceived Importance
Time frame: 6 week follow up visit
Process Monitoring Data
Time frame: After session completion
Change From Baseline in Nutritional Status Scale
Time frame: Baseline and 6 week follow up visit
Change From Baseline in Symptom Distress/Symptom Management
Time frame: Baseline and 6 week follow up visit
Change From Baseline in Emotional Support
Time frame: Baseline and 6 week follow up visit
Change From Baseline in Symptom Severity
Time frame: Baseline and 6 week follow up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Katherine Sterba, PhD. MPH principal investigator
Medical University of SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart APP in people with Head and Neck Cancer and Survivorship, run by Medical University of South Carolina 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?
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 20 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria (time frame: 6 week follow-up visit). 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?
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 20 Jan 2023.